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-0349-2025 | 03-13-2025 | 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 | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0339-2025 | 03-13-2025 | 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 Package NDCs: 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 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0350-2025 | 03-13-2025 | 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 | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0365-2025 | 03-13-2025 | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52 Package NDCs: 43598-635-52; 43598-635-10; 43598-636-52; 43598-636-10; 43598-637-52; 43598-637-10 | LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. | Dr. Reddy's Laboratories, Inc. / 4,010 bags | Class I | Ongoing |
| D-0322-2025 | 03-13-2025 | 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 Package NDCs: 68462-694-97 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0345-2025 | 03-13-2025 | 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. Package NDCs: 68462-726-30; 68462-726-90; 68462-726-05; 68462-727-30; 68462-727-90; 68462-727-05; 68462-727-14 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0340-2025 | 03-13-2025 | 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 Package NDCs: 68462-433-90; 68462-433-18 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0332-2025 | 03-13-2025 | 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. Package NDCs: 68462-726-30; 68462-726-90; 68462-726-05; 68462-727-30; 68462-727-90; 68462-727-05; 68462-727-14 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0326-2025 | 03-13-2025 | 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 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-0329-2025 | 03-13-2025 | 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 Package NDCs: 68462-325-60; 68462-325-90; 68462-325-01; 68462-325-05; 68462-325-10 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0336-2025 | 03-13-2025 | 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. Package NDCs: 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 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0323-2025 | 03-13-2025 | 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 Package NDCs: 68462-713-30; 68462-713-08; 68462-713-05; 68462-714-08; 68462-714-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0334-2025 | 03-13-2025 | 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 Package NDCs: 68462-423-15; 68462-423-85; 68462-423-30; 68462-424-15; 68462-424-85; 68462-424-30 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0320-2025 | 03-13-2025 | 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. Package NDCs: 68462-126-01; 68462-126-05; 68462-127-01; 68462-127-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0333-2025 | 03-13-2025 | 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. 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-0335-2025 | 03-13-2025 | 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 Package NDCs: 68462-319-60; 68462-319-05; 68462-320-60; 68462-320-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0324-2025 | 03-13-2025 | 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. 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-0319-2025 | 03-13-2025 | 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. Package NDCs: 68462-572-30; 68462-572-90; 68462-572-13; 68462-573-30; 68462-573-90; 68462-573-13 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0343-2025 | 03-13-2025 | 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. 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-0321-2025 | 03-13-2025 | 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. 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-0337-2025 | 03-13-2025 | 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 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-0318-2025 | 03-13-2025 | 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 Package NDCs: 68462-572-30; 68462-572-90; 68462-572-13; 68462-573-30; 68462-573-90; 68462-573-13 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0338-2025 | 03-13-2025 | 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 | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0512-2025 | 03-12-2025 | B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c) Tan Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1003-2. | cGMP deviations | KABANA SKIN CARE / 204 tubes | Class II | Ongoing |
