American Regent recalls cyanocobalamin injections with particulate matter (hair, glass, paraformaldehyde) that could cause serious injury if injected. Stop using and contact for replacement.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent is recalling cyanocobalamin injections that contain particulate matter like hair, glass, or paraformaldehyde. This could cause serious injury if injected, so affected users should stop using the product immediately.
The injections contain small particles of hair, glass, or paraformaldehyde. If injected, these particles could cause serious injury such as tissue damage or infection.
Healthcare professionals who use these injections for medical treatment. Patients receiving injections from this product are at risk of serious injury.
Look for the product labeled 'Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only' in 10 mL Multi-Dose Vials (NDC 0517-0032-01) or 25x10 mL Multi-Dose Vials (NDC 0517-0032-25).
Immediately stop using the recalled cyanocobalamin injections as they contain harmful particles that could cause serious injury.
The injections contain particulate matter including hair, glass, and paraformaldehyde, which could cause serious injury if injected.
Check for the product labeled 'Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only' in 10 mL Multi-Dose Vials (NDC 0517-0032-01) or 25x10 mL Multi-Dose Vials (NDC 0517-0032-25).
Stop using the product immediately and contact American Regent for a replacement.
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0793-2026 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0793-2026 from American Regent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
