Official recall notice

FDA DrugClass IINotable

niCARdipine Hydrochloride Injection Recall (Aug 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.

Recall date
2026-08-26
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Affected products

Lot #: 25295N0C0, Exp. Date: 04/30/2027.

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