- Home
- Drug Recall Enforcement Reports
- Recall Enforcement Event ID: 96474
Recall Enforment Report D-0342-2025
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Glenmark Pharmaceuticals Inc., USA, originally initiated on 03-13-2025 for the product Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-562-01 The product was recalled due to cgmp deviations. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0342-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-562-01 | CGMP Deviations | Ongoing |
| D-0329-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-325-60 | CGMP Deviations | Ongoing |
| D-0350-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India | CGMP Deviations | Ongoing |
| D-0322-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-694-97 | CGMP Deviations | Ongoing |
| D-0328-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC 68462-521-90. | CGMP Deviations | Ongoing |
| D-0316-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-409-60 | CGMP Deviations | Ongoing |
| D-0340-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-433-18 | CGMP Deviations | Ongoing |
| D-0332-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. | CGMP Deviations | Ongoing |
| D-0327-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-336-01 | CGMP Deviations | Ongoing |
| D-0336-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05. | CGMP Deviations | Ongoing |
| D-0348-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35 | CGMP Deviations | Ongoing |
| D-0351-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01. | CGMP Deviations | Ongoing |
| D-0349-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01 | CGMP Deviations | Ongoing |
| D-0323-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-713-08 | CGMP Deviations | Ongoing |
| D-0330-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-679-60 | CGMP Deviations | Ongoing |
| D-0326-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-338-01 | CGMP Deviations | Ongoing |
| D-0335-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-320-60 | CGMP Deviations | Ongoing |
| D-0344-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-144-01 | CGMP Deviations | Ongoing |
| D-0325-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-198-90. | CGMP Deviations | Ongoing |
| D-0339-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-264-30 | CGMP Deviations | Ongoing |
| D-0314-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-580-01 | CGMP Deviations | Ongoing |
| D-0347-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India | CGMP Deviations | Ongoing |
| D-0352-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01 | CGMP Deviations | Ongoing |
| D-0315-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-408-60 | CGMP Deviations | Ongoing |
| D-0317-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. | CGMP Deviations | Ongoing |
| D-0341-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. | CGMP Deviations | Ongoing |
| D-0324-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-639-45. | CGMP Deviations | Ongoing |
| D-0321-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-681-60. | CGMP Deviations | Ongoing |
| D-0337-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60 | CGMP Deviations | Ongoing |
| D-0343-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-680-60. | CGMP Deviations | Ongoing |
| D-0334-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-424-30 | CGMP Deviations | Ongoing |
| D-0333-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. | CGMP Deviations | Ongoing |
| D-0338-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01 | CGMP Deviations | Ongoing |
| D-0346-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01 | CGMP Deviations | Ongoing |
| D-0345-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. | CGMP Deviations | Ongoing |
| D-0319-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-572-30. | CGMP Deviations | Ongoing |
| D-0318-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-573-30 | CGMP Deviations | Ongoing |
| D-0320-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05. | CGMP Deviations | Ongoing |
| D-0331-2025 | 03-13-2025 | 04-16-2025 | Class II | N/A | Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-638-01 | CGMP Deviations | Ongoing |
Recalled Products
| NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
|---|---|---|---|---|---|---|
| 16714-558 | Pravastatin Sodium | Pravastatin Sodium | Tablet | Oral | Northstar Rxllc | Human Prescription Drug |
| 16714-559 | Pravastatin Sodium | Pravastatin Sodium | Tablet | Oral | Northstar Rxllc | Human Prescription Drug |
| 16714-560 | Pravastatin Sodium | Pravastatin Sodium | Tablet | Oral | Northstar Rxllc | Human Prescription Drug |
| 16714-570 | Pravastatin Sodium | Pravastatin Sodium | Tablet | Oral | Northstar Rxllc | Human Prescription Drug |
| 16714-825 | Propafenone Hydrochloride | Propafenone Hydrochloride | Capsule, Extended Release | Oral | Northstar Rx Llc | Human Prescription Drug |
| 16714-826 | Propafenone Hydrochloride | Propafenone Hydrochloride | Capsule, Extended Release | Oral | Northstar Rx Llc | Human Prescription Drug |
