Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxte...

Published: February 4, 2026Recall ID: D-0296-2026Category: drugsCountry: US

Reason for Recall / Hazard

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

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

Field	Value
City	Deerfield
State	IL
Openfda › Unii	059QF0KO0R
Openfda › Route	IRRIGATION
Openfda › Rxcui	150985
Openfda › Spl id	97390588-b679-4caa-b7f3-3d2e11074d0e
Openfda › Brand name	STERILE WATER
Openfda › Spl set id	ef3e79c5-3f58-4b36-a296-64b7d9a651c1
Openfda › Package ndc › 1	0338-0003-44
Openfda › Package ndc › 2	0338-0003-46
Openfda › Package ndc › 3	0338-0003-47
Openfda › Package ndc › 4	0338-0004-02
Openfda › Package ndc › 5	0338-0004-03
Openfda › Package ndc › 6	0338-0004-04
Openfda › Package ndc › 7	0338-0004-05
Openfda › Product ndc › 1	0338-0003
Openfda › Product ndc › 2	0338-0004
Openfda › Generic name	WATER
Openfda › Product type	HUMAN PRESCRIPTION DRUG
Openfda › Substance name	WATER
Openfda › Manufacturer name	Baxter Healthcare Corporation
Openfda › Application number	NDA017866
Openfda › Is original packager	true
Event id	98178
Address 1	1 Baxter Pkwy
Address 2	N/A
Code info	Lot #: G171359, expiry: 05/31/2027
Postal code	60015-4625
Report date	20260204
Product type	Drugs
Product quantity	125,496 bottles
Reason for recall	Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Voluntary mandated	Voluntary: Firm initiated
Recall initiation date	20251222
Initial firm notification	Letter
Center classification date	20260123