| D-0360-2025 | 03-12-2025 | Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b) 0.33 OZ (9.45g), UPC 8 42944 10223 1; Distributed by Alchemee, LLC, Santa Monica, CA 90401, | Chemical contamination: Presence of benzene | Alchemee, LLC / 3,500 bottles | Class II | Ongoing |
| D-0514-2025 | 03-12-2025 | GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1 | cGMP deviations | KABANA SKIN CARE / 174 tubes | Class II | Ongoing |
| D-0359-2025 | 03-12-2025 | Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 10223 1, and also packaged as a twin pack UPC 8 42944 10241 5, | Chemical contamination: Presence of benzene | Alchemee, LLC / 38,237 bottles | Class II | Ongoing |
| D-0513-2025 | 03-12-2025 | Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1 | cGMP deviations | KABANA SKIN CARE / 54 tubes | Class II | Ongoing |
| D-0515-2025 | 03-12-2025 | In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL - 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin Care, Belleair Bluffs, FL, Made in USA, NDC: 73369-1601-1 | cGMP deviations | KABANA SKIN CARE / 76 bottles | Class II | Ongoing |
| D-0309-2025 | 03-11-2025 | chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01 Package NDCs: 68462-861-01; 68462-861-10; 68462-862-01; 68462-862-10; 68462-863-01; 68462-863-10; 68462-864-01; 68462-864-10; 68462-865-01; 68462-865-10 | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 8160 bottles | Class II | Ongoing |
| D-0284-2025 | 03-11-2025 | CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc | Chemical contamination: presence of benzene | Fruit Of The Earth, Inc. / 112045 tubes | Class II | Ongoing |
| D-0283-2025 | 03-11-2025 | Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015 | Chemical contamination: presence of benzene | Fruit Of The Earth, Inc. / 100,970 tubes | Class II | Ongoing |
| D-0282-2025 | 03-11-2025 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05 Package NDCs: 69315-308-02; 69315-308-05; 69315-308-10 | 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 / 90960 bottles | Class II | Ongoing |
| D-0291-2025 | 03-07-2025 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20. Package NDCs: 51079-440-01; 51079-440-20; 51079-444-01; 51079-444-20; 51079-441-01; 51079-441-20; 51079-442-01; 51079-442-20; 51079-443-01; 51079-443-20; 51079-445-01; 51079-445-20 | Super-Potent Drug: Out of specification potency results were obtained. | Mylan Institutional, Inc. / 1,068 cartons | Class II | Ongoing |
| D-0568-2025 | 03-07-2025 | Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Direct Rx / 875 bottles | Class II | Ongoing |
| D-0290-2025 | 03-07-2025 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20. Package NDCs: 51079-440-01; 51079-440-20; 51079-444-01; 51079-444-20; 51079-441-01; 51079-441-20; 51079-442-01; 51079-442-20; 51079-443-01; 51079-443-20; 51079-445-01; 51079-445-20 | Super-Potent Drug: Out of specification potency results were obtained. | Mylan Institutional, Inc. / 347 Cartons | Class II | Ongoing |
| D-0302-2025 | 03-07-2025 | [CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109. | Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol | Consumer Product Partners, LLC / 25,932 bottles | Class II | Ongoing |
| D-0313-2025 | 03-07-2025 | Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72626-2701-1 Package NDCs: 72626-2701-1 | Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton. | ASEGUA THERAPEUTICS LLC / 18,541 cartons. | Class II | Terminated |
| D-0278-2025 | 03-07-2025 | Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04 | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. | Slate Run Pharmaceuticals / 56,790 bottles | Class II | Completed |
| D-0279-2025 | 03-07-2025 | Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04 | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. | Slate Run Pharmaceuticals / 2,444 bottles | Class II | Completed |
| D-0567-2025 | 03-07-2025 | Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Direct Rx / 16 bottles | Class II | Ongoing |
| D-0303-2025 | 03-07-2025 | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4 Package NDCs: 51754-5001-5; 51754-5001-4; 51754-5011-4; 51754-5002-5; 51754-5012-4; 51754-5001-1 | Lack of Assurance of Sterility | Exela Pharma Sciences LLC / 103,950 vials | Class II | Ongoing |
| D-0297-2025 | 03-06-2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75 | Lack of Assurance of Sterility | QuVa Pharma, Inc. / 1,765 cassettes | Class II | Ongoing |
| D-0296-2025 | 03-06-2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75 | Lack of Assurance of Sterility | QuVa Pharma, Inc. / 2,310 cassettes | Class II | Ongoing |
