Class IIOngoing

niCARdipine Hydrochloride Injection recall

FDA recall D-0399-2025 · initiated Apr 18, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

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]
Recalling company: American Regent, Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Apr 18, 2025
FDA report date: May 7, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0399-2025 ↗

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