Class II

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

Baxter Healthcare Corporation · December 22, 2025

Reason for Recall

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

Distribution

Nationwide

States Affected

NATIONWIDE

Quantity Affected

125,496 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0296-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.