Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0438-2025 | 04-24-2025 | Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 616,160 Tubes | Class II | Terminated |
| D-0435-2025 | 04-24-2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 19,500 Tubes | Class II | Terminated |
| D-0436-2025 | 04-24-2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 498,960 Tubes | Class II | Terminated |
| D-0437-2025 | 04-24-2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 4,176 boxes | Class II | Terminated |
| D-0431-2025 | 04-24-2025 | Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 391,680 Tubes | Class II | Terminated |
| D-0424-2025 | 04-24-2025 | Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6. | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 9,000 Bottles | Class II | Terminated |
| D-0426-2025 | 04-24-2025 | KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3. Package NDCs: 55758-109-02 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 11,808 Jars | Class II | Terminated |
| D-0440-2025 | 04-24-2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 160,848 Tubes | Class II | Terminated |
| D-0430-2025 | 04-24-2025 | Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 383,904 Tubes | Class II | Terminated |
| D-0422-2025 | 04-24-2025 | CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4. | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 10,128 Bottles | Class II | Terminated |
| D-0421-2025 | 04-24-2025 | Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-030-05, UPC 8 10096 77151 3. Package NDCs: 55758-030-05 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 9,984 Tubes | Class II | Terminated |
| D-0432-2025 | 04-24-2025 | Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 615, 600 Tubes | Class II | Terminated |
| D-0429-2025 | 04-24-2025 | Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9. Package NDCs: 55758-440-02; 55758-440-03 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 9,336 Tubes | Class II | Terminated |
| D-0433-2025 | 04-24-2025 | Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 1,559,000 Sachets | Class II | Terminated |
| D-0439-2025 | 04-24-2025 | Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 150,768 Tubes | Class II | Terminated |
| D-0434-2025 | 04-24-2025 | Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 216,720 Tubes | Class II | Terminated |
| D-0427-2025 | 04-24-2025 | Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6. | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 6,372 Tubes | Class II | Terminated |
| D-0423-2025 | 04-24-2025 | CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052. | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 10,788 Tubes | Class II | Terminated |
| D-0428-2025 | 04-24-2025 | Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10096 77158 2. Package NDCs: 55758-420-02; 55758-420-03 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 10,000 Tubes | Class II | Terminated |
| D-0405-2025 | 04-23-2025 | Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15. | cGMP deviations and lack of assurance of sterility. | BRS Analytical Services, LLC / 1,610 cases (24 cartons per case) | Class II | Ongoing |
| D-0406-2025 | 04-23-2025 | Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15. Package NDCs: 50268-068-15; 50268-068-02 | cGMP deviations and lack of assurance of sterility. | BRS Analytical Services, LLC / 32,876 cases (24 cartons per case) | Class II | Ongoing |
| D-0404-2025 | 04-23-2025 | Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15. Package NDCs: 50268-043-15 | cGMP deviations and lack of assurance of sterility. | BRS Analytical Services, LLC / 13,872 cases (24 cartons per case) | Class II | Ongoing |
| D-0408-2025 | 04-23-2025 | Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15. Package NDCs: 50268-678-15 | cGMP deviations and lack of assurance of sterility. | BRS Analytical Services, LLC / 14,333 cases (24 cartons per case) | Class II | Ongoing |
| D-0407-2025 | 04-23-2025 | Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15. Package NDCs: 50268-126-15 | cGMP deviations and lack of assurance of sterility. | BRS Analytical Services, LLC / 13,104 cases (24 cartons per case) | Class II | Ongoing |
| D-0411-2025 | 04-22-2025 | Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02 | CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets. | RemedyRePack Inc. / 23 bottles/30 count- 690 capsules | Class II | Ongoing |
