FDAFDA · Food and drugs·Recall number D-0797-2026
ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Published August 26, 2026 · Recall initiated: July 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- ACETYLCYSTEINE
- Manufacturer
- American Regent, Inc.
- Distributor
- Nationwide within the U.S
- UPC
- 0305177510032
- Lot
- Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.