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B. Braun Expands Sodium Chloride Injection Recall Over Particulate Matter

The FDA announced an expanded recall of B. Braun 0.9% Sodium Chloride Injection due to particulate matter, with no injuries reported.

3 reports on this incident · first at Aug 31, 2026, 9:15 p.m. ET

By AI ReporterFirst reported Aug 31, 2026, 8:30 p.m. ETWritten Aug 31, 2026, 9:52 p.m. ET
The U.S. Food and Drug Administration (FDA) has expanded a recall of 's , according to Medical Daily. The recall now includes lot numbers J6B435, J6B444, and J6B457, and NDC numbers S8004-5264 and 0264-1800-32, with an expiration date of April 30, 2027. The product was distributed . The recall was initiated because foreign particles were found in the fluid; the nature of the particles has changed since the recall was announced. Administering the injection could cause life-threatening consequences, including pulmonary emboli, occlusions of blood vessels, tissue death, organ damage, and phlebitis, according to the FDA notice. Facilities holding recalled product should return it to the place of purchase, per the FDA notice.

Earlier reports

  1. Aug 31, 2026, 9:23 p.m. ET

    B. Braun Sodium Chloride Injection Recall: No Injuries Reported, FDA Says

    The U.S. Food and Drug Administration (FDA) has announced a recall of certain lots of 0.9% Sodium Chloride Injection USP, 100 mL, supplied in a 150 mL PAB container, manufactured by B. Braun Medical Inc. The recall was initiated after foreign particles were found in the fluid, according to Medical Daily.

    The recall affects product distributed nationwide to hospitals and healthcare facilities from February 27 through August 3 of this year. The affected lots are identified by codes J6B435, J6B444, J6B457, S8004-5264, and 0264-1800-32, with an expiration date of April 30, 2027.

    The FDA notice states that administering the affected product has a reasonable probability of causing life-threatening consequences, including pulmonary emboli, occlusions of blood vessels that can lead to tissue death and organ damage, and phlebitis. However, B. Braun reports no injuries, deaths, or other adverse events associated with the issue.

    Facilities holding recalled product should return it to the place of purchase, according to the notice.

  2. Aug 31, 2026, 9:15 p.m. ETFirst report

    B. Braun Recalls Sodium Chloride Injection Over Particulate Matter

    B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection USP, 100 mL, supplied in a 150 mL PAB container, according to a notice reported by Medical Daily. The recall covers product distributed nationwide to hospitals and healthcare facilities from February 27 through August 3 of this year. The affected lots are identified by codes J6B435, J6B444, J6B457, S8004-5264, and 0264-1800-32, with an expiration date of April 30, 2027.

    The recall was initiated after foreign particles were found in the fluid. The FDA notice states that administering the injection with particulate matter has a reasonable probability of causing life-threatening consequences, including pulmonary emboli and occlusions of other blood vessels that can lead to tissue death and possible organ damage. The notice also cites phlebitis, inflammation of vein walls that may lead to clotting. B. Braun reports no injuries, deaths, or other adverse events associated with the issue.

    Facilities holding recalled product should return it to the place of purchase, according to the notice. The cause of the particulate matter has not been determined.

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Revision history

  1. Version 11 Sept 2026, 01:52current

    First published.

  2. Version 11 Sept 2026, 01:15current

    First published.

  3. Version 11 Sept 2026, 01:23current

    First published.

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