| D-0390-2025 | 04-21-2025 | Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01 Package NDCs: 55150-429-01; 55150-430-01 | Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances. | Eugia US LLC / | Class II | Ongoing |
| D-0539-2025 | 04-21-2025 | EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02. Package NDCs: 55513-880-01; 55513-880-02; 55513-998-01; 55513-998-02; 55513-509-01; 55513-509-02 | CGMP Deviations; potential temperature excursions due to transit delays | Mckesson Medical-Surgical Inc. Corporate Office / 2 Pre-filled syringes | Class II | Ongoing |
| D-0538-2025 | 04-21-2025 | PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21 Package NDCs: 55513-710-01; 55513-710-21 | CGMP Deviations; potential temperature excursions due to transit delays | Mckesson Medical-Surgical Inc. Corporate Office / 6 Pre-filled syringes | Class II | Ongoing |
| D-0389-2025 | 04-21-2025 | Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01 Package NDCs: 55150-429-01; 55150-430-01 | Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances. | Eugia US LLC / 18,867 bags | Class II | Ongoing |
| D-0540-2025 | 04-21-2025 | BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK. Package NDCs: 49401-102-01; 49401-101-01; 49401-088-42; 49401-088-47; 49401-088-50; 49401-088-01; 49401-088-35; 49401-088-02; 49401-088-61 | CGMP Deviations; potential temperature excursions due to transit delays | Mckesson Medical-Surgical Inc. Corporate Office / 3 Vials | Class II | Ongoing |
| D-0399-2025 | 04-18-2025 | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01] Package NDCs: 0517-0735-01; 0517-0735-10 | Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. | American Regent, Inc. / 7,249 (cartons of 10 x 10 mL vials) | Class II | Ongoing |
| D-0398-2025 | 04-18-2025 | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01. Package NDCs: 72572-470-01; 72572-470-10 | Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. | American Regent, Inc. / 29,777 (cartons of 10 x 10mL vials) | Class II | Ongoing |
| D-0391-2025 | 04-18-2025 | Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03. | cGMP Deviations | Preferred Pharmaceuticals, Inc. / 1190 Bottles | Class II | Ongoing |
| D-0403-2025 | 04-18-2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01. Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15 | Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. | FDC Limited / 60428 bottles | Class II | Ongoing |
| D-0402-2025 | 04-17-2025 | Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box) Package NDCs: 70121-1732-9; 70121-1732-3; 70121-1733-9; 70121-1733-3; 70121-1734-7; 70121-1734-3; 70121-1735-7; 70121-1735-3; 70121-1734-1 | Presence of Particulate Matter | Amneal Pharmaceuticals, LLC / 62 (12x100mL) bags | Class I | Completed |
| D-0381-2025 | 04-15-2025 | Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15 Package NDCs: 55758-409-15 | cGMP deviations | Pharmadel, LLC / 20,048 bottles | Class II | Terminated |
| D-0392-2025 | 04-15-2025 | Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial). | Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025. | Nubratori, Inc / 20 boxes | Class II | Ongoing |
| D-0384-2025 | 04-15-2025 | Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30 | cGMP deviations | Pharmadel, LLC / 10,752 bottles | Class II | Terminated |
| D-0379-2025 | 04-15-2025 | DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15 | cGMP deviations | Pharmadel, LLC / 9504 bottles | Class II | Terminated |
| D-0385-2025 | 04-15-2025 | HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01. | Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification.. | OurPharma LLC / 1,375 cassettes | Class III | Terminated |
| D-0383-2025 | 04-15-2025 | Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99 | cGMP deviations | Pharmadel, LLC / 6,048 bottles | Class II | Terminated |
| D-0380-2025 | 04-15-2025 | DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15 | cGMP deviations | Pharmadel, LLC / 27,648 bottles | Class II | Terminated |
| D-0382-2025 | 04-15-2025 | Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02 | cGMP deviations | Pharmadel, LLC / 6,048 bottles | Class II | Terminated |
| D-0409-2025 | 04-15-2025 | FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25 | Lack of Assurance of Sterility | Apollo Care, LLC / 440 bags | Class II | Ongoing |
| D-0388-2025 | 04-14-2025 | Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922 Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Breckenridge Pharmaceutical, Inc / 343,344 bottles | Class II | Ongoing |
