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FDADecember 22, 2025drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

baxter healthcarebaxter

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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