| 16714-827 | Propafenone Hydrochloride | Propafenone Hydrochloride | Capsule, Extended Release | Oral | Northstar Rx Llc | Human Prescription Drug |
| 68462-126 | Gabapentin | Gabapentin | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-127 | Gabapentin | Gabapentin | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-142 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-143 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-144 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-162 | Carvedilol | Carvedilol | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-163 | Carvedilol | Carvedilol | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-164 | Carvedilol | Carvedilol | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-165 | Carvedilol | Carvedilol | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-178 | Naproxen Sodium | Naproxen Sodium | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-179 | Naproxen Sodium | Naproxen Sodium | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-188 | Naproxen | Naproxen | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-189 | Naproxen | Naproxen | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-190 | Naproxen | Naproxen | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-195 | Pravastatin Sodium | Pravastatin Sodium | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-196 | Pravastatin Sodium | Pravastatin Sodium | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-197 | Pravastatin Sodium | Pravastatin Sodium | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-198 | Pravastatin Sodium | Pravastatin Sodium | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-261 | Rosuvastatin Calcium | Rosuvastatin Calcium | Tablet, Film Coated | Oral | Glenmark Pharmaceutials Inc., Usa | Human Prescription Drug |
| 68462-262 | Rosuvastatin Calcium | Rosuvastatin Calcium | Tablet, Film Coated | Oral | Glenmark Pharmaceutials Inc., Usa | Human Prescription Drug |
| 68462-263 | Rosuvastatin Calcium | Rosuvastatin Calcium | Tablet, Film Coated | Oral | Glenmark Pharmaceutials Inc., Usa | Human Prescription Drug |
| 68462-264 | Rosuvastatin Calcium | Rosuvastatin Calcium | Tablet, Film Coated | Oral | Glenmark Pharmaceutials Inc., Usa | Human Prescription Drug |
| 68462-319 | Ranolazine | Ranolazine | Tablet, Film Coated, Extended Release | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-320 | Ranolazine | Ranolazine | Tablet, Film Coated, Extended Release | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-325 | Indomethacin | Indomethacin | Capsule, Extended Release | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-336 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-337 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-338 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-386 | Solifenacin Succinate | Solifenacin Succinate | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-387 | Solifenacin Succinate | Solifenacin Succinate | Tablet, Film Coated, Extended Release | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-408 | Propafenone Hydrochloride | Propafenone Hydrochloride | Capsule, Extended Release | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-409 | Propafenone Hydrochloride | Propafenone Hydrochloride | Capsule, Extended Release | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-410 | Propafenone Hydrochloride | Propafenone Hydrochloride | Capsule, Extended Release | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-423 | Teriflunomide | Teriflunomide | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-424 | Teriflunomide | Teriflunomide | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-433 | Colesevelam Hydrochloride | Colesevelam Hydrochloride | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-520 | Metformin Hydrochloride | Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-521 | Metformin Hydrochloride | Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-562 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Capsule, Extended Release | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-572 | Voriconazole | Voriconazole | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-573 | Voriconazole | Voriconazole | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-580 | Fenofibrate | Fenofibrate | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-581 | Fenofibrate | Fenofibrate | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-582 | Fenofibrate | Fenofibrate | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-638 | Nitroglycerin | Nitroglycerin | Tablet | Sublingual | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-639 | Nitroglycerin | Nitroglycerin | Tablet | Sublingual | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-640 | Nitroglycerin | Nitroglycerin | Tablet | Sublingual | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-678 | Lacosamide | Lacosamide | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc. Usa | Human Prescription Drug |
| 68462-679 | Lacosamide | Lacosamide | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc. Usa | Human Prescription Drug |
