FDA recall, , High risk
Baxter 0.9% Sodium Chloride Injection
0.9% Sodium Chloride Injection contains fiberglass particulate matter that may cause serious health consequences.
Summary by Recall Canary from the FDA notice
What happened
Baxter Healthcare Corporation, based in Deerfield, Illinois, is voluntarily recalling 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case, due to the potential presence of particulate matter identified as fiberglass in the solution. The recall began on August 17, 2026, and was announced by the company on August 25, 2026, affecting 145,464 500mL bags distributed in the USA.
The product was added to the FDA's Enforcement Report on August 31, 2026, and included in the FDA's weekly enforcement report on September 9, 2026. The FDA classified the recall on September 15, 2026.
What to do
If a code on your package is listed below:
- Immediately discontinue use of and return all affected units in accordance with your facility’s process.
- 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.
- Contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this drug product.
Is yours affected?
Match the lot code, best-by or expiration date and NDC listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
2B1323Q
- NDC
- 0338-0049-03
- Lot code
- Y495523
- Y495523A
- Best-by or expiration date
- 31-Oct-2027
Recall details
- Company began the recall
- Sold in
Natonwide in the USA
- Company
- Baxter Healthcare CorporationDeerfield, Illinois
- Hazard
- Foreign object
- Risk
High risk
There is a reasonable chance that taking it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99678
- Recall number
- D-0849-2026
- Quantity recalled
- 145,464 500mL bags
All recalls from Baxter Healthcare Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Announced by the company
Listed on Recall Canary
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Summary updated
