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Ezetimibe/Simvastatin

FDA recalls

6 rows

DateCompany and reasonClass
May 18, 2025Glenmark Pharmaceuticals Inc., USA
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.		Class III · Ongoing
Oct 13, 2021Golden State Medical Supply Inc.
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity		Class II · Terminated
Oct 13, 2021Golden State Medical Supply Inc.
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle		Class II · Terminated
Oct 4, 2021Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle		Class II · Terminated
Oct 4, 2021Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity		Class II · Terminated
Mar 14, 2021Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.		Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).