Hikma Pharmaceuticals USA INC. recalls Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bott
Recalled September 2, 2026 · FDA recall D-0831-2026 · Hikma Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). · FDA Class II
Units
a) 25,970 bottles; b) 2,384 bottles
Sold at
Nationwide within the United States
Description
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
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.
Manufacturer(s)
Hikma Pharmaceuticals USA INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →