Official recall notice

FDA DrugClass IINotable

Cyanocobalamin injection USP Recall (Aug 2026) – American Regent

Product: Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

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 #: 25082, Exp. Date: 3/31/2027.

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