Sterile Water for Irrigation recall (Baxter Healthcare Corporation)
DrugClass IIOngoing
Summary: Baxter Healthcare Corporation is recalling Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.. Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution.
What is being recalled
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Why
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
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
How to tell if yours is affected
Lot #: G171359, expiry: 05/31/2027
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-0296-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 22, 2025 |
| Reported | February 4, 2026 |
| Company | Baxter Healthcare Corporation |
| Company location | Deerfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 125,496 bottles |
More recalls from Baxter Healthcare Corporation · all drug recalls · recalls from December 2025