Reported Apr 29, 2026 · Ongoing
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA…
B Braun Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B BRAUN MEDICAL INC · 861 Marcon Blvd · Allentown, PA · 18109-9577
Is this the product you have?
- Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524
- NDC0264-7385-60
- Lot codes and dates
- Lot # J5H165
- Exp Date
31 May2028Lot # J5E237
- Exp Date30APR2028
- Amount recalled
- 24,928 bags
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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