American Regent recalls ACETYLCYSTEINE SOLUTION, USP 20% (200 mg/mL) vials due to contamination with hair, glass, and paraformaldehyde. Stop using immediately 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, and paraformaldehyde particles. This contamination could cause serious injury if the product is used as intended.
The product contains hair, glass, and paraformaldehyde particles that could cause injury if the solution enters the respiratory tract or is inhaled. Paraformaldehyde is a toxic chemical that can cause serious harm.
People who have the recalled ACETYLCYSTEINE SOLUTION vials (4 mL or 25x4 mL) for medical use. Those with respiratory conditions or who use the product for mucus thinning are at higher risk.
Check for vials labeled ACETYLCYSTEINE SOLUTION, USP 20% (200 mg/mL) with NDC 0517-7604-01 (4 mL) or NDC 0517-7604-25 (25x4 mL). These vials are for medical use only and not for injection.
Discard the recalled vials if you have them. Do not use the product.
No, the product contains harmful particles that could cause injury. Do not use the recalled vials.
Using the recalled vials could cause serious injury due to hair, glass, and paraformaldehyde particles entering the respiratory tract.
Check for vials labeled ACETYLCYSTEINE SOLUTION, USP 20% (200 mg/mL) with NDC 0517-7604-01 (4 mL) or NDC 0517-7604-25 (25x4 mL).
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0797-2026 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0797-2026 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.
