FDA-PR2026-08-27PROCESSING DEFECT

B. Braun 0.9% Sodium Chloride Injection recalled for zinc oxide particulate matter

Nationwide distributionDrugs

What this means

B. Braun Medical Inc. is recalling three lots of 0.9% Sodium Chloride Injection (saline solution) used in hospitals and healthcare settings. The recalled product contains particles of zinc oxide that should not be present. Intravenous fluids contaminated with particulate matter can cause serious complications including blood clots and organ damage. No injuries have been reported so far.

  • If you work in a hospital or healthcare facility, check your inventory for the affected lots (J6B435, J6B444, or J6B457, expiring April 30, 2027) and stop using them immediately.
  • Return recalled product to your supplier or contact B. Braun at recalls@bbraunusa.com or 8:00–5:00 p.m. EST, Monday–Friday.
  • If a patient received this product and develops breathing problems, chest pain, or other concerning symptoms, contact their physician right away.
  • Report any adverse effects to the FDA MedWatch program at www.fda.gov/medwatch/report.htm or 1-800-332-1088.

Product photos

Front panel of B. Braun 0.9% Sodium Chloride Injection USP, 100 mL, PAB® Container
Front panel of B. Braun 0.9% Sodium Chloride Injection USP, 100 mL, PAB® Container
The agency's original wording
Hazard

FOR IMMEDIATE RELEASE – August 19, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified a

Intended for
All ages (0 months and older)
Illnesses reported
None reported

Official notice

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-inc-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-100-ml-150

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