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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Feb 9, 2024 Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076... Failed Dissolution Specifications: results slightly under spec at at 9-months. Class III Stason Pharmaceuticals, Inc.
Feb 19, 2019 Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05)... Failed dissolution specifications Class III Amerigen Pharmaceuticals Inc.
Dec 20, 2018 Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and... Failed Dissolution Specifications Class III Amerigen Pharmaceuticals Inc.
Dec 20, 2018 Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, ... Failed Dissolution Specifications Class III Amerigen Pharmaceuticals Inc.
Oct 5, 2018 Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05)... Failed dissolution specifications: Out-of-Specification dissolution results obtained during stabi... Class III Amerigen Pharmaceuticals Inc.
Aug 23, 2016 Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: ... Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out... Class III Stason Pharmaceuticals, Inc.
Oct 22, 2014 Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) ... Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... Class II Prometheus Laboratories 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.