FDA-Drug2026-08-26Class IIPROCESSING DEFECT
American Regent Cyanocobalamin injection recalled for particulate contamination
What this means
American Regent's Cyanocobalamin injection (vitamin B12) has been found to contain particulate matter, including hair, glass, and paraformaldehyde. The contamination affects specific lot numbers distributed nationwide. This is a prescription medication given by injection.
- If you have received this medication, contact your healthcare provider or pharmacy immediately with the lot number and expiration date from your vial.
- Do not use any vials from lot #24297 (expires 8/31/2026) or lot #24364 (expires 10/31/2026).
- Your healthcare provider can provide an alternative source of vitamin B12 if needed.
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
235,350 vials
Manufactured in
5 Ramsay Rd, Shirley, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0792-2026More 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 Tralement trace elements injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent aminocaproic acid injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent Selenious Acid Injection recalled for particulate contamination
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