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Browse Drug Recalls

57 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 57 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 57 FDA drug recalls.

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DateProductReasonClassFirm
Oct 27, 2020 Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count c... Failed Dissolution Specification Class II Zydus Pharmaceuticals (USA) Inc
Jan 31, 2020 Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, ... cGMP Deviations Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila ... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
Apr 25, 2019 Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by:... Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg act... Class II Zydus Pharmaceuticals USA Inc
Apr 25, 2019 Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: C... Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg act... Class II Zydus Pharmaceuticals USA Inc
Apr 22, 2019 Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by... Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substan... Class III Zydus Pharmaceuticals USA 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.