Hikma Pharmaceuticals USA Inc.: Ramipril Capsules Usp, 10 Mg
Recall Summary Hikma Pharmaceuticals is recalling Ramipril Capsules USP, 10 mg in bottles of 100 and 500 capsules nationwide because the medication contains higher-than-acceptable levels of a process impurity called dicyclohexylurea (DCU). The affected batches were manufactured by West-Ward Columbus Inc. for Exelan Pharmaceuticals and distributed throughout the United States.
- Recalling firm
- 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), Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
- Reason
- Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-24
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/32455943-df82-4c6d-8d32-7710c7a1dd6e