United StatesRamipril Capsules USP, 10 mg, in 100‑capsule bottles (NDC 76282-673-01, Lot AC5470A, exp. July 2027) and 500‑capsule bottles (NDC 76282-673-05, Lot AC5470B, exp. July 2027), manufactured for Exelan Pharmaceuticals and made by West‑Ward Columbus, are affected. They were recalled because an out-of-specification result was obtained for a process impurity, dicyclohexylurea (DCU); the recall is ongoing and covers product sold nationwide in the United States.
What's being recalled
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.
Recalling firm: Hikma Pharmaceuticals USA INC., Columbus, OH, United States.
How to identify it
a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
The hazard
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)