FDA-PR2026-09-03PROCESSING 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 USP (a saline solution used in hospitals) because they contain tiny particles of zinc oxide. If injected intravenously, these particles could potentially cause blood clots, inflammation of veins, or in rare cases, blockages in blood vessels. No injuries have been reported so far.

  • If you work at a hospital or healthcare facility, check your inventory for the affected lot numbers: J6B435, J6B444, or J6B457.
  • Return recalled product to your supplier or place of purchase.
  • Contact your physician or healthcare provider if you or a patient received an injection from a recalled lot and have experienced any unusual symptoms.
  • Report any problems to the FDA MedWatch program at www.fda.gov/medwatch/report.htm or call 1-800-332-1088.
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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 – September 3, 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

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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