Why it was recalled
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Product description
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Lot numbers, UPCs & expiration codes
Lot #: G171359, expiry: 05/31/2027
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0296-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 22, 2025
- FDA report date
- Feb 4, 2026
- Quantity
- 125,496 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0296-2026, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 98178
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: G171359, expiry: 05/31/2027
- Postal code
- 60015-4625
- Report date
- Feb 4, 2026
- Product type
- Drugs
- Recall number
- D-0296-2026
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 125,496 bottles
- Reason for recall
- Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 22, 2025
- Initial firm notification
- Letter
- Center classification date
- Jan 23, 2026