US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Dec 22, 2025 (8 months ago)

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution

What was recalled

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

Recalling firm
Baxter Healthcare Corporation
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0296-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.