The FDA published on September 3, 2026 its announcement that 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 as iron oxide, inorganic, cellulose or polystyrene particulate matter.
0.9% Sodium Chloride Injection USP, 100 mL is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration and is packaged in non-PVC, non-DEHP flexible container system. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives.
Administration of 0.9% Sodium Chloride Injection USP, found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting). Systemically, foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells). To date there have been no reports of serious injury, death or other adverse events associated with this issue.
Product was distributed Nationwide to hospital and healthcare facilities from February 27, 2026 to August 3, 2026.
B. Braun is notifying its distributors and customers by mail and is arranging for return and replacement of all recalled products. Customers that have the recalled product should return to place of purchase.
On March 2, 2022, B. Braun Medical Inc. (B. Braun) announced that it was voluntarily recalling five (5) lots of 0.9% Sodium Chloride for Injection USP 250ML in Excel within the United States to the hospital/user level. The voluntary recall was initiated due to fluid leakage or low fill volume of the respective containers.
The biggest risk with a slow leak in any intravenous solution preparation is a break in sterility which poses a risk for the patient being exposed to a bacterial or fungal infection. There is a remote probability this could lead to bloodstream infection. B. Braun had not received any reports of adverse events related to the 2022 recall.
In November 2018, Fresenius Kabi USA voluntarily recalled 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert stated that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also stated that the stoppers do not contain latex. The product was recalled because the stoppers contain natural rubber latex.
For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction, and this could result in hospitalization or death. Fresenius Kabi USA had not received any reports of adverse events related to this recall.
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