FDA-Drug2026-08-26Class IIPROCESSING DEFECT
American Regent acetylcysteine solution recalled for particulate contamination
What this means
American Regent's acetylcysteine solution (10%, 100 mg/mL) in 4 mL vials has been found to contain particulate matter, including hair, glass, and/or paraformaldehyde. The contamination affects three specific lots distributed nationwide. This is a prescription medication for inhalation use only.
- Check your vials against lot numbers 24418 (exp. 11/30/2026), 25131 (exp. 3/31/2027), or 25349 (exp. 8/31/2027).
- Do not use affected vials.
- Contact your pharmacy or healthcare provider for replacement or alternative medication.
- Report any use of contaminated product to the FDA MedWatch program or your healthcare provider.
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
316,450 vials
Manufactured in
5 Ramsay Rd, Shirley, NY, United States
Products
ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0796-2026More 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
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