FDA-Drug2026-08-26Class IIPROCESSING DEFECT
American Regent cyanocobalamin injection recalled for particulate contamination
What this means
American Regent's cyanocobalamin (vitamin B12) injection has been recalled due to contamination with particulate matter, including hair, glass, and/or paraformaldehyde. The affected product is a 10,000 mcg/10 mL multi-dose vial (Lot #25082, expiring 3/31/2027). This is a prescription medication administered by injection.
- If you have received this medication, do not use it.
- Contact your healthcare provider or pharmacist immediately with the lot number and expiration date.
- Return the vial to your pharmacy or healthcare facility.
The agency's original wording
Hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
26,450 vials
Manufactured in
5 Ramsay Rd, Shirley, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0793-2026More American Regent recalls
- FDA-Drug2026-09-16American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-PR2026-09-03American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-Drug2026-08-26American Regent Cyanocobalamin injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent Tralement trace elements injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent aminocaproic acid injection recalled for particulate contamination
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.