ACETYLCYSTEINE SOLUTION recall (American Regent, Inc.)
DrugClass IIOngoing
Summary: American Regent, Inc. is recalling 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.
What is being recalled
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.
Why
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the U.S
How to tell if yours is affected
Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0797-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 24, 2026 |
| Reported | August 26, 2026 |
| Company | American Regent, Inc. |
| Company location | Shirley, NY, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 169,200 vials |
More recalls from American Regent, Inc. · all drug recalls · recalls from July 2026