FDA Drugs recall ·
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0849-2026
- Date
- (initiated August 17, 2026)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 145,464 500mL bags
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Presence of particulate matter: Particulates identified as fiberglass
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: Y495523, Y495523A, Exp 31-Oct-2027
Distribution
Natonwide in the USA
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0849-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.