Drug recall D-0831-2026
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 for recall
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Lots and codes
a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
Recall details
- Recalling firm
- Hikma Pharmaceuticals USA INC., Columbus, OH
- Quantity
- a) 25,970 bottles; b) 2,384 bottles
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 24, 2026
Related products
- Ramipril – drug information
- NDC 76282-670 Ramipril · Ramipril 1.25 mg/1 · Exelan Pharmaceuticals, Inc.
- NDC 76282-672 Ramipril · Ramipril 5 mg/1 · Exelan Pharmaceuticals, Inc.
- NDC 76282-673 Ramipril · Ramipril 10 mg/1 · Exelan Pharmaceuticals, Inc.
- NDC 76282-671 Ramipril · Ramipril 2.5 mg/1 · Exelan Pharmaceuticals, Inc.