Browse Drug Recalls

3,394 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,394 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 3,394 FDA drug recalls.

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DateProductReasonClassFirm
Oct 31, 2025 Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (5... cGMP deviations Class II Blossom Pharmaceuticals
Oct 22, 2025 clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bot... cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... Class II Zydus Pharmaceuticals (USA) Inc
Oct 22, 2025 clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bot... cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... Class II Zydus Pharmaceuticals (USA) Inc
Oct 22, 2025 clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bot... cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... Class II Zydus Pharmaceuticals (USA) Inc
Oct 14, 2025 Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSE... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FO... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, ... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUB... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSER... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERIL... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STER... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERIL... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBC... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 10, 2025 Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottl... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) p... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Ar... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Dis... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g pe... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% an... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 O... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT.... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 9, 2025 Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51... CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. Class II Breckenridge Pharmaceutical, Inc.
Oct 9, 2025 Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it c... Class II Amerisource Health Services LLC
Oct 7, 2025 Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHA... CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... Class II Teva Pharmaceuticals USA, Inc
Oct 7, 2025 Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHA... CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... Class II Teva Pharmaceuticals USA, Inc
Oct 7, 2025 Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHA... CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... Class II Teva Pharmaceuticals USA, Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-58... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-5... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-58... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-58... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-57... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Sep 29, 2025 Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl A... cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol co... Class II Acuity Specialty Products, Inc.
Sep 29, 2025 AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by... cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol co... Class II Acuity Specialty Products, Inc.
Sep 25, 2025 Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, ... cGMP deviations: the firm released and distributed product which failed total aerobic microbial c... Class II SV Labs Prescott Corporation
Sep 23, 2025 Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL b... CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. Class II Park Avenue Compounding
Sep 17, 2025 Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue... CGMP Deviations Class II Park Avenue Compounding
Sep 17, 2025 Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured ... CGMP Deviations: Market complaints received for gritty texture (grainy) Class II Glenmark Pharmaceuticals Inc., USA

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.