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Class I: serious health riskOngoing

Baxter Healthcare 0.9% Sodium Chloride Injection 500 mL Recall

0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units pe…

Baxter Healthcare Corporation · Deerfield, IL

Risk level
Class I
Reported by FDA
Sep 9, 2026
Recall ID
D-0849-2026
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled 0.9% Sodium Chloride Injection 500 mL starting Aug 17, 2026. The FDA classified it as Class I (serious health risk) and published enforcement report D-0849-2026 on Sep 9, 2026. Reason: Presence of particulate matter: Particulates identified as fiberglass. Status: Ongoing.

Why it was recalled

Presence of particulate matter: Particulates identified as fiberglass

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Natonwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0849-2026
Classification
Class I
Status
Ongoing
Recall initiated
Aug 17, 2026
FDA report date
Sep 9, 2026
Quantity
145,464 500mL bags
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corporation

Original FDA data

Every field from FDA enforcement report D-0849-2026, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Ongoing
Country
United States
Event ID
99678
Address
1 Baxter Pkwy
Code information
Lot: Y495523, Y495523A, Exp 31-Oct-2027
Postal code
60015-4625
Report date
Sep 9, 2026
Product type
Drugs
Recall number
D-0849-2026
Classification
Class I
Recalling firm
Baxter Healthcare Corporation
Product quantity
145,464 500mL bags
Reason for recall
Presence of particulate matter: Particulates identified as fiberglass
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Natonwide in the USA
Recall initiation date
Aug 17, 2026
Initial firm notification
Letter
Center classification date
Sep 15, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0849-2026, published Sep 9, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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