| D-0465-2025 | 04-14-2025 | ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J. | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil. | SAINI TRADE INC / 300 boxes | Class I | Ongoing |
| D-0387-2025 | 04-14-2025 | Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10 Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Breckenridge Pharmaceutical, Inc / 16,473 bottles | Class II | Ongoing |
| D-0466-2025 | 04-14-2025 | ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9. | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. | SAINI TRADE INC / 500 boxes | Class I | Ongoing |
| D-0464-2025 | 04-14-2025 | MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3. | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. | SAINI TRADE INC / 500 boxes | Class I | Ongoing |
| D-0467-2025 | 04-14-2025 | Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH. | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. | SAINI TRADE INC / 300 boxes | Class I | Ongoing |
| D-0463-2025 | 04-14-2025 | Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG. | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. | SAINI TRADE INC / 3000 boxes | Class I | Ongoing |
| D-0366-2025 | 04-14-2025 | ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61 | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 133 cartons | Class II | Ongoing |
| D-0377-2025 | 04-10-2025 | clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01 Package NDCs: 68180-492-01; 68180-492-07; 68180-492-09; 68180-492-06; 68180-493-01; 68180-493-07; 68180-493-09; 68180-493-06; 68180-494-01; 68180-494-07; 68180-494-09; 68180-494-06 | Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study. | Lupin Pharmaceuticals Inc. / 2724 bottles | Class II | Terminated |
| D-0363-2025 | 04-10-2025 | Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01 Package NDCs: 55150-276-01; 55150-277-01; 55150-278-01 | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. | Eugia US LLC / 36,816 vials | Class II | Ongoing |
| D-0396-2025 | 04-10-2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent | ACCORD HEALTHCARE, INC. / 4,885 Bottles | Class II | Ongoing |
| D-0397-2025 | 04-10-2025 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent | ACCORD HEALTHCARE, INC. / 18,984 Bottles | Class II | Ongoing |
| D-0394-2025 | 04-10-2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent | ACCORD HEALTHCARE, INC. / 4,888 Bottles | Class II | Ongoing |
| D-0395-2025 | 04-10-2025 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent | ACCORD HEALTHCARE, INC. / 4,872 Bottles | Class II | Ongoing |
| D-0393-2025 | 04-09-2025 | Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14. | Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released. | Cardinal Health Inc. / 48 Cartons | Class II | Ongoing |
| D-0376-2025 | 04-09-2025 | Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363 | CGMP Deviations | Apipharma / 5,095 cartons | Class II | Ongoing |
| D-0375-2025 | 04-09-2025 | Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318 | CGMP Deviations | Apipharma / 4,218 boxes | Class II | Ongoing |
| D-0361-2025 | 04-03-2025 | chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1 Package NDCs: 70710-1129-1; 70710-1129-2; 70710-1129-4; 70710-1130-1; 70710-1130-2; 70710-1130-4; 70710-1131-1; 70710-1131-2; 70710-1131-4; 70710-1132-1; 70710-1132-2; 70710-1132-4; 70710-1133-1; 70710-1133-2; 70710-1133-4 | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit | Zydus Pharmaceuticals (USA) Inc / 3144 bottles, pack size: 100's Count | Class II | Ongoing |
| D-0369-2025 | 04-02-2025 | Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48. Package NDCs: 68001-579-59; 68001-579-48; 68001-580-41; 68001-581-41; 68001-581-48; 68001-581-82; 68001-578-59; 68001-578-48; 68001-582-41 | Lack of assurance of sterility. Bacterial contamination detected in some media fill units | Amerisource Health Services LLC / 143 1x5 vials | Class II | Ongoing |
| D-0367-2025 | 04-02-2025 | Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41. Package NDCs: 68001-579-59; 68001-579-48; 68001-580-41; 68001-581-41; 68001-581-48; 68001-581-82; 68001-578-59; 68001-578-48; 68001-582-41 | Lack of assurance of sterility. Bacterial contamination detected in some media fill units | Amerisource Health Services LLC / 2,110 vials | Class II | Ongoing |
