FDA-Drug2026-09-02Class IICHEMICAL
Hikma Ramipril Capsules 10 mg recalled for failed impurity specifications
Nationwide distributionDrugs
What this means
Hikma Pharmaceuticals is recalling specific lots of Ramipril Capsules 10 mg because testing found higher-than-allowed levels of dicyclohexylurea, a process impurity. The affected lots are AC5470A and AC5470B, both expiring July 2027. No injuries have been reported.
- Check if your Ramipril prescription matches lot AC5470A or AC5470B with July 2027 expiration.
- Contact your pharmacy or doctor if you have one of these lots.
- Do not stop taking Ramipril without talking to your doctor first.
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
a) 25,970 bottles; b) 2,384 bottles
Manufactured in
1809 Wilson Rd, N/A, Columbus, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0831-2026Want us to check the next one for you?
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