Class IIDrug
Acetylcysteine Solution recall
Summary
American Regent, Inc. is recalling ACETYLCYSTEINE SOLUTION (drug). According to the FDA report, the reason is: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- Product
- 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.
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lot / code info
- Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.
- Quantity
- 169,200 vials
- Distribution
- Nationwide within the U.S
- Recalling company
- American Regent, Inc., Shirley, NY United States
- Recall started
- July 24, 2026
- FDA report date
- August 26, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0797-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (American Regent, Inc.) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.