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FDAFDA · Food and drugs·Recall number D-0793-2026

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.

Published August 26, 2026 · Recall initiated: July 24, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Press Release

Recall details

Brand
CYANOCOBALAMIN
Manufacturer
American Regent, Inc.
Distributor
Nationwide within the U.S
UPC
0305170031251
Lot
Lot #: 25082, Exp. Date: 3/31/2027.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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