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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 12, 2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) ... | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 12, 2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) bli... | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 12, 2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) b... | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 12, 2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) ... | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 12, 2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) ... | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 5, 2025 | Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, ... | cGMP deviations: Temperature excursion during transportation. | Class II | Sandoz Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Aug 27, 2025 | DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in ... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) ... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1),... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) ... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 ... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Indust... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ell... | cGMP violations | Class II | Atlantic Management Resources Ltd. |
| Aug 27, 2025 | DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol ... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, Der... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bo... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g ... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (N... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 20, 2025 | Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Pack... | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Aug 8, 2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, R... | CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Aug 7, 2025 | Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: G... | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 7, 2025 | Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462... | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 7, 2025 | Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by:... | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 6, 2025 | Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured ... | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable... | Class II | Westminster Pharmaceuticals LLC |
| Aug 6, 2025 | Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured... | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable... | Class II | Westminster Pharmaceuticals LLC |
| Aug 6, 2025 | Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactur... | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 6, 2025 | Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured... | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jul 30, 2025 | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech... | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... | Class II | Cardinal Health Inc. |
| Jul 30, 2025 | Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South ... | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... | Class II | Cardinal Health Inc. |
| Jul 30, 2025 | RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Take... | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... | Class II | Cardinal Health Inc. |
| Jul 29, 2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... | CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... | Class II | Amerisource Health Services LLC |
| Jul 25, 2025 | Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactur... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... | Class II | Alembic Pharmaceuticals Limited |
| Jul 25, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, R... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, 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.