Browse Drug Recalls
17,709 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,709 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 17,709 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 12, 2025 | Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 | Labeling: Not Elsewhere Classified | Class III | Letco Medical LLC |
| Sep 12, 2025 | Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured... | Tablet/Capsules Imprinted with Wrong ID | Class III | JB Chemicals and Pharmaceuticals Ltd |
| Sep 12, 2025 | ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverl... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) ... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 5, 2025 | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips wit... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| 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 5, 2025 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Man... | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... | Class II | Apotex Corp. |
| Sep 5, 2025 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL ... | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... | Class II | Apotex Corp. |
| Sep 4, 2025 | Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus L... | Failed Impurity/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 4, 2025 | Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lif... | Failed Impurity/Degradation Specifications | 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 | Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl... | Failed Impurities/Degradation Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| 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 | Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufacture... | Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium T... | Class II | SUN PHARMACEUTICAL INDUSTRIES 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 |
| Sep 2, 2025 | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 T... | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product pack... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 2, 2025 | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Ta... | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product pack... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 2, 2025 | Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0... | Failed Content Uniformity Specifications | Class II | AvKARE |
| Aug 29, 2025 | bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single... | Lack of Assurance of Sterility | Class II | Fagron Compounding Services |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by:... | Superpotent drug | Class II | Ascend Laboratories, LLC |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count... | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil | Class I | Green Lumber Holdings, LLC |
| 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 | Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, ... | Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were... | Class I | Unichem Pharmaceuticals USA Inc. |
| Aug 27, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) bl... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amerisource Health Services 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 | Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 ... | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| 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 |
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.