American Regent recalls certain niCARdipine Hydrochloride Injection vials due to potential contamination from leakage around the vial neck. This could lead to lack of sterility assurance in medical use.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
American Regent has recalled specific niCARdipine Hydrochloride Injection vials because leakage around the neck may cause contamination. This poses a risk to patients receiving the medication.
Leakage around the vial neck could allow contaminants to enter the injection, potentially causing infection or other complications. This is a sterility issue that affects medical use.
Patients prescribed this medication by a healthcare provider. Those using the product for medical treatment are most at risk.
Check for vials labeled 'niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only'. The product was manufactured for specific lots with expiry dates listed in the recall notice.
Identify the vial by its label and lot numbers: 24025N0C0 (expiring 6/30/2025), 24115N0C0 (10/31/2025), 24116N0C0 (3/31/2026), 24160N0C0 (12/31/2025), 24217N0C0 (01/31/2026), 24288N0C0 (04/30/2026), 24331N0C0 (5/31/2026).
The product has been recalled due to potential contamination from leakage around the vial neck. It is not safe for medical use without the recall remedy.
Look for vials with the specific lot numbers listed in the recall notice: 24025N0C0 through 24331N0C0.
The recall does not specify a remedy, so contact your healthcare provider for guidance on safe handling or disposal.
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0398-2025 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0398-2025 from American Regent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
