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Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
Aug 6, 2018 Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, ... Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... Class II Teva Pharmaceuticals USA
May 24, 2017 Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distri... Failed Dissolution Specifications: Low dissolution results were obtained during stability testing Class III Shionogi Inc.
May 24, 2017 Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed b... Presence of foreign substance: The recall was initiated due to black particles being observed whi... Class III Shionogi Inc.
May 24, 2017 PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Man... Failed Dissolution Specifications: Low dissolution results were obtained during stability testing Class III Shionogi Inc.
Jul 24, 2015 Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipi... Failed Dissolution Specifications Class III Shionogi Inc.
Mar 8, 2012 Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manuf... Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month tim... Class II Shionogi 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.