Water recalls: 5 FDA reports
Recalls involving Water. What was wrong with each batch, and how the FDA graded the risk.
5Reports
0Class I
3Ongoing
2026-04-29Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehe
D-0495-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Product
- Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
- Where it went
- US Nationwide.
- How much
- 24,928 bags
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerf
D-0296-2026 · Class II · reported 2026-02-04 · Ongoing
- Why it was recalled
- Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
- Product
- Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
- Where it went
- Nationwide
- How much
- 125,496 bottles
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60
D-0652-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
- Product
- STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
- Where it went
- U.S. Nationwide
- How much
- 26,316 3000 mL bags
Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06
D-1031-2022 · Class II · reported 2022-06-15 · Terminated
- Why it was recalled
- cGMP deviations: Temperature abuse
- Product
- Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06
- Where it went
- USA nationwide.
- How much
- unknown
Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Dis
D-0384-2021 · Class II · reported 2021-05-26 · Terminated
- Why it was recalled
- Presence of Particulate Matter: particulate matter identified as an insect in one vial.
- Product
- Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25
- Where it went
- Nationwide USA
- How much
- 49,525 vials
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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