FDA MedWatch - Two Lots of 0.9% Sodium Chloride Injection by Baxter

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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.

As of 8/25/2026, Baxter has not received any reports of adverse events related to this issue.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The product being recalled is indicated as a source of water and electrolytes and is also indicated for use as a priming solution in hemodialysis procedures.

RECOMMENDATIONS: 

• 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.

• Consumers 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.

Health care professionals, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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