Ramipril Capsules USP — Class II drug recall D-0831-2026
Ongoing recall by Hikma Pharmaceuticals USA INC., reported 2026-09-02, distributed nationwide. Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DC
| Recall number | D-0831-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA INC., Columbus, OH, United States |
| Recall initiated | 2026-08-24 |
| Classified | 2026-09-03 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 76282-0670, 76282-0670-01, 76282-0671, 76282-0671-01, 76282-0671-05, 76282-0672, 76282-0672-01, 76282-0672-05, 76282-0673, 76282-0673-01, 76282-0673-05 |
| Lot numbers | AC5470A, AC5470B |
| Expiration dates | 2027-07-20 |
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0831-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.