Latest recalls
FDAClass IIAugust 26, 2026

Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only

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.

Why it was recalled

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

What to do

The recall is ongoing. Follow the firm and FDA instructions.

Affected products and identifiers

Lot #: 25082, Exp. Date: 3/31/2027. — 26,450 vials

Record details

American Regent, Inc. — Nationwide within the U.S

Open FDA enforcement record