American Regent, Inc.: Cyanocobalamin Injection, Usp, 1000 Mcg/ml, 25 X

Recall Summary American Regent, Inc. is recalling Cyanocobalamin Injection (vitamin B12), 1000 mcg/mL in multi-dose vials, because glass particles have been found in the product. The affected vials were distributed nationwide across all U.S. states and Washington, D.C. This is a prescription medication, so the recall affects patients who received or have this injection on hand.

Recalling firm
American Regent, Inc.
Product
Cyanocobalamin Injection, USP, 1000 mcg/mL, 25 x 1 mL multi-dose vials, Rx only, American Regent INC, Shirley, NY, 11967, NDC 0517-0031-25, (Vial NDC: 0517-0031-01)
Reason
Presence of Particulate matter: Identified as glass
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-10-14
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide within the United States

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/d384013a-0229-43ea-8567-53fd0b002136