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
Sep 26, 2019 Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial.... Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed ... Class II Alkermes, Inc.
Aug 8, 2019 Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial.... Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed... Class II Alkermes Inc
Mar 4, 2014 VIVITROL (naltrexone for extended-release injectable suspension); 380 mg via... Customer complaints for failure to deliver the dose. Class II Alkermes, Inc.
Nov 6, 2012 VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vi... Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity... Class II Alkermes, 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.