Official recall notice

FDA DrugClass IINotable

FDA Recall: Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (ND

Recall date
2026-09-02
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

Product description

Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

Affected products

a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027

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