Could cause temporary or reversible harm; serious harm is unlikely.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
| Brand name | CYANOCOBALAMIN |
| Generic name | CYANOCOBALAMIN |
| Active ingredient(s) | CYANOCOBALAMIN |
| Distributed by / for | American Regent, Inc. |
| NDC | 0517-0031-01 |
| Full product label | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. |
| Recalling firm | American Regent, Inc. |
| Distribution | Nationwide within the U.S |
| Quantity | 235,350 vials |
| Recall initiated | 2026-07-24 |
| Report date | 2026-08-26 |
| Recall completed | — |
| Recall number | D-0792-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Shirley NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