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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Aug 29, 2019 Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical ... cGMP Deviations: Potential glass contamination Class II Johnson Matthey Inc.
Aug 29, 2019 Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Ma... cGMP Deviations: Potential glass contamination Class II Johnson Matthey Inc.
Aug 29, 2019 Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceut... cGMP Deviations: Potential glass contamination Class II Johnson Matthey Inc.
Apr 2, 2019 Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, pr... Failed Impurities/Degradation Specifications: Unknown impurity above specification limits. Class III Johnson Matthey Inc.
Mar 5, 2018 Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johns... Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morph... Class II Johnson Matthey 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.