⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Hikma Pharmaceuticals USA INC.: Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufa

DrugsSource: FDA (drug) · Date: 2026-09-02

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Hikma Pharmaceuticals USA INC.
Product
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
Reason / hazard
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2026-08-24
Code info
a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
Product quantity
a) 25,970 bottles; b) 2,384 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Columbus
State
OH
Country
United States
Event id
99711
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