| 68462-680 | Lacosamide | Lacosamide | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc. Usa | Human Prescription Drug |
| 68462-681 | Lacosamide | Lacosamide | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc. Usa | Human Prescription Drug |
| 68462-694 | Frovatriptan Succinate | Frovatriptan Succinate | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-713 | Rufinamide | Rufinamide | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-714 | Rufinamide | Rufinamide | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-726 | Saxagliptin | Saxagliptin | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-727 | Saxagliptin | Saxagliptin | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-850 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Capsule, Extended Release | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-851 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Capsule, Extended Release | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-889 | Prochlorperazine Maleate | Prochlorperazine Maleate | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-890 | Prochlorperazine Maleate | Prochlorperazine Maleate | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-914 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-947 | Prochlorperazine Maleate | Prochlorperazine Maleate | Tablet | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 72657-128 | Cetirizine Hcl | Cetirizine | Tablet | Oral | Glenmark Therapeutics Inc., Usa | Human Otc Drug |
| 72657-129 | Cetirizine Hcl | Cetirizine | Tablet | Oral | Glenmark Therapeutics Inc., Usa | Human Otc Drug |
| 72657-130 | Cetirizine Hcl | Cetirizine | Kit | Glenmark Therapeutics Inc., Usa | Human Otc Drug | |
| 72657-131 | Cetirizine Hcl | Cetirizine | Kit | Glenmark Therapeutics Inc., Usa | Human Otc Drug | |
| 72657-157 | Acetaminophen, Ibuprofen | Acetaminophen, Ibuprofen | Tablet, Film Coated | Oral | Glenmark Therapeutics Inc., Usa | Human Otc Drug |
Recall Enforcement Report D-0342-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0342-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-562-01
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17241067, exp. date May-26 17241628, exp. date Aug-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-850-01; 68462-851-01; 68462-562-01
- Status
- Ongoing
Recall Enforcement Report D-0329-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0329-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-325-60
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17232323, exp. date Oct-25 17232335, exp. date Oct-25 17232323, exp. date Oct-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-325-60; 68462-325-90; 68462-325-01; 68462-325-05; 68462-325-10
- Status
- Ongoing
Recall Enforcement Report D-0350-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0350-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17221770, exp. date Aug-25 17221774, exp. date Aug-25 17231251, exp. date May-26 17231262, exp. date May-26 17232112, exp. date Sep-26 17232133, exp. date Sep-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 16714-558-01; 16714-558-02; 16714-559-01; 16714-559-02; 16714-560-01; 16714-560-02; 16714-570-01; 16714-570-02
- Status
- Ongoing
Recall Enforcement Report D-0322-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0322-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-694-97
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17231352, exp. date Jun-25 17231649, exp. date Jul-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-694-97
- Status
- Ongoing
Recall Enforcement Report D-0328-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0328-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC 68462-521-90.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17232088, exp. date Sep-25 17232093, exp. date Sep-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-520-01; 68462-520-05; 68462-520-10; 68462-521-90; 68462-521-01; 68462-521-05
- Status
- Ongoing
Recall Enforcement Report D-0316-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0316-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-409-60
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17230767, exp. date Mar-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-408-60; 68462-409-60; 68462-410-60
- Status
- Ongoing
Recall Enforcement Report D-0340-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0340-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-433-18
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17240669, exp. date Mar-26 17240876, exp. date Apr-26 17240883, exp. date May-26 17240909, exp. date May-26 17240914, exp. date May-26 17240927, exp. date May-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-433-90; 68462-433-18
- Status
- Ongoing
Recall Enforcement Report D-0332-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0332-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17232460, exp. date Nov-25 17232460, exp. date Nov-25 17241194, exp. date Jun-26 17241194, exp. date Jun-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-726-30; 68462-726-90; 68462-726-05; 68462-727-30; 68462-727-90; 68462-727-05; 68462-727-14
