Elevated risk U.S. Food and Drug Administration

Baxter Anticoagulant Sodium Citrate Solution USP 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: Foreign material — foreign objects

This is a foreign-material recall — foreign objects where there should be none. An affected pack looks identical to a sound one from the outside.

What the notice says: Administration of Anticoagulant Sodium Citrate containing particulate matter may lead to adverse health consequences, the extent and severity of harm depend on the size, number, morphology and composition of the foreign material.

Why it matters: Pieces of foreign objects may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: whether it shows up on imaging depends entirely on the material, so describe the product and the notice to them.

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

Published
August 25, 2026
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Baxter
Product type
Prescription & OTC drugs

Products covered by this recall

Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container

What the company announced

FOR IMMEDIATE RELEASE – AUG. 25, 2026 – DEERFIELD, Ill. , Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter identified as fiberglass in the solution.

Risk Statement : Anticoagulant Sodium Citrate Solution is intended for use with automated apheresis devices. Administration of Anticoagulant Sodium Citrate containing particulate matter may lead to adverse health consequences, the extent and severity of harm depend on the size, number, morphology and composition of the foreign material. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory or hypersensitivity reactions, and systemic embolization that could result in tissue or organ injury. As of 8/25/2026, Baxter has not received any reports of adverse events related to this issue.

The product is intended for use only with apheresis devices. It is not for direct intravenous infusion and the directions for use are contained in the owners operating and maintenance manual of the apheresis machine to be used. The product is packaged in 250 mL VIAFLEX Plastic Containers, with 36 units per case. Additional information can be found in the table below.

Affected Product :

  • Product Code: 2B7867Q · Product Description: Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container · Lot Number: Y493475 · Expiration Date: 31-Dec-2027 · NDC Number: 0338-9669-01

The affected lot 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 7/2/2026 to 7/11/2026 to one customer in the United States.

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

For general questions regarding this communication, please 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.

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 3 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.

  • Y493475

Best-by / use-by date

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

  • 31-Dec-2027

Package size

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

  • 250 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 Foreign material

Baxter — This is a foreign-material recall — foreign objects where there should be none. An affected pack looks identical to a sound one from the outside.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.
  3. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.
  4. If someone has already bitten into something hard, have them stop, spit out what is in their mouth and rinse rather than swallow.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

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 Administration of Anticoagulant Sodium Citrate containing particulate matter may lead to adverse health consequences, the extent and severity of harm depend on the size, number, morphology and composition of the foreign material.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code Y493475; best-by date 31-Dec-2027. 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 eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

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