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Browse Drug Recalls

3 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3 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 3 FDA drug recalls.

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DateProductReasonClassFirm
Apr 24, 2017 Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count... Microbial Contamination of Non-Sterile Products Class II Teva Pharmaceuticals USA
Nov 19, 2015 NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industri... Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles. Class III Teva Pharmaceuticals USA
Oct 20, 2015 Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bott... Labeling: Incorrect or Missing Lot AND/OR Exp Date. Class III Teva Pharmaceutical Industries

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.