FDA Drug recall D-0793-2026
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 0517-0032-0…
- FDA Drug
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of 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 0517-0032-0… by American Regent, citing presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0793-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-24 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Regent |
| Distribution | US |
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
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Identifiers
| ndc | 0517-0031-01 |
|---|---|
| ndc | 0517-0031-25 |
| ndc | 0517-0032-01 |
| ndc | 0517-0032-25 |
| ndc | 0517-0130-01 |
| code_info | Lot #: 25082, Exp. Date: 3/31/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0793-2026%22
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