Browse Drug Recalls

17,897 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,897 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 17,897 FDA drug recalls.

DateProductReasonClassFirm
Jul 17, 2018 Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II RemedyRepack Inc.
Jul 17, 2018 Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochloroth... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II A-S Medication Solutions LLC.
Jul 17, 2018 Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II A-S Medication Solutions LLC.
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, U... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Ma... API material used in the manufacturing of the product did not receive regulatory approval prior t... Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bo... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, U... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 13, 2018 Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only M... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Ta... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Ta... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tab... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tabl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tabl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only M... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 12, 2018 Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distr... Presence of Particulate Matter: organic and inorganic compounds detected in vials of product. Class II Sun Pharmaceutical Industries, Inc.
Jul 11, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 20... Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodiu... Class III Renaissance Lakewood, LLC
Jul 11, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... Failed Stability Specifications: lot out of specification for elevated water vapor. Class III Renaissance Lakewood, LLC
Jul 11, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay. Class III Renaissance Lakewood, LLC
Jul 10, 2018 Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dos... Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or e... Class III Valeant Pharmaceuticals North America LLC
Jul 9, 2018 Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bot... Subpotent Drug Class III Mylan Pharmaceuticals Inc.
Jul 5, 2018 alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9... Incorrect Product Formulation: wrong sunscreen product in the package. Class II The Hain Celestial Group, Inc. - Worldwide HQ
Jul 5, 2018 Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection,... Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature. Class II Sanofi-Aventis U.S. LLC
Jul 5, 2018 Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, ... Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) t... Class II Teva Pharmaceuticals USA
Jul 3, 2018 Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL),... CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a... Class II Medi-Fare Drug and Home Health Center
Jul 3, 2018 Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a ... Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, ... Class II Sun Pharmaceutical Industries, Inc.
Jul 3, 2018 Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application... CGMP Deviations: The manufacturer of this product recalled because they were not manufactured und... Class II Medgyn Products, Inc.
Jul 2, 2018 Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Do... Presence of Particulate Matter: identified as glass and silicone material Class I AuroMedics Pharma LLC
Jun 29, 2018 Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic ... Subpotent Drug: Stability data does not support the current expiration dating of 55 days after co... Class II SCA Pharmaceuticals
Jun 29, 2018 Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 m... Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 ... Class I Fagron Compounding Services LLC dba Fagron Ster...
Jun 29, 2018 Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 m... Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 ... Class I Fagron Compounding Services LLC dba Fagron Ster...
Jun 28, 2018 Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufac... Subpotent Drug and Failed Content Uniformity. Class II LUPIN SOMERSET
Jun 28, 2018 Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per... Microbial Contamination of Sterile Products: Product associated with reports of adverse events in... Class II PFIZER
Jun 27, 2018 Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Ph... Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... Class III Aidarex Pharmaceuticals LLC
Jun 27, 2018 Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex ... Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... Class III Aidarex Pharmaceuticals LLC
Jun 27, 2018 Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Ph... Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... Class III Aidarex Pharmaceuticals LLC
Jun 26, 2018 Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid ... Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its p... Class I World Organix, LLC
Jun 26, 2018 Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged... Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its p... Class I World Organix, LLC
Jun 26, 2018 Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in Wh... Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its p... Class I World Organix, LLC
Jun 26, 2018 Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per c... Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... Class III MAJOR PHARMACEUTICALS
Jun 26, 2018 Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per car... Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... Class III MAJOR PHARMACEUTICALS
Jun 26, 2018 Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count pac... Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its p... Class I World Organix, LLC
Jun 26, 2018 Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle.... Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its p... Class I World Organix, 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.