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 25-vial packages, because glass particles have been found in the medication. The affected product was distributed nationwide across all U.S. states and territories. This is a prescription-only injectable vitamin B12 product identified by NDC 0517-0031-25.
- 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
- Classification
- Class II
- 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/fb866840-275c-499c-b4d1-3c26871c346a