FDA recall, , Moderate risk
Baxter Sterile Water for Irrigation
Sterile Water for Irrigation contains plastic particles from the bottle rim that can float into the solution.
Summary by Recall Canary from the FDA notice
What happened
Baxter Healthcare Corporation of Deerfield, Illinois, recalled 125,496 bottles of Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, because plastic particles from the bottle rim were observed floating into the solution. The recall began December 22, 2025, and was added to the FDA's Enforcement Report on January 23, 2026, with distribution nationwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle
- NDC
- 0338-0004-02
- Lot code
- G171359
Recall details
- Company began the recall
- Sold in
- Nationwide
- Company
- Baxter Healthcare CorporationDeerfield, Illinois
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98178
- Recall number
- D-0296-2026
- Quantity recalled
- 125,496 bottles
All recalls from Baxter Healthcare Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
