Recall: D-0296-2026

Class II - Potentially Harmful

Class IIClassification
2025-12-22Initiated
OngoingStatus
Baxter Healthcare CorporationFirm

Product

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

Reason

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.