FDA recall D-0802-2026

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 for recall

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Distribution

Nationwide within the U.S

Key facts

Status

Ongoing

Initiation date

2026-07-24

Report date

2026-08-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Shirley, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0802-2026