- Status
- Ongoing
Recall Enforcement Report D-0327-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0327-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-336-01
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17232214, exp. date Sep-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-914-01; 68462-914-05; 68462-914-14; 68462-336-01; 68462-336-05; 68462-336-14; 68462-337-01; 68462-337-05; 68462-337-14; 68462-338-01; 68462-338-05; 68462-338-14
- Status
- Ongoing
Recall Enforcement Report D-0336-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0336-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17240238, exp. date Jan-26 17240243, exp. date Jan-26 17240245, exp. date Jan-26 17240248, exp. date Jan-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10
- Status
- Ongoing
Recall Enforcement Report D-0348-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0348-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17231980, ep.. date Aug-25 Amazon 17232044, ep.. date Aug-25 Walmart 17241436, ep.. date Jul-26 Amazon 17241437, ep.. date Jul-26 Amazon 17241455, ep.. date Jul-26 Amazon 17241456, ep.. date Aug-26 Amazon 17241457, ep.. date Aug-26 Amazon 17241892, ep.. date Oct-26 Amazon 17241893, ep.. date Oct-26 Amazon Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 72657-128-30; 72657-128-45; 72657-128-60; 72657-128-70; 72657-128-90; 72657-128-08; 72657-128-14; 72657-128-15; 72657-128-18; 72657-128-24; 72657-128-03; 72657-128-35; 72657-128-04; 72657-128-81; 72657-128-82; 72657-128-84; 72657-128-86; 72657-128-41; 72657-129-30; 72657-129-45; 72657-129-60; 72657-129-70; 72657-129-90; 72657-129-08; 72657-129-14; 72657-129-15; 72657-129-18; 72657-129-24; 72657-129-03; 72657-129-35; 72657-129-04; 72657-129-81; 72657-129-82; 72657-129-84; 72657-129-86; 72657-129-41; 72657-130-05; 72657-131-89
- Status
- Ongoing
Recall Enforcement Report D-0351-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0351-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17230819, exp. date Mar-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 16714-825-01; 16714-826-01; 16714-827-01
- Status
- Ongoing
Recall Enforcement Report D-0349-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0349-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17230810, exp. date Mar-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 16714-558-01; 16714-558-02; 16714-559-01; 16714-559-02; 16714-560-01; 16714-560-02; 16714-570-01; 16714-570-02
- Status
- Ongoing
Recall Enforcement Report D-0323-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0323-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-713-08
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17231643, exp. date Jul-25 17231644, exp. date Jul-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-713-30; 68462-713-08; 68462-713-05; 68462-714-08; 68462-714-05
- Status
- Ongoing
Recall Enforcement Report D-0330-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0330-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-679-60
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17232533, exp. date Nov-25 17232534, exp. date Nov-25 17240606, exp. date Mar-26 17240619, exp. date Mar-26 17240911, exp. date May-26 17240912, exp. date May-26 17241121, exp. date Jun-26 17241124, exp. date Jun-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-678-30; 68462-678-60; 68462-678-10; 68462-679-30; 68462-679-60; 68462-679-10; 68462-680-30; 68462-680-60; 68462-680-10; 68462-681-30; 68462-681-60; 68462-681-10
- Status
- Ongoing
Recall Enforcement Report D-0326-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0326-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-338-01
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17232206, exp. date Sep-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-914-01; 68462-914-05; 68462-914-14; 68462-336-01; 68462-336-05; 68462-336-14; 68462-337-01; 68462-337-05; 68462-337-14; 68462-338-01; 68462-338-05; 68462-338-14
- Status
- Ongoing
Recall Enforcement Report D-0335-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0335-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-320-60
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17240040, exp. date Dec-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-319-60; 68462-319-05; 68462-320-60; 68462-320-05
- Status
- Ongoing
Recall Enforcement Report D-0344-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0344-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-144-01
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17241278, exp. date Jul-26 17241297, exp. date Jul-26 17241304, exp. date Jul-26 17241315, exp. date Jul-26 17241327, exp. date Jul-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-142-01; 68462-143-01; 68462-143-05; 68462-144-01; 68462-144-81
- Status
- Ongoing
