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Browse Drug Recalls

15 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 15 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 15 FDA drug recalls.

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DateProductReasonClassFirm
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 30, 2019 Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured fo... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Apr 18, 2015 Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle,... Failed Impurities/Degradation Specifications Class III Valeant Pharmaceuticals North America LLC
Apr 18, 2015 Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100... Failed Impurities/Degradation Specifications Class III Valeant Pharmaceuticals North America LLC
Apr 17, 2015 Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only.... Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time po... Class II Valeant Pharmaceuticals North America LLC
Oct 2, 2014 Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufacture... Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ... Class III Valeant Pharmaceuticals International
Oct 2, 2014 Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, M... Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ... Class III Valeant Pharmaceuticals International
Jun 5, 2014 APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count... Labeling: Incorrect or Missing Package Insert Class III Valeant Pharmaceuticals North America LLC
Jun 5, 2014 APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-co... Labeling: Incorrect or Missing Package Insert Class III Valeant Pharmaceuticals North America LLC
Jun 5, 2014 APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-co... Labeling: Incorrect or Missing Package Insert Class III Valeant Pharmaceuticals North America LLC
May 21, 2014 Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmac... Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... Class III Valeant Pharmaceuticals North America LLC
May 21, 2014 Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-... Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... Class III Valeant Pharmaceuticals North America 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.