FDA-Drug2026-09-09Class IPROCESSING DEFECT
Baxter 0.9% Sodium Chloride Injection recalled for fiberglass contamination
What this means
Baxter Healthcare Corporation is recalling 0.9% Sodium Chloride Injection USP in 500 mL VIAFLEX plastic containers because some bags contain fiberglass particles. The affected lots are Y495523 and Y495523A, expiring October 31, 2027. No injuries have been reported.
- If you have received or are using bags from lot Y495523 or Y495523A, stop use immediately
- Contact your healthcare facility or pharmacy to report and return affected bags
- Consult your healthcare provider if you have already received an injection from an affected bag
The agency's original wording
Hazard
Presence of particulate matter: Particulates identified as fiberglass
Intended for
All ages (0 months and older)
Illnesses reported
None reported
Sold states
Natonwide in the USA
Affected count
145,464 500mL bags
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0849-2026More Baxter recalls
- FDA-Drug2026-09-16Baxter Dextrose Injection 70% recalled for stainless steel particles
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Drug2026-09-09Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations
- FDA-Drug2026-09-09Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
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