American Regent, Inc. recalls niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-0
Recalled August 26, 2026 · FDA recall D-0802-2026 · American Regent
Hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde · FDA Class II
Units
43,460 vials
Sold at
Nationwide within the U.S
Description
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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.
Manufacturer(s)
American Regent, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →