FDA Drug recall D-0399-2025
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
- FDA Drug
- Class II
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class II recall of 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 by American Regent, citing lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0399-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-18 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Regent |
| Distribution | US |
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
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Identifiers
| ndc | 0517-0735-01 |
|---|---|
| ndc | 0517-0735-10 |
| code_info | Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026; |
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 I · 2026-08-26 · American Regent
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0399-2025%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.