Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 14, 2025 | Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | Cipla USA, Inc. |
| Nov 14, 2025 | Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | Cipla USA, Inc. |
| Oct 31, 2025 | WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Co... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for:... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Di... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals,... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Tri... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Niv... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Gle... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporatio... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dyn... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnar... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protect... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| 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 |
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.