FDA Drugs recall ·
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only… recall
- Recall number
- D-0296-2026
- Date
- (initiated December 22, 2025)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 125,496 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Why was it recalled?
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: G171359, expiry: 05/31/2027
Distribution
Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0296-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.