Class I U.S. Food and Drug Administration

Baxter 0.9% Sodium Chloride Injection, USP, 500 mL Viaflex Plastic Container recall: Potential presence of particulate matter identified as fiberglass

Recall published 2 months ago

Potential presence of particulate matter identified as fiberglass in the solution.

Baxter Prescription & OTC drugs — recalled prescription & otc drugsBaxter Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Sterility or particulate concern

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

What the notice says: Risk Statement: Intravenous administration of 0.9% Sodium Chloride Injection containing fiberglass particulate matter may lead to serious adverse health consequences.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0849-2026
Published
August 25, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Baxter
Product type
Prescription & OTC drugs
Units affected
145,464 500mL bags
Distribution
Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas, Virginia
Lot / code info
Lot: Y495523, Y495523A, Exp 31-Oct-2027

Products covered by this recall

0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container

What the company announced

FOR IMMEDIATE RELEASE – AUG. 25, 2026 – DEERFIELD, Ill. , Baxter International Inc. (NYSE:BAX) is voluntarily recalling two lots of 0.9% Sodium Chloride Injection due to the potential presence of particulate matter identified as fiberglass in the solution.

Risk Statement: Intravenous administration of 0.9% Sodium Chloride Injection containing fiberglass particulate matter may lead to serious adverse health consequences. Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death. Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions. As of 8/25/2026, Baxter has not received any reports of adverse events related to this issue.

The product is indicated as a source of water and electrolytes and is also indicated for use as a priming solution in hemodialysis procedures. The product is packaged in 500 mL VIAFLEX Plastic Containers, with 24 units per case. Additional information can be found in the table below.

Affected Product:

  • Product Code: 2B1323Q · Product Description: 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container · Lot Number: Y495523 · Expiration Date: 31-Oct-2027 · NDC Number: 0338-0049-03
  • Product Code: Y495523A

The affected lots can be identified by locating the lot number and expiration date on the individual product and shipping carton, as shown in the images below.

The impacted product was distributed from 7/31/2026 to 8/3/2026 to healthcare providers and distributors to select states in the United States, including Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas, and Virginia.

Customers should immediately discontinue use of and return all affected units in accordance with their facility’s process. Baxter is contacting customers by email with instructions on how to identify and return the impacted product.

Consumers with questions regarding this recall can contact Baxter Healthcare Center for Service at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

The United States Food and Drug Administration (FDA) has been notified of this action.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 0.9
  • Y495523
  • Y495523A

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 31-Oct-2027

NDC number

On the carton and again on the bottle or blister label.

  • 0338-0049-03

Model or item number

On the rating label, the box or the instruction sheet.

  • Y495523A

Package size

Match the net weight or the piece count on the front of the pack.

  • 500 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Baxter — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Baxter International Inc. — Consumers: Baxter Healthcare Center, 888-229-0001 — Media: Brenna Byrne, (224) 948-5353, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Baxter prescription & otc drugs recalled?

Potential presence of particulate matter identified as fiberglass in the solution. Risk Statement: Intravenous administration of 0.9% Sodium Chloride Injection containing fiberglass particulate matter may lead to serious adverse health consequences.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 0.9, Y495523, Y495523A; best-by date 31-Oct-2027; model number Y495523A. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Which states were affected?

The notice lists Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina and others.

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