| D-0295-2025 | 03-06-2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75 | Lack of Assurance of Sterility | QuVa Pharma, Inc. / N/A | Class II | Ongoing |
| D-0287-2025 | 03-05-2025 | PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30 Package NDCs: 51407-444-30; 51407-445-30 | Failed Dissolution Specifications | Golden State Medical Supply Inc. / 2,601 30-count bottles | Class II | Ongoing |
| D-0293-2025 | 03-05-2025 | Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02 Package NDCs: 64380-152-01; 64380-152-02; 64380-151-01; 64380-151-02 | Presence of foreign substance: Presence of Benzene. | Strides Pharma, Inc. / 195,952 Cartons; 30 sachets/Carton. | Class II | Ongoing |
| D-0277-2025 | 03-05-2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Rising Pharma Holding, Inc. / 1223 bottles | Class II | Ongoing |
| D-0419-2025 | 03-05-2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France. | cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots. | L'Oreal USA / | Class II | Ongoing |
| D-0417-2025 | 03-05-2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, Laboratoire Dermatologique, CAI 86270, La Roche-Posay, France, UPC 883140500759. | Chemical Contamination: This recall has been initiated due to detected trace levels of benzene. | L'Oreal USA / 2,226,801 bottles | Class II | Ongoing |
| D-0418-2025 | 03-05-2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz. (100 mL) Tube, Clarifying Solution 3.4 fl. oz. (100 mL) Tube, Dual Action Acne Treatment 0.7 fl. oz. (20 mL: UPC 883140035275) Tube, (benzoyl peroxide 0.5% and benzoyl peroxide 5.5% and salicylic acid 2%), La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France, UPC 883140035282 (kit). | cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots. | L'Oreal USA / 14,460 bottles | Class II | Ongoing |
| D-0294-2025 | 03-05-2025 | Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02 Package NDCs: 64380-152-01; 64380-152-02; 64380-151-01; 64380-151-02 | Presence of foreign substance: Presence of Benzene. | Strides Pharma, Inc. / 244,412 Cartons; 30 sachets /Carton | Class II | Ongoing |
| D-0266-2025 | 03-04-2025 | Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0 | CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration. | Chattem Inc / 180,696 cartons | Class II | Ongoing |
| D-0304-2025 | 03-04-2025 | Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04. | Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 224 cartons | Class III | Terminated |
| D-0311-2025 | 03-04-2025 | Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. Package NDCs: 62756-137-02; 62756-137-03; 62756-137-05; 62756-137-04; 62756-137-01; 62756-138-02; 62756-138-03; 62756-138-05; 62756-138-04; 62756-138-01; 62756-139-02; 62756-139-03; 62756-139-05; 62756-139-04; 62756-139-01; 62756-202-01; 62756-202-03; 62756-204-01; 62756-204-03 | Cross Contamination | SUN PHARMACEUTICAL INDUSTRIES INC / 12,876 bottles | Class III | Ongoing |
| D-0312-2025 | 03-04-2025 | Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. Package NDCs: 62756-137-02; 62756-137-03; 62756-137-05; 62756-137-04; 62756-137-01; 62756-138-02; 62756-138-03; 62756-138-05; 62756-138-04; 62756-138-01; 62756-139-02; 62756-139-03; 62756-139-05; 62756-139-04; 62756-139-01; 62756-202-01; 62756-202-03; 62756-204-01; 62756-204-03 | Cross Contamination | SUN PHARMACEUTICAL INDUSTRIES INC / 852 bottles | Class III | Ongoing |
| D-0448-2025 | 02-28-2025 | Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. Package NDCs: 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 | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit | Glenmark Pharmaceuticals Inc., USA / [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles | Class II | Ongoing |
| D-0451-2025 | 02-28-2025 | Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05. Package NDCs: 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 | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit | Glenmark Pharmaceuticals Inc., USA / 18,696 bottles | Class II | Ongoing |
| D-0449-2025 | 02-28-2025 | Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. Package NDCs: 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 | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit | Glenmark Pharmaceuticals Inc., USA / [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles | Class II | Ongoing |
| D-0450-2025 | 02-28-2025 | Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05 Package NDCs: 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 | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit | Glenmark Pharmaceuticals Inc., USA / 84,048 bottles | Class II | Ongoing |
