Class IIDrugOngoing

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, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.

Reason for recall

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

Details

Recall number: D-0831-2026
Event ID: 99711
Recall initiated: Aug 24, 2026
Classified: Sep 3, 2026
Reported: Sep 2, 2026
Quantity: a) 25,970 bottles; b) 2,384 bottles
Distribution: Nationwide within the United States
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Columbus, OH, United States
Lot / code info: a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027