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FDAClass II

niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Si… Recalled: Presence of Particulate Matter: Product contaminated with particulate matter identified a…

niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5… was recalled on July 24, 2026 in cooperation with the U.S. Food and Drug Administration because presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde.

Is my unit affected?

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.

Model, lot & date codes to check

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

Units affected: 43,460 vials

Where it was sold: Nationwide within the U.S

Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.

What's the hazard?

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

Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.

Your remedy & how to claim it

Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.

Contact: Recalling firm: American Regent, Inc.

Not sure what you're entitled to? Read our guide: what to do if your product is recalled.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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