| D-0271-2025 | 02-28-2025 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05 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 N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc. / 11,125 bottles. | Class II | Ongoing |
| D-0274-2025 | 02-28-2025 | Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8 | Chemical Contamination: Presence of benzene | Sigan Industries Group Inc. / 13,440 tubes | Class II | Ongoing |
| D-0269-2025 | 02-28-2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, 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 N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc. / 11,100 bottles. | Class II | Ongoing |
| D-0270-2025 | 02-28-2025 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley 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 N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc. / 14,749 bottles. | Class II | Ongoing |
| D-0285-2025 | 02-27-2025 | Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box). Package NDCs: 55513-530-01; 55513-530-10; 55513-530-20; 55513-546-01; 55513-546-10; 55513-546-20; 55513-924-01; 55513-924-10; 55513-924-91; 55513-924-20; 55513-209-01; 55513-209-10; 55513-209-91; 55513-209-20 | Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. | Amgen, Inc. / 313,620 Vials | Class II | Ongoing |
| D-0286-2025 | 02-27-2025 | Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box). Package NDCs: 55513-530-01; 55513-530-10; 55513-530-20; 55513-546-01; 55513-546-10; 55513-546-20; 55513-924-01; 55513-924-10; 55513-924-91; 55513-924-20; 55513-209-01; 55513-209-10; 55513-209-91; 55513-209-20 | Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. | Amgen, Inc. / 258,750 Vials | Class II | Ongoing |
| D-0280-2025 | 02-25-2025 | Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93 Package NDCs: 0378-5185-93; 0378-5186-93 | Failed Dissolution Specifications - low dissolution results | MYLAN PHARMACEUTICALS INC / N/A | Class II | Ongoing |
| D-0292-2025 | 02-25-2025 | METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3. Package NDCs: 50090-1494-3; 50090-1494-4; 50090-1494-0; 50090-1494-1; 50090-1494-2 | Presence of Foreign Tablets/Capsules. | A-S Medication Solutions LLC / 411 180-count bottles | Class II | Ongoing |
| D-0258-2025 | 02-24-2025 | Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case Package NDCs: 66869-104-90; 66869-204-90; 66869-204-07; 66869-404-90; 66869-404-07 | Presence of foreign tablets/capsules | Kowa Pharmaceuticals America / 5,328 Bottles | Class III | Completed |
| D-0273-2025 | 02-24-2025 | Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1 Package NDCs: 71687-0011-1 | Chemical Contamination: Presence of benzene. | Denison Pharmaceuticals, LLC / 642,131 tubes | Class II | Ongoing |
| D-0305-2025 | 02-24-2025 | Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05. | Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim. | Imprimis NJOF, LLC / 2822 bottles | Class III | Ongoing |
| D-0272-2025 | 02-20-2025 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1. | Presence of Particulate Matter | Central Admixture Pharmacy Services, Inc. / 1546 bags | Class I | Ongoing |
| D-0281-2025 | 02-20-2025 | Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency. | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil. | One Source Nutrition, Inc, / a) 300 individually wrapped capsules b) 20 bottles | Class I | Ongoing |
| D-0248-2025 | 02-18-2025 | Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01. | Lack of Assurance of Sterility: due to a quality control process deviation | Turbare Manufacturing / 1,147 syringes | Class II | Completed |
| D-0289-2025 | 02-17-2025 | CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30. Package NDCs: 53329-827-60; 53329-827-36; 53329-827-30; 53329-827-29; 53329-827-40; 53329-827-09; 53329-827-33; 6122405000 | Subpotent Drug | MEDLINE INDUSTRIES, LP - Northfield / 1,639,996 pads | Class II | Ongoing |
| D-0250-2025 | 02-17-2025 | Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302. | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC / 3069 Oral Syringes | Class II | Ongoing |
| D-0288-2025 | 02-17-2025 | Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30. Package NDCs: 53329-811-30; 53329-811-09; 6122404005 | Subpotent Drug | MEDLINE INDUSTRIES, LP - Northfield / 6,669,874 pads | Class II | Ongoing |
| D-0252-2025 | 02-17-2025 | Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059. | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC / 1535 Oral Syringes | Class II | Ongoing |