Recall Enforcement Report D-0325-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0325-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-198-90.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17221771, exp. date Aug-25 17230930, exp. date Apr-26 17230931, exp. date Apr-26 17231252, exp. date May-26 17231274, exp. date May-26 17231855, exp. date Aug-26 17231916, exp. date Aug-26 17231917, exp. date Aug-26 17231945, exp. date Aug-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-195-90; 68462-195-05; 68462-196-90; 68462-196-05; 68462-197-90; 68462-197-05; 68462-198-90; 68462-198-05
- Status
- Ongoing
Recall Enforcement Report D-0339-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0339-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-264-30
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17240389, exp. date Feb-26 17240390, exp. date Feb-26 17240426, exp. date Feb-26 17240427, exp. date Feb-26 17240428, exp. date Feb-26 17240778, exp. date Apr-26 17241055, exp. date May-26 17241074, exp. date Jun-26 17241075, exp. date Jun-26 17241091, exp. date Jun-26 17241100, exp. date Jun-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-261-30; 68462-261-50; 68462-261-90; 68462-261-01; 68462-261-10; 68462-261-11; 68462-262-30; 68462-262-50; 68462-262-90; 68462-262-01; 68462-262-10; 68462-262-11; 68462-263-30; 68462-263-50; 68462-263-90; 68462-263-01; 68462-263-10; 68462-263-11; 68462-264-30; 68462-264-50; 68462-264-90; 68462-264-01; 68462-264-05; 68462-264-10
- Status
- Ongoing
Recall Enforcement Report D-0314-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0314-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-580-01
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17230834, exp. date Mar-25 17230835, exp. date Mar-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-580-01; 68462-581-01; 68462-582-01
- Status
- Ongoing
Recall Enforcement Report D-0347-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0347-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17241302, exp. date Jul-26 Amazon & Walmart 17241140, exp. date Jul-26 Amazon & Walmart 17241141, exp. date Jul-26 Amazon & Walmart Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 72657-157-18; 72657-157-36; 72657-157-72; 72657-157-74; 72657-157-76; 72657-157-20; 72657-157-05
- Status
- Ongoing
Recall Enforcement Report D-0352-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0352-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17230767, exp. date Mar-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 16714-825-01; 16714-826-01; 16714-827-01
- Status
- Ongoing
Recall Enforcement Report D-0315-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0315-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-408-60
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17230819, exp. date Mar-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-408-60; 68462-409-60; 68462-410-60
- Status
- Ongoing
Recall Enforcement Report D-0317-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0317-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17230762, exp. date Mar-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-386-30; 68462-386-90; 68462-386-14; 68462-387-30; 68462-387-90; 68462-387-14
- Status
- Ongoing
Recall Enforcement Report D-0341-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0341-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17230810, exp. date Mar-26 17230811, exp. date Mar-26 17230810, exp. date Mar-26 17232501, exp. date Nov-26 17232502, exp. date Nov-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-195-90; 68462-195-05; 68462-196-90; 68462-196-05; 68462-197-90; 68462-197-05; 68462-198-90; 68462-198-05
- Status
- Ongoing
Recall Enforcement Report D-0324-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0324-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-639-45.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17232024, exp. date Aug-25 17232071, exp. date Sep-25 17232072, exp. date Sep-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-638-01; 68462-639-01; 68462-639-25; 68462-639-45; 68462-640-01
- Status
- Ongoing
Recall Enforcement Report D-0321-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0321-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-681-60.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17230982, exp. date Apr-25 17230986, exp. date, Apr-25 17231001, exp. date, Apr-25 17240197, exp. date Jan-26 17240198, exp. date Jan-26 17240215, exp. date Jan-26 17240846, exp. date Apr-26 17240847, exp. date Apr-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-678-30; 68462-678-60; 68462-678-10; 68462-679-30; 68462-679-60; 68462-679-10; 68462-680-30; 68462-680-60; 68462-680-10; 68462-681-30; 68462-681-60; 68462-681-10
- Status
- Ongoing
Recall Enforcement Report D-0337-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0337-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17240221, exp. date Jan-26 17240222, exp. date Jan-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-678-30; 68462-678-60; 68462-678-10; 68462-679-30; 68462-679-60; 68462-679-10; 68462-680-30; 68462-680-60; 68462-680-10; 68462-681-30; 68462-681-60; 68462-681-10
- Status
- Ongoing
