American Regent, Inc. recalls ACETYLCYSTEINE SOLUTION
- Recalling company
- American Regent, Inc.
- Product
- 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.
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 24, 2026
- Reported
- Aug 26, 2026
- Distribution
- Nationwide within the U.S
- Status
- Ongoing
- Quantity
- 316,450 vials
- Lot / codes
- Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027
- Company location
- Shirley, NY
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0796-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0796-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.