D-0831-2026 Class II Ongoing
FDA drug recall D-0831-2026 was initiated by Hikma Pharmaceuticals USA INC. on August 24, 2026 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). The recall status is ongoing. Affected quantity: a) 25,970 bottles; b) 2,384 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 2, 2026
- Initiation Date
- August 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 25,970 bottles; b) 2,384 bottles
Product Description
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).
Distribution Pattern
Nationwide within the United States
Code Information
a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027