SEE FULL FDA NOTICE

TOPIC: Two Lots of 0.9% Sodium Chloride Injection by Baxter: Recall – Due to Potential Presence of Particulate Matter

AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Pulmonology, Cardiology, Hematology

ISSUE: Baxter is recalling two lots of 0.9% Sodium Chloride Injection due to the potential presence of particulate matter identified as fiberglass in the solution.

Risk Statement: Intravenous administration of 0.9% Sodium Chloride Injection containing fiberglass particulate matter may lead to serious adverse health consequences. Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death. Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions.

The impacted product was distributed from 7/31/2026 to 8/3/2026 to healthcare providers and distributors to select states in the United States, including Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas, and Virginia.