Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Sep 19, 2025 Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-... Failed Dissolution Specifications Class II Ascend Laboratories, LLC
Sep 19, 2025 Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-... Failed Dissolution Specifications Class II Ascend Laboratories, LLC
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
Sep 16, 2025 Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, ... Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the... Class II ACCORD HEALTHCARE, INC.
Sep 16, 2025 Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only... Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. Class I IntegraDose Compounding Services LLC
Sep 15, 2025 Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x... Failed Dissolution Specifications. Class II Amerisource Health Services LLC
Sep 15, 2025 Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count b... Failed Tablet/Capsule Specifications Class II Graviti Pharmaceuticals Private Limited
Sep 12, 2025 Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl P... 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 Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured... Tablet/Capsules Imprinted with Wrong ID Class III JB Chemicals and Pharmaceuticals Ltd
Sep 12, 2025 Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7... 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 Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 ... 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 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 mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Sk... 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 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 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.

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.