Baxter Recalls Two Lots of IV Saline Over Potential Fiberglass Particles, FDA Reports
Two lots of a widely used intravenous saline solution have been voluntarily recalled nationwide after Baxter International Inc. raised concerns that the products could contain particulate matter identified as fiberglass, according to the U.S. Food and Drug Administration.
The recall involves Baxter's 0.9% Sodium Chloride Injection, USP, a commonly used intravenous solution supplied in 500 mL VIAFLEX plastic containers. Baxter announced the voluntary recall on Aug. 25, 2026, and the FDA published the company's notice the following day.
The affected products were distributed to health care providers and distributors in several states between July 31 and Aug. 3. Although the company has not reported any adverse events connected to the issue as of Aug. 25, Baxter is advising customers to immediately stop using the affected lots and follow established procedures for returning them.
Which IV saline products are affected?
The recall applies specifically to two lots of Baxter 0.9% Sodium Chloride Injection, USP, packaged in 500 mL VIAFLEX plastic containers.
The affected lot numbers are:
- Y495523
- Y495523A
Both lots have a labeled expiration date of Oct. 31, 2027. The product code is 2B1323Q, and the National Drug Code listed by the FDA is 0338-0049-03. The lot number and expiration date can be found on the individual product and its shipping carton.
The FDA says the affected products were distributed from July 31 through Aug. 3 to health care providers and distributors in Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas, and Virginia.
The recall is described as nationwide, but the FDA's notice identifies these states as the locations where the affected product was distributed.
Why was the saline recalled?
The concern centers on the possible presence of particulate matter identified as fiberglass in the solution.
Intravenous products are administered directly into the bloodstream, which means unwanted particles can present a serious safety concern. Baxter's recall notice warns that particulate matter in an IV solution could potentially cause blood vessel blockage or clotting.
According to the company, such complications could interfere with blood flow to vital organs. In serious circumstances, a blood clot could travel to the lungs and cause a pulmonary embolism. Baxter also warns of the possibility of permanent organ damage or death.
Other potential reactions listed in the recall notice include irritation of the vein, inflammatory reactions, worsening of existing infections, and allergic reactions.
These warnings describe potential risks associated with intravenous administration of particulate matter. They do not mean that every person exposed to an affected product will experience these complications.
As of Aug. 25, Baxter said it had not received reports of adverse events related to this particular issue.
What is normal saline used for?
0.9% sodium chloride injection, commonly called normal saline, is one of the most frequently used intravenous fluids in medical settings.
The solution provides water and electrolytes and can be used in a variety of clinical situations. Baxter's FDA-listed product information also identifies it for use as a priming solution during hemodialysis procedures.
Depending on the medical situation, saline solutions can also be used as part of medication administration or fluid replacement. Because these products are administered intravenously, manufacturing quality and the absence of unwanted particulate matter are important safety considerations.
What should hospitals and health care providers do?
Baxter is instructing customers to immediately discontinue use of the recalled products.
Facilities that have the affected lots should identify the products using the lot numbers and expiration date and return them according to their established facility procedures. Baxter said it is contacting customers by email with instructions for identifying and returning the affected products.
Health care facilities should not assume that every Baxter saline product is affected. The recall applies to the specifically identified lots, so checking the lot number is important.
Patients who are concerned about receiving the recalled product should speak with their physician or other health care professional rather than stopping or changing medical treatment on their own.
Baxter has provided a customer service number for questions about the recall. The Baxter Healthcare Center for Service can be reached at 888-229-0001, Monday through Friday from 7 a.m. to 6 p.m. Central Time.
How can adverse events be reported?
The FDA says adverse reactions or quality problems associated with the product can be reported through its MedWatch Adverse Event Reporting program.
MedWatch allows health professionals and consumers to report suspected problems involving FDA-regulated medical products. The FDA's recall notice provides instructions for submitting reports online, by mail, or by fax.
Consumers who believe they experienced a medical problem after receiving a recalled product should contact their health care provider. Medical professionals can also help determine whether symptoms may be associated with a particular treatment or product.
Other Baxter recalls announced this week
The saline recall is not the only Baxter product recall announced around the same time.
On Aug. 25, Baxter also announced a voluntary recall involving one lot of Anticoagulant Sodium Citrate Solution USP because of the potential presence of particulate matter identified as fiberglass.
The company also recalled one lot of 70% Dextrose Injection, USP, after concerns about the possible presence of stainless steel particles. The affected dextrose product was a 2,000 mL VIAFLEX container, and the FDA identified lot Y495066 with an expiration date of July 31, 2027.
The FDA's drug recall listings show the Baxter saline, sodium citrate, and dextrose actions among the recent drug recalls reported by the agency.
These recalls involve different products and different potential particulate materials, so consumers and health care facilities should review the specific FDA notices rather than assuming that one recall applies to all Baxter products.
What consumers should know
The latest recall does not mean that all 0.9% sodium chloride injection products have been recalled.
The FDA notice specifically identifies two Baxter lots of the 500 mL VIAFLEX product. Anyone handling or administering the product should check the lot number and expiration date against the official recall information.
Patients who are currently receiving intravenous treatment should not make changes to their treatment based solely on news reports. Health care professionals and medical facilities are responsible for determining whether a specific product or lot is affected and for selecting an appropriate alternative when necessary.
The FDA's official recall notice remains the best source for identifying the affected products and reviewing the company's instructions.
Bottom line
Baxter International has voluntarily recalled two lots of 0.9% Sodium Chloride Injection, USP, after identifying a potential risk involving particulate matter described as fiberglass.
The affected lots are Y495523 and Y495523A, packaged in 500 mL VIAFLEX plastic containers and labeled with an expiration date of Oct. 31, 2027. The products were distributed to health care providers and distributors in multiple U.S. states between July 31 and Aug. 3.
Baxter is instructing customers to stop using the affected products immediately and return them according to their facility's procedures. While the company reported no adverse events associated with the issue as of Aug. 25, it warns that intravenous administration of particulate matter could result in serious complications.
For the most accurate and current information, health care facilities and consumers should consult the FDA's official recall notice and Baxter's recall instructions rather than relying on social media posts or secondary reports.
Sources
- U.S. Food and Drug Administration, "Baxter Issues Voluntary Nationwide Recall for Two Lots of 0.9% Sodium Chloride Injection Due to Potential Presence of Particulate Matter.
- U.S. Food and Drug Administration, Baxter sodium citrate recall notice.
- U.S. Food and Drug Administration, Baxter 70% dextrose recall notice.
Disclaimer
This article is provided for informational purposes only and is based on publicly available information from the U.S. Food and Drug Administration and Baxter International. It is not medical advice and should not be used as a substitute for guidance from a qualified health care professional. Product recall information can change, so readers should consult the FDA and the manufacturer for the latest official information. Patients should speak with their physician or health care provider about any concerns regarding treatment or possible exposure to a recalled product.