Baxter 70% Dextrose Injection, USP in 2000 mL Viaflex Plastic Container recall: Potential presence of particulate matter identified as stainless steel

What the company announced

FOR IMMEDIATE RELEASE – AUG. 25, 2026 – DEERFIELD, Ill. , Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of 70% Dextrose Injection due to the potential presence of particulate matter identified as stainless steel particles in the solution.

Risk Statement : Intravenous administration of 70% Dextrose Injection containing stainless steel 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.

This product is used as a source of calories and fluid replenishment when mixed with amino acids or other compatible intravenous fluids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated. The product is packaged in 2000 mL VIAFLEX Plastic Container, with 6 units per case. Additional information can be found in the table below.

Affected Product:

• Product Code: 2B0296H · Product Description: 70% Dextrose Injection, USP in 2000 mL VIAFLEX Plastic Container. Pharmacy Bulk Package, Not for Direct Infusion · Lot Number: Y495066 · Expiration Date: 31-Jul-2027 · NDC Number: 0338-0719-06

The affected lot 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 7/25/2026 to 7/28/2026 to healthcare providers and distributors to select states in the United States, including Alabama, Georgia, and Tennessee.

Customers should immediately discontinue use of and return all affected units in accordance with their facility’s process. Homecare facilities who used this lot to compound parenteral nutrition solutions should contact their patients to alert them to discontinue using the solutions and replace them with ones not compounded with the affected lot. 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.htm 2 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.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.