Browse Drug Recalls
14,136 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,136 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 14,136 FDA drug recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by:... | Superpotent drug | Class II | Ascend Laboratories, 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 | 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 |
| Aug 27, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack pe... | 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 | 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 | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, R... | 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 | 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 | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack pe... | 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 | 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 26, 2025 | STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Beth... | Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. | Class II | B BRAUN MEDICAL INC |
| Aug 26, 2025 | 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL... | Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. | Class II | B BRAUN MEDICAL INC |
| Aug 25, 2025 | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit do... | Presence of a foreign substance. | Class II | AvKARE |
| Aug 25, 2025 | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dos... | Presence of a foreign substance. | Class II | AvKARE |
| Aug 22, 2025 | Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide... | Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF res... | Class II | GRACE & FIRE PTY LTD |
| Aug 22, 2025 | Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Min... | Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF res... | Class II | GRACE & FIRE PTY LTD |
| Aug 20, 2025 | Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength ... | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product pack... | Class II | Northwind Pharmaceuticals 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 20, 2025 | Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo ... | Discoloration | Class II | Baxter Healthcare Corporation |
| Aug 19, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amph... | Class II | Lannett Company Inc. |
| Aug 18, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, ... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amneal Pharmaceuticals, 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.