August 2026 FDA Recall Sodium Chloride by Baxter Healthcare Corporation
D-0849-2026 - Presence of particulate matter
This Class I drug recall was voluntarily initiated by Baxter Healthcare Corporation on August 17, 2026 for the product Sodium Chloride. The FDA reported the reason for recall as presence of particulate matter. The product was distributed in Natonwide in the USA and the recall is currently ongoing.
Recall Number: D-0849-2026
Presence of particulate matter: Particulates identified as fiberglass
08-17-2026
09-09-2026
145,464 500mL bags
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Baxter Healthcare Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Natonwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot: Y495523, Y495523A, Exp 31-Oct-2027
