FDA Drug recall D-0831-2026
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, Manuf…
- FDA Drug
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of 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, Manuf… by Hikma Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0831-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-24 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Pharmaceuticals Usa |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Identifiers
| ndc | 76282-670-01 |
|---|---|
| ndc | 76282-671-01 |
| ndc | 76282-671-05 |
| ndc | 76282-672-01 |
| ndc | 76282-672-05 |
| ndc | 76282-673-01 |
| ndc | 76282-673-05 |
| code_info | a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2023-05-24 · Hikma Pharmaceuticals Usa
All Hikma Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0831-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.