FDA drug recalls · openFDA

Is WATER recalled?

The FDA has recorded 3 recalls of WATER (2025–2026) , recalled under brand like STERILE WATER. 3 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of WATER ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. 1

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution 1

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 1801 Class II ongoing

B BRAUN MEDICAL INC 2026-04-02 lots: Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60. Class II ongoing

B BRAUN MEDICAL INC 2025-08-26 lots: Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 6 Class II ongoing

Baxter Healthcare Corporation 2025-12-22 lots: Lot #: G171359, expiry: 05/31/2027

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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