CLASS II ONGOING Drug recall · Reported 4 Feb 2026 · FDA Enforcement Report

Sterile Water for Irrigation, Single-Dose recalled by Baxter Healthcare

Baxter Healthcare is recalling Sterile Water for Irrigation, Single-Dose, distributed nationwide in the US. The recall was initiated on 22 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: G171359, expiry: 05/31/2027

NDC0338-0003, 0338-0004

Quantity recalled125,496 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0296-2026
FDA event ID: 98178
Recalling firm: Baxter Healthcare, Deerfield, IL
Brand: Sterile Water
Manufacturer: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Recall initiated: 22 Dec 2025
FDA classified: 23 Jan 2026
Reported: 4 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter

Timeline

22 Dec 2025	Recall initiated by company
23 Jan 2026	Classified by FDA	+32 days
4 Feb 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot #: G171359, expiry: 05/31/2027

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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All 572

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16 Sep 2026Drug	CLASS I	Dextrose Injection, USP, 70 % recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide
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Other Water recalls

All 13

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026Drug	CLASS II	Sterile Water for Injection recalled by B Braun MedicalSterile Water	B Braun Medical	Sterility	Nationwide
24 Sep 2025Drug	CLASS II	Sterile Water For Injection recalled by B Braun MedicalSterile Water	B Braun Medical	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Sterile Water for Injection, USP, mL Single-Dose Vials recalledSterile Water	Nephron Sc	Manufacturing (CGMP) Deviations	SC
1 Feb 2023Drug	CLASS II	Sterile Water for Injection recalled by Nephron ScSterile Water	Nephron Sc	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Sterile Water for Injection recalled by Mckesson Medical-SurgicalSterile Water	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide