Recalling firm
Baxter Healthcare Corporation
Product type
Drug
Status
Ongoing
Report date
2026-02-04
Distribution
Nationwide
Firm state
IL
Product quantity
125,496 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Product description
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Code / lot info
Lot #: G171359, expiry: 05/31/2027
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.