FDAFDA recall D-0831-2026 · Sep 2, 2026
Hikma Pharmaceuticals USA INC.: Ramipril Capsules USP recall
Recall found
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).
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
- Quantity
- a) 25,970 bottles; b) 2,384 bottles
- Distribution
- Nationwide within the United States
- Recalling firm
- Hikma Pharmaceuticals USA INC., Columbus, OH
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-24
Source: openFDA enforcement record D-0831-2026 · search recall number D-0831-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.