American Regent, Inc. recalls niCARdipine Hydrochloride Injection
- Recalling company
- American Regent, Inc.
- Product
- niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 24, 2026
- Reported
- Aug 26, 2026
- Distribution
- Nationwide within the U.S
- Status
- Ongoing
- Quantity
- 43,460 vials
- Lot / codes
- Lot #: 25295N0C0, Exp. Date: 04/30/2027.
- Company location
- Shirley, NY
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0802-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0802-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.