FDA Recall D-0399-2025

American Regent, Inc. · New Albany, OH

Class II Ongoing 391 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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]

Lot / code: Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;

Quantity: 7,249 (cartons of 10 x 10 mL vials)

Reason for recall

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Recall record

Recall number: D-0399-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-04-18
Classified by FDA Center: 2025-05-01
FDA published: 2025-05-07
Recalling firm: American Regent, Inc.
Firm location: New Albany, OH

Drug identification

Brand name(s): NICARDIPINE HYDROCHLORIDE
Generic name(s): NICARDIPINE HYDROCHLORIDE
Manufacturer(s): American Regent, Inc.
NDC(s): 0517-0735
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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