American Regent recalls 10% acetylcysteine solution vials due to contamination with hair, glass, and paraformaldehyde. Stop using if you have these vials.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent is recalling acetylcysteine solution vials that may contain hair, glass, or paraformaldehyde particles. This contamination could cause serious injury if the product is used.
The product contains hair, glass, or paraformaldehyde particles that could cause serious injury if the solution is used. These particles might enter the bloodstream or lungs during treatment.
People who have the recalled acetylcysteine solution vials (4 mL or 25x4 mL) for medical use. Those with respiratory conditions requiring this medication are most at risk.
Check for vials labeled 'ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL)' with NDC numbers 0517-7504-01 or 0517-7504-25. The product is prescription-only and sold by American Regent in Shirley, NY.
Immediately discard any recalled acetylcysteine solution vials that may contain particulate matter.
No, the product contains hair, glass, or paraformaldehyde particles that could cause serious injury. Do not use.
Discard the vials immediately and contact American Regent for further instructions.
Look for vials labeled 'ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL)' with NDC numbers 0517-7504-01 or 0517-7504-25.
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0796-2026 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0796-2026 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.
