Recall - Baxter (0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container) produced by Baxter International Inc. - Potential presence of particulate matter[...]

Summary

Company Announcement

FOR IMMEDIATE RELEASE - AUG. 25, 2026 - DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily 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. As of 8/25/2026, Baxter has not received any reports of adverse events related to this issue.

The product is indicated as a source of water and electrolytes and is also indicated for use as a priming solution in hemodialysis procedures. The product is packaged in 500 mL VIAFLEX Plastic Containers, with 24 units per case. Additional information can be found in the table below.

Affected Product:

The affected lots can be identified by locating the lot number and expiration date on the individual product and shipping carton, as shown in the images below.

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.

Customers should immediately discontinue use of and return all affected units in accordance with their facility's process. Baxter is contacting customers by email with instructions on how to identify and return the impacted product.

Consumers with questions regarding this recall can contact Baxter Healthcare Center for Service at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

The United States Food and Drug Administration (FDA) has been notified of this action.