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Ramipril

FDA recalls

2 rows

DateCompany and reasonClass
Aug 23, 2026Hikma Pharmaceuticals USA Inc.
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Class II · Ongoing
Oct 22, 2024Lupin Pharmaceuticals Inc.
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
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).