Two Lots of Baxter Sodium Chloride Injection Recalled Over Fiberglass Risk
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Fiberglass particles floating inside an intravenous fluid bag can trigger blood clots, cut off circulation to vital organs, and in severe cases prove fatal. That is the danger behind a voluntary nationwide recall announced by Baxter International Inc. on August 25, 2026, covering two lots of its 0.9% Sodium Chloride Injection used daily in hospitals and dialysis centers across the country.
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The Deerfield, Illinois-based healthcare company said routine oversight identified the possible presence of particulate matter identified as fiberglass within the solution. Because the product is administered directly into a patient’s bloodstream, even microscopic contaminants pose a heightened safety concern compared with products taken orally.
Products Affected by This Recall
The recall applies specifically to 0.9% Sodium Chloride Injection, USP, packaged in 500 mL VIAFLEX Plastic Containers, with 24 units included per case. The affected product carries product code 2B1323Q and NDC number 0338-0049-03.
- Lot Number: Y495523
- Lot Number: Y495523A
- Expiration Date: October 31, 2027
- Container: 500 mL VIAFLEX Plastic Container
Facilities can confirm whether they hold recalled stock by checking the lot number and expiration date printed on both the individual product bag and the outer shipping carton.
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What Went Wrong?
According to Baxter’s announcement, the issue centers on particulate matter identified as fiberglass detected in the sodium chloride solution. Intravenous administration of fluid containing such particles ‘may lead to serious adverse health consequences,’ the company stated. Particulate matter introduced into the bloodstream can cause blockage and clotting in blood vessels, cutting off blood flow to vital organs. In more severe scenarios, this can progress to a life-threatening pulmonary embolism or cause permanent organ damage or death. The particles may also trigger local vein irritation, inflammatory reactions, aggravation of existing infections, and allergic responses.
Baxter noted that, as of August 25, 2026, it had not received any reports of adverse events connected to the affected lots. The product itself is intended as a source of water and electrolytes and is also used as a priming solution during hemodialysis procedures.
Where Were These Products Sold?
The impacted lots were distributed between July 31 and August 3, 2026, to healthcare providers and distributors in select states, including Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas, and Virginia. Because the product moves through hospital and clinical supply chains rather than retail shelves, individual consumers would not have purchased it directly.
Steps Consumers Should Take
Healthcare facilities that received the affected lots are being instructed to immediately discontinue use and return all impacted units according to their facility’s established return process. Baxter said it is contacting customers directly by email with specific instructions for identifying and returning the product.
Patients who believe they may have received an infusion from an affected lot, or who experience unusual symptoms following treatment, should contact their physician or healthcare provider promptly. Anyone with questions about the recall can reach Baxter Healthcare Center for Service at 888-229-0001, available 7:00 a.m. to 6:00 p.m. Central Time, Monday through Friday.
Adverse reactions or quality issues tied to this product can also be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail, or by fax, using the standard MedWatch reporting form.
From the Agency
The FDA confirmed it has been notified of Baxter’s voluntary action and posted the company’s announcement as a public service, noting that the agency does not endorse either the product or the company involved. The recall remains a company-initiated, voluntary action rather than an FDA-mandated order.
Baxter’s media contact for the recall is Brenna Byrne, reachable at (224) 948-5353. The company emphasized that patient safety remains its priority as it works with affected healthcare facilities to remove the two lots from circulation.
Official Source: View original notice on FDA →
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