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Class II · ModerateActive recall

Sterile Water

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: G171359, expiry: 05/31/2027
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byBaxter Healthcare Corporation
Brand nameSTERILE WATER
Generic nameWATER
Active ingredient(s)WATER
Distributed by / forBaxter Healthcare Corporation
NDC0338-0004-02
Show the full FDA record
Full product labelSterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Recalling firmBaxter Healthcare Corporation
DistributionNationwide
Quantity125,496 bottles
Recall initiated2025-12-22
Report date2026-02-04
Recall completed—
Recall numberD-0296-2026
ClassificationClass II
FDA statusOngoing
Origin on fileDeerfield IL United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.