| D-0253-2025 | 02-17-2025 | Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784. | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC / 3465 Oral Syringes | Class II | Ongoing |
| D-0254-2025 | 02-17-2025 | Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750. | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC / 12390 Oral Syringes | Class II | Ongoing |
| D-0251-2025 | 02-17-2025 | Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375. | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC / 10992 Oral Syringes | Class II | Ongoing |
| D-0259-2025 | 02-14-2025 | BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31. Package NDCs: 54365-400-31 | Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. | CareFusion 213, LLC / 205,440 applicators | Class I | Ongoing |
| D-0255-2025 | 02-13-2025 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ Package NDCs: 70710-1726-1; 70710-1726-8 | Failed Impurities/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc / 36,978 vials | Class II | Ongoing |
| D-0276-2025 | 02-13-2025 | Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916 | Chemical Contamination | Johnson, S C and Son, Inc / 493,462 units | Class II | Ongoing |
| D-0268-2025 | 02-13-2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269 Package NDCs: 0990-7074-26; 0990-7075-14; 0990-7075-26; 0990-7077-14; 0990-7077-26; 0030990707 | Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq | ICU Medical, Inc. / unknown | Class I | Ongoing |
| D-0267-2025 | 02-13-2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267 Package NDCs: 0990-7074-26; 0990-7075-14; 0990-7075-26; 0990-7077-14; 0990-7077-26; 0030990707; 3030990707 | Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container. | ICU Medical, Inc. / 67,488 flexible containers | Class I | Ongoing |
| D-0275-2025 | 02-13-2025 | Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403. | Chemical Contamination | Johnson, S C and Son, Inc / 449,502 units | Class II | Ongoing |
| D-0256-2025 | 02-13-2025 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ Package NDCs: 70710-1839-1; 70710-1839-8 | Failed Impurities/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc / 1,893 vials | Class II | Ongoing |
| D-0622-2025 | 02-13-2025 | Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distributed by: Essential Products, www.essentialproductsusa.com, NDC: 70242-109-01 | Defective Container: broken or leaking bottles. | World Perfumes Inc. / 3,900 bottles | Class II | Ongoing |
| D-0247-2025 | 02-12-2025 | ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01. | Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. | Wuxi Medical lnstrument Factory Co., Ltd. / 37,500 Boxes | Class II | Ongoing |
| D-0257-2025 | 02-10-2025 | Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50 | Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port. | Nephron Sterile Compounding Center LLC / 4,190 bottles | Class II | Terminated |
| D-0265-2025 | 02-07-2025 | Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. / 4.0 kg | Class II | Ongoing |
| D-0261-2025 | 02-07-2025 | Alprostadil Container Description: Amber color bottle | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. / 3.0 gm | Class II | Ongoing |
| D-0264-2025 | 02-07-2025 | Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. / 150.0 gm | Class II | Ongoing |
| D-0262-2025 | 02-07-2025 | Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. / 120.0 kg | Class II | Ongoing |
| D-0263-2025 | 02-07-2025 | Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. / 5.1 kg | Class II | Ongoing |
| D-0260-2025 | 02-07-2025 | Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. / 400.0 gm | Class II | Ongoing |
| D-0249-2025 | 02-06-2025 | Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01 Package NDCs: 63304-450-03; 63304-450-01; 63304-450-05; 63304-451-03; 63304-451-01; 63304-451-05; 63304-758-03; 63304-758-01; 63304-758-05; 63304-758-50; 63304-452-03; 63304-452-01; 63304-452-05; 63304-453-03; 63304-453-01; 63304-453-05 | Failed Dissolution Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 9840 bottles | Class II | Ongoing |
| D-0246-2025 | 02-06-2025 | Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30 | Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. | Padagis US LLC / 4944 cartons | Class II | Completed |
| D-0229-2025 | 02-04-2025 | Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90 Package NDCs: 42291-777-30; 42291-778-90 | Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%) | AvKARE / 1266 bottles | Class II | Ongoing |
