Recall Summary
| Recall number | D-0849-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-09-09 |
| Company | Baxter Healthcare Corporation |
| Units affected | 145,464 |
| Severity | Class I |
Remedy: Follow the instructions in the official notice linked below. The agency record for this recall did not contain remedy text we could verify against this product, so we have not reproduced it here.
Read the official U.S. Food and Drug Administration recall notice
Baxter Healthcare recall D-0849-2026 involves one of the most common IV fluids in American medicine. On September 9, 2026, the U.S. Food and Drug Administration posted a recall of Baxter’s 0.9% Sodium Chloride Injection USP in 500 mL VIAFLEX plastic containers. The reason is particulate matter identified as fiberglass. The FDA gave the recall a Class I rating, its most serious category. About 145,464 units are affected. If you or a family member receives IV fluids, this recall is worth understanding.
What the Baxter Healthcare Recall Covers
The recalled product is 0.9% Sodium Chloride Injection USP. It comes in 500 mL VIAFLEX plastic containers. Each case holds 24 units. The National Drug Code, or NDC, is 0338-0049-03. The label lists Baxter Healthcare Corporation of Deerfield, Illinois, and states the product was made in the USA.
This baxter healthcare recall covers 145,464 units in total. That is a large number for a single product listing. Normal saline like this is used every day in hospitals. It typically restores fluids, dilutes medications, and flushes IV lines. As a result, recalled units can reach many patients in a short time.
The agency data summarized here does not list specific lot numbers or expiration dates. It also does not describe exactly where the product was shipped. For those details, check the official FDA notice. Lot codes are the most reliable way to confirm whether a bag is affected. Do not rely on the product name alone.
In most cases, this product is handled by hospitals, clinics, surgery centers, and infusion providers. However, some patients receive IV therapy at home. Home health companies and specialty pharmacies may deliver saline bags directly to patients. If you keep IV supplies at home, check every 500 mL saline bag carefully.
The Hazard and Reported Injuries
The FDA record states the hazard plainly. The product may contain particulate matter. Those particulates were identified as fiberglass. Injectable fluids must be sterile and free of foreign particles. Any visible or hidden debris in an IV bag is a serious quality failure.
Particles in IV fluid enter the bloodstream directly. There is no filter like the stomach or skin to stop them. Past FDA recall notices describe several possible risks from particulates. For example, they can irritate or inflame veins. They may also block small blood vessels, including those in the lungs. Some patients may face higher risk, such as those with heart defects or weak immune systems.
The baxter healthcare recall was classified as Class I. This is the FDA’s most serious recall level. It means there is a reasonable probability that using the product could cause serious health problems or death. However, the classification describes potential risk. It is not a finding that harm actually occurred.
The agency record does not state whether any injuries have been reported. We cannot say either way. If you think you had a reaction after receiving saline, talk to your doctor. You can also report problems to FDA MedWatch. These reports help the agency track safety issues.
| Recall Number | D-0849-2026 |
|---|---|
| Issuing Agency | U.S. Food and Drug Administration |
| Date | September 9, 2026 |
| Company | Baxter Healthcare Corporation |
| Units Affected | 145,464 units |
| Severity | Class I |
What To Do If You Own This Product
First, confirm whether your product falls under the baxter healthcare recall. Look for 0.9% Sodium Chloride Injection USP in a 500 mL VIAFLEX container. Then find NDC 0338-0049-03 on the label. Finally, compare the lot number to the list in the official notice. If it matches, do not use it.
The agency record for this baxter healthcare recall contains remedy text that does not match the product. As a result, we have withheld it here. Please follow the instructions in the official notice instead. You can find it at the FDA Enforcement Report for drug recalls. That notice is the best source for return or replacement steps.
If you receive home infusion supplies, call your home health provider or pharmacy. They typically manage returns and replacement stock. Hospitals and clinics should follow their own recall procedures. In most cases, suppliers contact facilities directly. Still, patients can ask their care team whether recalled bags were used.
If you received IV fluid recently and feel unwell, contact your doctor. Watch for pain, redness, or swelling at the IV site. Seek emergency care right away for chest pain or trouble breathing. Keep any bag, label, or packaging you still have. Write down the date and place of your treatment.
Does a Baxter Healthcare Recall Mean You Can Sue?
A recall is not a lawsuit. It is a safety action by a company, often under FDA oversight. The goal is to remove a risky product from use. A baxter healthcare recall alone does not create a legal claim. It also does not mean anyone has been found at fault.
In most cases, a product liability claim needs more than a recall. You typically need an actual injury. You also need evidence that the product caused that injury. For example, medical records linking a reaction to a recalled lot could matter. Without injury and causation, a claim is usually not possible.
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We have not verified any lawsuit filed over this baxter healthcare recall. That could change as more information emerges. However, you should not assume a claim exists. You also should not assume a future claim would succeed. Every case depends on its own facts.
If you believe you were harmed, speak with a licensed attorney in your state. Many offer free first consultations. A lawyer can review your records and explain filing deadlines. Depending on the facts, you may be eligible to pursue a claim. However, no outcome is ever guaranteed.
How Recalls Connect to Mass Tort Cases
Recalls sometimes become evidence in later litigation. For example, Philips Respironics recalled millions of CPAP and BiPAP machines in June 2021. The problem was sound-reducing foam that could break down. Many users later filed lawsuits. Those cases were consolidated in federal court in Pennsylvania. The recall became a central part of that litigation.
Takata airbags offer another well-known example. Faulty inflators could rupture and spray metal fragments inside vehicles. The recalls became the largest in U.S. auto history. Injury lawsuits followed across the country. Takata eventually filed for bankruptcy. In both cases, the recall records helped document the defect.
However, not every recall leads to a mass tort. Many recalls end quietly with no litigation at all. Courts look at injuries, causation, and evidence. They do not treat a recall as automatic proof of liability. Whether this baxter healthcare recall leads to any litigation is unknown today.
For readers, the takeaway is simple. Keep records of any IV treatment and any symptoms afterward. Save lot numbers or packaging if you have them. These details help your doctor first. Later, they can help an attorney if you choose to seek advice.
Frequently Asked Questions
What product is part of the baxter healthcare recall?
The recall covers 0.9% Sodium Chloride Injection USP in 500 mL VIAFLEX plastic containers. The NDC is 0338-0049-03. Check the official FDA notice for lot numbers.
Have any injuries been reported?
The FDA agency record does not state whether injuries have been reported. We cannot confirm either way. If you had symptoms after IV treatment, contact your doctor.
How do I return or replace a recalled saline bag?
Follow the instructions in the official FDA notice linked on this page. Home infusion patients should also call their provider or pharmacy. They typically handle returns and replacements.
Is the baxter healthcare recall the same as a lawsuit?
No. A recall is a safety action, not a legal case. A claim typically requires an injury and proof the product caused it. A licensed attorney can explain whether you may be eligible.
Were You Injured by a Recalled Product?
A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.
Official Sources & Resources
Verify every recall against the issuing agency before acting:
- U.S. Food and Drug Administration: official recall database — the record of truth for this notice
- CPSC: cpsc.gov — household goods, toys, furniture, appliances
- FDA: fda.gov — food, drugs, and medical devices
- NHTSA: nhtsa.gov — vehicles, tires, and child car seats
- USDA FSIS: fsis.usda.gov — meat, poultry, and egg products
Content last reviewed September 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.
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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.