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Browse Drug Recalls

4 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 4 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 4 FDA drug recalls.

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DateProductReasonClassFirm
Mar 14, 2023 Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx ... CGMP Deviations: Discoloration Class II Hetero USA Inc
Jul 20, 2017 Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for... Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/... Class II Hetero USA Inc
Apr 27, 2017 Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: ... Presence of Foreign Substance: human hair melded into tablet. Class III Hetero USA Inc
Jan 7, 2017 Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for... Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue ... Class III Hetero 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.