Sterile Water for Irrigation recall
FDA recall D-0296-2026 · initiated Dec 22, 2025
Baxter Healthcare Corporation recalled Sterile Water for Irrigation in Dec 2025 — an FDA Class II recall (D-0296-2026) because Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 125,496 bottles
Details
- Product
- Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
- Recalling company
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Dec 22, 2025
- FDA report date
- Feb 4, 2026
Frequently asked
- Was Sterile Water for Irrigation recalled?
- Baxter Healthcare Corporation recalled Sterile Water for Irrigation in Dec 2025 — an FDA Class II recall (D-0296-2026) because Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Sterile Water for Irrigation recalled?
- Per the FDA enforcement record, the reason for recall D-0296-2026 was: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
- Is a recalled Sterile Water for Irrigation dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sterile Water for Irrigation are affected?
- Distributed: Nationwide. The recall covers these lots — Lot #: G171359, expiry: 05/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0296-2026.