Recall Enforcement Report D-0343-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0343-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-680-60.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17241125, exp. date Jun-26 17242202, exp. date Nov-26 17242204, exp. date Dec-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-678-30; 68462-678-60; 68462-678-10; 68462-679-30; 68462-679-60; 68462-679-10; 68462-680-30; 68462-680-60; 68462-680-10; 68462-681-30; 68462-681-60; 68462-681-10
- Status
- Ongoing
Recall Enforcement Report D-0334-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0334-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-424-30
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17232462, exp. date Nov-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-423-15; 68462-423-85; 68462-423-30; 68462-424-15; 68462-424-85; 68462-424-30
- Status
- Ongoing
Recall Enforcement Report D-0333-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0333-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- 30 count bottle: 17232395, exp. date Nov-25 17232400, exp. date Nov-25 90-count bottle: 17232395, exp. date Nov-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-386-30; 68462-386-90; 68462-386-14; 68462-387-30; 68462-387-90; 68462-387-14
- Status
- Ongoing
Recall Enforcement Report D-0338-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0338-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17240254, exp. date Jan-26 17240257, exp. date Jan-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-889-01; 68462-889-10; 68462-890-01; 68462-890-10; 68462-947-01; 68462-947-10
- Status
- Ongoing
Recall Enforcement Report D-0346-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0346-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17231956, exp. date Aug-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-188-01; 68462-188-05; 68462-189-01; 68462-189-05; 68462-190-30; 68462-190-50; 68462-190-01; 68462-190-05; 68462-178-01; 68462-178-05; 68462-179-01; 68462-179-05
- Status
- Ongoing
Recall Enforcement Report D-0345-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0345-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- 30-Count Bottle Lots: 17241788, exp. date Sep-26 17241821, exp. date Sep-26 17241822, exp. date Sep-26 90-Count Bottle Lot: 17241822, exp. date Sept 26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-726-30; 68462-726-90; 68462-726-05; 68462-727-30; 68462-727-90; 68462-727-05; 68462-727-14
- Status
- Ongoing
Recall Enforcement Report D-0319-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0319-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-572-30.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17231045, exp. date Apr-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-572-30; 68462-572-90; 68462-572-13; 68462-573-30; 68462-573-90; 68462-573-13
- Status
- Ongoing
Recall Enforcement Report D-0318-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0318-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-573-30
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17230853, exp. date Mar-25 17231271, exp. date May-25 17231300, exp. date May-25 17242050, exp. date Oct-26 17231046, exp. date Apr-25 17241156, exp. date Jun-26 17241388, exp. date Jul-26 17241800, exp. date Sep-26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-572-30; 68462-572-90; 68462-572-13; 68462-573-30; 68462-573-90; 68462-573-13
- Status
- Ongoing
Recall Enforcement Report D-0320-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0320-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17231015, exp. date Apr-25 17231128, exp. date Apr-25 17231138, exp. date Apr-25 17231139, exp. date Apr-25 17231143, exp. date Apr-25 17231144, exp. date Apr-25 17231848, exp. date Aug-25 17231898, exp. date Aug-25 17231977, exp. date Aug-25 17231978, exp. date Aug-25 17232015, exp. date Aug-25 17232016, exp. date Aug-25 17232017, exp. date Aug-25 17232034, exp. date Aug-25 17232041, exp. date Aug-25 17232396, exp. date Nov-25 17232406, exp. date Nov-25 17232410, exp. date Nov-25 17232490, exp. date Nov-25 17240326, exp. date Jan-26 17240327, exp. date Jan-26 17240383, exp. date Feb-26 17240395, exp. date Feb-26 17241863, exp. date Oct-26 17241869, exp. date Oct-26 17241870, exp. date Oct-26 17231256, exp. date May-25 17231386, exp. date May-25 17231387, exp. date May-25 17231407, exp. date May-25 17231417, exp. date May-25 17231418, exp. date May-25 17231754, exp. date Jul-25 17240085, exp. date Dec-25 17240117, exp. date Dec-25 17240131, exp. date Dec-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-126-01; 68462-126-05; 68462-127-01; 68462-127-05
- Status
- Ongoing
Recall Enforcement Report D-0331-2025
- Event ID
- 96474 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0331-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-638-01
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 04-16-2025
- Recall Initiation Date
- 03-13-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot # 17232361, exp. date Nov-25 17232367, exp. date Nov-25 17240037, exp. date Dec-25 17240038, exp. date Dec-25 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-638-01; 68462-639-01; 68462-639-25; 68462-639-45; 68462-640-01
- Status
- Ongoing
