Recall Ledger

0.9% Sodium Chloride Injection USP 500 mL recall (Baxter Healthcare Corporation)

DrugClass IOngoing

Summary: Baxter Healthcare Corporation is recalling 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. Reason: Presence of particulate matter: Particulates identified as fiberglass.

What is being recalled

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

Presence of particulate matter: Particulates identified as fiberglass

How serious is it

Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.

Where it was sold

Natonwide in the USA

How to tell if yours is affected

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

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0849-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass I
StatusOngoing
Recall startedAugust 17, 2026
ReportedSeptember 9, 2026
CompanyBaxter Healthcare Corporation
Company locationDeerfield, IL, United States
Initiated byVoluntary: Firm initiated
Quantity145,464 500mL bags

More recalls from Baxter Healthcare Corporation · all drug recalls · recalls from August 2026

Official FDA record