Recall Summary
| Recall number | D-0773-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-08-19 |
| Company | Liebel-Flarsheim Company LLC |
| Units affected | 3,486 |
| 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
The liebel-flarsheim optiray recall is a Class I action from the U.S. Food and Drug Administration. It covers Optiray Imaging Bulk Package-350, a contrast agent used during medical imaging. The FDA assigned it recall number D-0773-2026 on August 19, 2026. Regulators found particulate matter inside the product. Class I is the agency’s most serious category. It means there is a reasonable probability that use of the product could cause serious health problems or death. If you received contrast dye during a scan, this notice may matter to you.
What the Liebel-Flarsheim Optiray Recall Covers
The recalled product is Optiray Imaging Bulk Package-350, Ioversol Injection 74%. Its strength is 350 mg/mL organically bound iodine. It ships in a 500 mL multiple-dose vial. The label lists it as Rx only and as a sterile solution. The NDC code is 0019-1333-65. Liebel-Flarsheim Company LLC manufactured it in Raleigh, North Carolina. The label states Made in USA.
The liebel-flarsheim optiray recall covers 3,486 units. That figure comes directly from the FDA record. It is a large quantity for a hospital-grade injectable. Bulk packages like this one are drawn into injector systems. A single vial may serve more than one imaging procedure. As a result, the reach of the recall can extend beyond the vial count itself.
Optiray is not a consumer product. You cannot buy it at a pharmacy counter. It is distributed to hospitals, imaging centers, and radiology departments. Typically, a technologist or radiologist administers it. Patients rarely see the vial or its label. For example, a person receiving a CT scan may never learn the brand name of the contrast used.
The FDA record does not publish a full lot list on this page. Facilities should check the official notice for identifying codes. In most cases, the manufacturer distributes a direct letter to affected customers. That letter carries the specific lot numbers and expiration dates. The liebel-flarsheim optiray recall notice is the controlling document for those details.
The Hazard and Reported Injuries
The hazard in the liebel-flarsheim optiray recall is particulate matter. The FDA describes it as polyethylene and other plastic materials, stainless steel, and glass. These are foreign particles that do not belong in an injectable solution. Contrast media go directly into a patient’s bloodstream. Anything suspended in the fluid travels with it.
Injected particulate matter is a recognized safety concern in sterile drug manufacturing. Particles can, in general terms, trigger local reactions at the injection site. They may also travel through the vascular system. Regulators treat visible and subvisible particles in injectables seriously for that reason. However, the specific outcomes in this recall are not detailed in the agency record.
The FDA record does not state whether any injuries have been reported. This guide will not claim that injuries occurred. It will also not claim that none occurred. Neither statement is supported by the agency data. What the record does establish is severity. The liebel-flarsheim optiray recall carries a Class I classification.
| Recall number | D-0773-2026 |
|---|---|
| Issuing agency | U.S. Food and Drug Administration |
| Recall date | August 19, 2026 |
| Company | Liebel-Flarsheim Company LLC |
| Units affected | 3,486 |
| Severity classification | Class I |
Class I is the FDA’s highest recall tier. It is reserved for situations with a reasonable probability of serious harm or death. Class II covers temporary or reversible problems. Class III covers issues unlikely to cause harm. The liebel-flarsheim optiray recall sits at the top of that scale.
What To Do If You Own This Product
If your facility stocks this product, stop using it now. Quarantine the affected vials immediately. Separate them physically from usable inventory. Label the quarantine area clearly so staff do not pull from it. Typically, pharmacy and radiology leadership coordinate this step together.
Identify the product by its label details. Look for Optiray Imaging Bulk Package-350 and Ioversol Injection 74%. Confirm the 350 mg/mL strength and the 500 mL multiple-dose vial size. Match the NDC code 0019-1333-65. Then check lot numbers against the official notice.
Do not guess at the return or replacement process. The remedy instructions for the liebel-flarsheim optiray recall are not restated here. The agency record contains remedy language that does not match this product. As a result, we have withheld it rather than risk misdirecting you. Follow the instructions in the official notice linked on this page.
Patients have a different set of steps. You will not have the vial. Instead, contact the facility that performed your imaging. Ask whether they used product from the affected lots. If you have symptoms after a contrast scan, contact your doctor. Report any suspected adverse event to the FDA MedWatch program.
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Does a Liebel-Flarsheim Optiray Recall Mean You Can Sue?
A recall is not a lawsuit. That distinction matters. A recall is a regulatory safety action. It removes a product from use to prevent harm. It is a forward-looking correction, not a finding of legal liability. The liebel-flarsheim optiray recall does not, by itself, establish that anyone was hurt.
A legal claim generally requires more than a recall notice. In most cases, a person must show an actual injury. They must also show that the defective product caused that injury. Lawyers call this causation. Medical records, imaging dates, and lot documentation often matter here. Without those links, a recall alone is not a claim.
If you received contrast during the relevant period and became ill, you may be eligible to pursue a claim. That is a possibility, not a promise. No outcome is guaranteed. Nothing on this page is legal or medical advice. A licensed attorney in your state should evaluate your specific facts.
Deadlines also apply. Every state sets a statute of limitations for injury claims. These windows vary and can be short. However, they are not the only timing rule that may apply. For example, some claims involving medical care follow separate procedural steps. An attorney can explain which rules govern your situation.
How Recalls Connect to Mass Tort Cases
Recalls sometimes become evidence in later litigation. They can document what a company knew and when. They can also identify affected lots and distribution ranges. For example, the 2021 Philips CPAP and BiPAP recall involved sound abatement foam degradation. Thousands of claims were later consolidated into multidistrict litigation. The recall notice served as a shared factual starting point.
The Takata airbag inflator recalls followed a similar path. Those recalls grew into one of the largest automotive safety actions in history. Litigation and settlements followed over several years. However, neither example predicts anything about the liebel-flarsheim optiray recall. No mass tort has been verified over this specific recall. Typically, litigation depends on documented injuries, not on the recall notice alone. As a result, a Class I designation signals regulatory seriousness, nothing more.
Frequently Asked Questions
What product is covered by the liebel-flarsheim optiray recall?
It covers Optiray Imaging Bulk Package-350, Ioversol Injection 74%, at 350 mg/mL organically bound iodine. The package is a 500 mL multiple-dose vial with NDC 0019-1333-65. Liebel-Flarsheim Company LLC manufactured it in Raleigh, North Carolina.
Why is this a Class I recall?
The FDA classified the liebel-flarsheim optiray recall as Class I because of particulate matter in the solution. The particles include polyethylene and other plastics, stainless steel, and glass. Class I means there is a reasonable probability of serious injury or death.
Have injuries been reported in this recall?
The FDA record does not state whether injuries have been reported. We will not claim either way. If you developed symptoms after a contrast imaging procedure, contact your physician and consider filing a MedWatch report.
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 August 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.