| D-0368-2025 | 04-02-2025 | Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41. Package NDCs: 68001-579-59; 68001-579-48; 68001-580-41; 68001-581-41; 68001-581-48; 68001-581-82; 68001-578-59; 68001-578-48; 68001-582-41 | Lack of assurance of sterility. Bacterial contamination detected in some media fill units | Amerisource Health Services LLC / 14,189 vials | Class II | Ongoing |
| D-0372-2025 | 03-31-2025 | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11, | Lack of Assurance of Sterility: Leaking/damaged syringes. | Denver Solutions, LLC DBA Leiters Health / 7,290 syringes | Class II | Ongoing |
| D-0371-2025 | 03-31-2025 | dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11. | Lack of Assurance of Sterility: Leaking/damaged syringes. | Denver Solutions, LLC DBA Leiters Health / 23,610 syringes | Class II | Ongoing |
| D-0370-2025 | 03-31-2025 | Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11 | Lack of Assurance of Sterility: Leaking/damaged syringes. | Denver Solutions, LLC DBA Leiters Health / 170 syringes | Class II | Ongoing |
| D-0374-2025 | 03-31-2025 | Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11 | Lack of Assurance of Sterility: Leaking/damaged syringes. | Denver Solutions, LLC DBA Leiters Health / 16,655 syringes | Class II | Ongoing |
| D-0373-2025 | 03-31-2025 | Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11 | Lack of Assurance of Sterility: Leaking/damaged syringes. | Denver Solutions, LLC DBA Leiters Health / 49,830 syringes | Class II | Ongoing |
| D-0353-2025 | 03-31-2025 | 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10 Package NDCs: 0264-2201-00; 0264-2201-10; 0264-2201-50; 0264-2201-70 | Presence of Particulate Matter | B. Braun Medical Inc / 32,256 Bottles | Class II | Ongoing |
| D-0386-2025 | 03-31-2025 | Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY | CGMP Deviations | Medisca Inc. / 161.6 grams | Class II | Terminated |
| D-0308-2025 | 03-26-2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit. | Breckenridge Pharmaceutical, Inc. / 14,863 bottles | Class II | Ongoing |
| D-0362-2025 | 03-26-2025 | Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2 | CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit | Chattem Inc / 129,240 bottles | Class II | Ongoing |
| D-0378-2025 | 03-24-2025 | Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00 | CGMP Deviations | RemedyRepack Inc. / 1,858 30-count blister cards | Class II | Ongoing |
| D-0307-2025 | 03-24-2025 | Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11. Package NDCs: 60687-294-11; 60687-294-21; 60687-273-11; 60687-273-21 | cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product. | Amerisource Health Services LLC / 889 cartons | Class II | Terminated |
| D-0310-2025 | 03-21-2025 | Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01. Package NDCs: 68382-018-06; 68382-018-14; 68382-018-16; 68382-018-01; 68382-018-05; 68382-018-10; 68382-019-06; 68382-019-14; 68382-019-16; 68382-019-01; 68382-019-05; 68382-019-10; 68382-020-06; 68382-020-14; 68382-020-16; 68382-020-01; 68382-020-05; 68382-020-10; 68382-021-06; 68382-021-14; 68382-021-16; 68382-021-01; 68382-021-05; 68382-021-10; 68382-101-06; 68382-101-14; 68382-101-16; 68382-101-01; 68382-101-05; 68382-101-10 | Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet. | Zydus Pharmaceuticals (USA) Inc / 13,128 100-Count Bottles | Class II | Completed |
| D-0358-2025 | 03-21-2025 | Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10 Package NDCs: 70069-030-05; 70069-030-03; 70069-031-01; 70069-031-05; 70069-381-01; 70069-381-10; 70069-382-01; 70069-382-05; 70069-383-05; 70069-383-10; 70069-383-01; 70069-384-01; 70069-384-05 | Lack of Assurance of Sterility: Media fill with bacterial contamination | Somerset Therapeutics Private Limited / 240 vials | Class II | Ongoing |
| D-0356-2025 | 03-21-2025 | Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41 Package NDCs: 68001-579-59; 68001-579-48; 68001-580-41; 68001-581-41; 68001-581-48; 68001-581-82; 68001-578-59; 68001-578-48; 68001-582-41 | Lack of Assurance of Sterility: Media fill with bacterial contamination | Somerset Therapeutics Private Limited / 4956 vials | Class II | Ongoing |
| D-0354-2025 | 03-21-2025 | Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton) Package NDCs: 70069-101-25; 70069-101-10; 70069-101-05 | Lack of Assurance of Sterility: Media fill with bacterial contamination | Somerset Therapeutics Private Limited / 506,080 vials | Class II | Ongoing |
