Reported May 7, 2025 · Ongoing
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent,…
American Regent, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Regent, Inc. · 6610 New Albany Rd E · New Albany, OH · 43054-8730
Is this the product you have?
- 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 carton0517-0735-10 /
- NDC Vial0517-0735-01]
- Lot codes and dates
- Lots
- expiry
Lot 24086N0C07/31/2025Lot 24076N0C0Lot 24090N0C08/31/2025Lot 25011N0C06/30/2026
- Amount recalled
- 7,249 (cartons of 10 x 10 mL vials)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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