Class II

Drug Recall: 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]

American Regent, Inc. · April 18, 2025

Reason for Recall

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

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

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

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0399-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.