Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
niCARdipine Hydrochloride Injection Recalled by American Regent, Inc. Due to Lack of sterility assurance: Product leakage around the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact American Regent, Inc. directly.
Affected Products
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]
Quantity: 7,249 (cartons of 10 x 10 mL vials)
Why Was This Recalled?
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About American Regent, Inc.
American Regent, Inc. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report