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Browse Drug Recalls

75 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 75 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 75 FDA drug recalls.

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DateProductReasonClassFirm
Mar 5, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tabl... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified Class II AVKARE Inc.
Mar 5, 2019 Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx On... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified Class II AVKARE Inc.
Mar 5, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tab... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified Class II AVKARE Inc.
Mar 1, 2019 Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 4... Failed Dissolution Specifications Class III AVKARE Inc.
Nov 20, 2018 Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./... Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product Class II AVKARE Inc.
Aug 14, 2018 Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-78... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II AVKARE Inc.
Aug 14, 2018 Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-78... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II AVKARE Inc.
Aug 14, 2018 Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-7... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II AVKARE Inc.
Aug 14, 2018 Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II AVKARE Inc.
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bott... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bot... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bot... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Mar 30, 2018 Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only,... Failed Dissolution Specifications Class II AVKARE Inc.
Feb 9, 2018 Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 5... Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Tors... Class II Apace KY LLC
Jan 3, 2018 Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, M... Failed Dissolution Specifications: Low out of specification results for dissolution during annual... Class II AVKARE Inc.
Oct 6, 2017 Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dos... Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid. Class II AVKARE Inc.
Jul 19, 2017 Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Ma... Failed impurities/degradation specifications: Out of specification for a related compound C. Class III AVKARE Inc.
Jun 19, 2017 Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, ... Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blist... Class II Apace KY LLC
Jun 19, 2017 Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose ... Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blist... Class II Apace KY LLC
Feb 15, 2017 Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only,... Failed impurities/ degradation specifications: Product was above specification for unknown impuri... Class II AVKARE Inc.
Feb 12, 2016 Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Do... Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with a... Class III Apace KY LLC
Feb 27, 2015 Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Man... Subpotent Drug Class III AVKARE Inc.
Feb 27, 2015 Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Ma... Subpotent Drug Class III AVKARE 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.