Drug & medication recalls Moderate risk

Baxter Healthcare Corporation recalls Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL…

Recall date
December 22, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0296-2026
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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.

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