| D-0355-2025 | 03-21-2025 | Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton) Package NDCs: 70069-030-05; 70069-030-03; 70069-031-01; 70069-031-05; 70069-381-01; 70069-381-10; 70069-382-01; 70069-382-05; 70069-383-05; 70069-383-10; 70069-383-01; 70069-384-01; 70069-384-05 | Lack of Assurance of Sterility: Media fill with bacterial contamination | Somerset Therapeutics Private Limited / 997 vials | Class II | Ongoing |
| D-0357-2025 | 03-21-2025 | Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons) Package NDCs: 68001-579-59; 68001-579-48; 68001-580-41; 68001-581-41; 68001-581-48; 68001-581-82; 68001-578-59; 68001-578-48; 68001-582-41 | Lack of Assurance of Sterility: Media fill with bacterial contamination | Somerset Therapeutics Private Limited / 23,960 vials | Class II | Ongoing |
| D-0306-2025 | 03-17-2025 | Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13 Package NDCs: 70377-077-11; 70377-077-13; 70377-077-12; 70377-078-11; 70377-078-13; 70377-078-12; 70377-079-11; 70377-079-12; 70377-079-13; 70377-080-11; 70377-080-12; 70377-080-13 | Failed dissolution specifications: lower than specifications | BIOCON PHARMA INC / 2184 bottles | Class II | Ongoing |
| D-0341-2025 | 03-13-2025 | 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. Package NDCs: 68462-195-90; 68462-195-05; 68462-196-90; 68462-196-05; 68462-197-90; 68462-197-05; 68462-198-90; 68462-198-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0325-2025 | 03-13-2025 | 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. Package NDCs: 68462-195-90; 68462-195-05; 68462-196-90; 68462-196-05; 68462-197-90; 68462-197-05; 68462-198-90; 68462-198-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0330-2025 | 03-13-2025 | 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 Package NDCs: 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 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0352-2025 | 03-13-2025 | 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 Package NDCs: 16714-825-01; 16714-826-01; 16714-827-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0346-2025 | 03-13-2025 | 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 Package NDCs: 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 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0351-2025 | 03-13-2025 | 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. Package NDCs: 16714-825-01; 16714-826-01; 16714-827-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0316-2025 | 03-13-2025 | 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 Package NDCs: 68462-408-60; 68462-409-60; 68462-410-60 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0344-2025 | 03-13-2025 | 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 Package NDCs: 68462-142-01; 68462-143-01; 68462-143-05; 68462-144-01; 68462-144-81 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0327-2025 | 03-13-2025 | 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 Package NDCs: 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 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0331-2025 | 03-13-2025 | 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 Package NDCs: 68462-638-01; 68462-639-01; 68462-639-25; 68462-639-45; 68462-640-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0342-2025 | 03-13-2025 | 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 Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0314-2025 | 03-13-2025 | 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 Package NDCs: 68462-580-01; 68462-581-01; 68462-582-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0315-2025 | 03-13-2025 | 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 Package NDCs: 68462-408-60; 68462-409-60; 68462-410-60 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0317-2025 | 03-13-2025 | 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. Package NDCs: 68462-386-30; 68462-386-90; 68462-386-14; 68462-387-30; 68462-387-90; 68462-387-14 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0328-2025 | 03-13-2025 | 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 | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0347-2025 | 03-13-2025 | 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 Package NDCs: 72657-157-18; 72657-157-36; 72657-157-72; 72657-157-74; 72657-157-76; 72657-157-20; 72657-157-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0348-2025 | 03-13-2025 | Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35 Package NDCs: 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 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
