Drug recall D-0793-2026
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.
Reason for recall
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Lots and codes
Lot #: 25082, Exp. Date: 3/31/2027.
Recall details
- Recalling firm
- American Regent, Inc., Shirley, NY
- Quantity
- 26,450 vials
- Distribution
- Nationwide within the U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 24, 2026
Related products
- Cyanocobalamin – drug information
- NDC 0517-0031 Cyanocobalamin · Cyanocobalamin 1000 ug/mL · American Regent, Inc.
- NDC 0517-0130 Cyanocobalamin · Cyanocobalamin 1000 ug/mL · American Regent, Inc.
- NDC 0517-0032 Cyanocobalamin · Cyanocobalamin 1000 ug/mL · American Regent, Inc.