Recall Summary
| Recall number | D-0850-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-09-16 |
| Company | Baxter Healthcare Corporation |
| Units affected | 606 |
| 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-0850-2026 involves a concentrated IV solution used in hospitals and infusion pharmacies. The U.S. Food and Drug Administration posted the recall on September 16, 2026. It covers Dextrose Injection, USP, 70%, in 2000 mL bags. The FDA record says stainless steel particles were found in the solution. The agency rated it Class I, its most serious category. This guide explains what was recalled, why it matters, and what patients and families can do next.
What the Baxter Healthcare Recall Covers
The recalled product is Dextrose Injection, USP, 70%. It comes in 2000 mL bags. The label says “Rx Only,” so it is a prescription product. The label lists Baxter Healthcare Corporation in Deerfield, Illinois 60016. It also states “Made in USA.” The National Drug Code, or NDC, is 00338-0719-06.
According to the FDA record, the baxter healthcare recall covers 606 units. That is small compared to many drug recalls. However, the size of a recall does not show how serious it is. One contaminated bag can still pose a real risk. The official FDA notice is the place to confirm details such as lot numbers and expiration dates. Check that notice for the exact units involved.
Dextrose 70% is a highly concentrated sugar solution. In most cases, it is not given to patients straight from the bag. Instead, pharmacists typically use it as an ingredient in intravenous nutrition. This is often called parenteral nutrition, or TPN. As a result, the product is mostly handled by hospitals, infusion pharmacies, and home infusion providers. Most consumers would never buy it at a retail store.
The agency record we reviewed does not list where the bags were shipped. For example, it does not name specific hospitals, pharmacies, or states. If you or a family member receive IV nutrition, ask your care team. They can check whether any affected bags were used in your therapy.
The Hazard and Reported Injuries
The FDA record describes the problem as “presence of particulate matter.” The particles were identified as stainless steel. IV solutions are supposed to be free of foreign particles. That matters because the fluid flows directly into the bloodstream. The body has no digestive system in the way to filter it.
In general, particles in IV fluids can cause several kinds of harm. For example, they may block small blood vessels. They can also irritate or inflame the vein. In some cases, particles may cause tissue reactions or allergic responses. Critically ill patients, infants, and people on long-term IV nutrition may face higher risk. These are general medical risks. They are not findings specific to this recall.
The FDA classified this baxter healthcare recall as Class I. The FDA uses this category for serious situations. It means there is a reasonable probability the product could cause serious health problems or death. However, a Class I rating does not mean anyone was harmed. It describes the potential risk, not a confirmed outcome.
The agency record does not state whether any injuries have been reported. We will not guess either way. If the FDA or Baxter releases more information, it should appear in updated notices. The table below summarizes the key facts of the baxter healthcare recall from the agency record.
| Recall Number | D-0850-2026 |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Date | September 16, 2026 |
| Company | Baxter Healthcare Corporation |
| Product | Dextrose Injection, USP, 70%, 2000 mL bags, NDC 00338-0719-06 |
| Units Affected | 606 units |
| Severity | Class I |
| Injuries Reported | Not stated in the agency record |
What To Do If You Own This Product
Most people touched by this baxter healthcare recall will be patients, not product owners. Hospitals and pharmacies typically hold the inventory. Still, some patients receive IV nutrition at home. If that describes you, a few practical steps can help protect you.
First, do not stop any prescribed therapy on your own. Stopping IV nutrition suddenly can be dangerous. Instead, call your doctor or home infusion pharmacy right away. Ask whether your supplies include Dextrose Injection, USP, 70%, NDC 00338-0719-06. They can compare your lot numbers against the official notice.
Next, check any bags you have at home. Look for the product name, the 2000 mL size, and the NDC number. Do not use a bag that looks cloudy or has visible particles. Set any suspect bags aside. Do not throw them away until your provider tells you what to do. Keeping the bag may help with identification later.
The FDA record for this baxter healthcare recall contains remedy text that does not match the product. As a result, we are not stating a remedy here. Please follow the instructions in the official notice at the FDA Enforcement Report. You can also contact Baxter or ask your pharmacy. If you had a reaction, report it through FDA MedWatch.
Healthcare facilities should also review their stock. Pharmacy teams typically quarantine affected lots and document what was used. For example, they may check compounding records for any TPN made with this product. Those records can help doctors follow up with patients if needed.
Does a Baxter Healthcare Recall Mean You Can Sue?
A recall is not a lawsuit. It is a safety action. A recall warns the public that a product may be unsafe. It asks users and facilities to stop using the affected units. It does not decide who is at fault. It also does not decide whether anyone is owed money.
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This baxter healthcare recall does not, by itself, create a legal claim. We have not verified any lawsuit tied to this recall. In most cases, a product liability claim needs more than a recall notice. Typically, a person must show a real injury. They must also show the recalled product likely caused that injury.
For example, a patient who received an affected bag might later develop a documented complication. That patient may have questions worth exploring. Medical records, pharmacy records, and lot numbers can matter a great deal. As a result, it helps to keep copies of treatment records. Save any labels or packaging you still have.
If you believe you were harmed, consider speaking with a licensed attorney in your state. Many product liability lawyers offer free consultations. An attorney can review your facts and explain your options. You may be eligible to pursue a claim, but no outcome is guaranteed. Filing deadlines, called statutes of limitations, also apply.
How Recalls Connect to Mass Tort Cases
Recalls sometimes become evidence in later litigation. A recall notice can show when a company identified a problem. It can also show how many units were affected. Lawyers may also use inspection reports and internal documents. However, a recall alone does not prove that a product caused a specific injury.
The Philips CPAP recall is one well-known example. In 2021, Philips recalled millions of sleep apnea devices over foam that could break down. Lawsuits followed and were consolidated in federal court. Takata airbags are another example. Defective inflators led to one of the largest auto recalls in history. Years of litigation followed. In both cases, claims depended on evidence of harm, not the recall alone.
It is too early to say whether the baxter healthcare recall will lead to any litigation. Many recalls never do. Typically, lawsuits only follow when injuries are documented and linked to a product. We will update this page if verified legal developments occur.
Frequently Asked Questions
What product is included in the baxter healthcare recall?
The recall covers Dextrose Injection, USP, 70%, in 2000 mL bags with NDC 00338-0719-06. The FDA record lists 606 affected units. Check the official FDA notice for lot details.
Why is this baxter healthcare recall rated Class I?
Class I is the FDA’s most serious recall category. It applies when a product could reasonably cause serious health problems or death. Here, stainless steel particles were found in an IV solution.
Have any injuries been reported?
The agency record does not say whether injuries have been reported. We do not speculate either way. Watch the official FDA notice for any updates.
Am I entitled to compensation?
A recall alone does not mean you are entitled to compensation. If you were injured and can link it to the product, you may be eligible to pursue a claim. A licensed attorney can review your situation.
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.