FDAClass IRecall started August 17, 2026

0.9% Sodium Chloride Injection USP 500 mL Recall: Particulate Matter

0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015…

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was 0.9% Sodium Chloride Injection USP 500 mL recalled?

Presence of particulate matter: Particulates identified as fiberglass

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

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

Which lot codes, UPCs or models are affected?

Lot: Y495523, Y495523A, Exp 31-Oct-2027

Agency record number
D-0849-2026
Product
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015…
Recalling firm
Baxter Healthcare Corporation
Quantity
145,464 500mL bags
Distribution
Natonwide in the USA
Recall started
August 17, 2026
Report date
September 9, 2026
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls