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Fenofibrate

FDA recalls

4 rows

DateCompany and reasonClass
May 27, 2026Ajanta Pharma USA Inc
CGMP Deviations		Class II · Ongoing
Mar 12, 2025Glenmark Pharmaceuticals Inc., USA
CGMP Deviations		Class II · Ongoing
Mar 14, 2021Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.		Class II · Terminated
Sep 11, 2018Hetero Labs, Ltd. - Unit III
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.		Class III · 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).