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Drug FDA Class II Ongoing Contamination / non-sterility

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.

B BRAUN MEDICAL INC Published Apr 29, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact B BRAUN MEDICAL INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Lack of Sterility Assurance · primaryDiaphragm Port Leakage

Affected products (1)

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.

STERILE WATER · 24,928 bags

NDC: 0264-7385, 0264-7385-50, 0264-7385-60
Lot codes: J5H165, J5E237
Code info: Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 2, 2026
  2. Published
    Apr 29, 2026
Recall number
D-0495-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.