niCARdipine Hydrochloride Injection — Class II drug recall D-0399-2025
Ongoing recall by American Regent, Inc., reported 2025-05-07, distributed nationwide. Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of
| Recall number | D-0399-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Regent, Inc., New Albany, OH, United States |
| Recall initiated | 2025-04-18 |
| Classified | 2025-05-01 |
| Reported by FDA | 2025-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 7,249 |
| Reason classes | sterility, packaging |
| NDC | 00517-0735, 00517-0735-01, 00517-0735-10 |
| Lot numbers | 24076N0C0, 24086N0C0, 24090N0C0, 25011N0C0 |
Product
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Reason for recall
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
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-0399-2025. 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.