What was recalled
The U.S. Food and Drug Administration (FDA) has issued a Class I recall involving a specific medical imaging product distributed by Liebel-Flarsheim Company LLC. This is not a broad alert affecting an entire line of medications, but rather a targeted withdrawal of one particular bulk package used in clinical settings. The product in question is the Optiray Imaging Bulk Package-350, which contains Ioversol Injection at a concentration of 74%, or 350 mg/mL of Organically Bound Iodine. These vials are designed as sterile, multiple-dose solutions intended for prescription use only, typically employed to enhance visibility during diagnostic imaging procedures such as computed tomography (CT) scans.
To ensure you can identify whether your facility or pharmacy is holding the affected inventory, it is crucial to look at the specific labeling details. The recalled item is a 500 mL multiple-dose vial manufactured by Liebel-Flarsheim Company LLC, located in Raleigh, North Carolina. The product was made in the USA and carries the National Drug Code (NDC) number 0019-1333-65. Most importantly, this recall applies exclusively to Lot Number 25ZF3670, which has an expiration date of May 31, 2027. If your stock does not match this exact lot number, it is not part of this specific safety alert.
The scope of this distribution was significant, with the affected units distributed nationwide within the United States as well as into Mexico. The recall was initiated on July 31, 2026. It is important to note that while the FDA classifies this as a Class I recall—the highest level of seriousness—this classification reflects the potential for serious adverse health consequences or death if the product is used without addressing the issue, rather than indicating that every single vial has caused harm. The remedy for this situation has not been explicitly stated in the initial recall facts, meaning healthcare providers and patients should contact the manufacturer or distributor directly for instructions on how to return or dispose of the product safely.
Understanding the specifics of what was recalled helps prevent unnecessary panic while ensuring that medical professionals take immediate action. The distinction between this specific bulk package and other Optiray products is vital, as only the vials with the identified lot number are subject to this recall. Healthcare facilities should immediately audit their inventory systems to isolate Lot 25ZF3670 from usable stock to prevent accidental administration.
The hazard, explained
At the heart of this FDA Class I recall is a serious physical contamination issue within the sterile solution itself. The Uoversay Imaging Bulk Package-350, manufactured by Liebel-Flarsheim Company LLC in Raleigh, North Carolina, has been found to contain particulate matter that should not be there. These unwanted particles are not microscopic impurities; they are tangible fragments made of polyethylene and other plastic materials, as well as pieces of stainless steel and glass. Because Optiray is an injectable contrast medium used for medical imaging procedures, the integrity of its fluid is paramount. The presence of these solid foreign objects compromises that integrity in a way that can have immediate and severe consequences for patients.
To understand why this is so dangerous, it helps to look at how the drug is administered. Optiray Ioversol Injection 74% is designed to be injected into the body, often directly into veins, arteries, or around the spinal column, to make internal structures visible during X-rays, CT scans, and other diagnostic tests. When a needle delivers a solution containing sharp or irregular fragments like glass shards or stiff plastic bits, those particles travel with the flow of blood or cerebrospinal fluid. Instead of dissolving or passing harmlessly through the body, these solids can lodge in small blood vessels, block capillaries, or physically damage delicate tissues.
The specific materials involved—stainless steel and glass—are particularly concerning because they are rigid and non-biodegradable. Stainless steel fragments, likely originating from manufacturing equipment or vial components, can act like tiny shrapnel within the circulatory system. Glass particles pose a risk of mechanical trauma to vessel walls, potentially leading to inflammation, clot formation, or embolisms. Polyethylene and other plastic materials, while perhaps less sharp than glass, are still foreign bodies that the immune system may react to, causing inflammation or granuloma formation. In the context of an injection, even small particles can cause significant blockages in microcirculation, cutting off blood supply to tiny areas of tissue.
This type of contamination is classified as a Class I recall by the FDA because it represents a situation where there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. The hazard is not just about the drug failing to work; it is about the drug itself becoming a source of injury. When injected, these particulates bypass the body’s natural filtration systems in the lungs and liver that might catch larger particles from oral medications. Direct injection places these contaminants exactly where they can do the most structural damage, making the physical presence of these foreign materials a critical safety failure.
Who is most at risk
To understand who faces the greatest danger from this recall, we first need to look at what Optiray actually is and how it is used. This product is not a medication you take at home for a minor ailment; it is a contrast agent administered by medical professionals during diagnostic imaging procedures, such as CT scans or angiograms. The active ingredient, ioversol, helps make blood vessels and organs visible on X-ray images. Because this is an Rx only sterile solution used in clinical settings, the general public does not carry these vials in their medicine cabinets. Therefore, the primary group "at risk" here is not someone who accidentally drank a bottle of contrast dye at home, but rather patients currently undergoing or scheduled for medical imaging tests at hospitals, outpatient clinics, and diagnostic centers across the United States and Mexico.
The specific hazard identified by the FDA involves the presence of particulate matter—tiny fragments of polyethylene plastic, stainless steel, and glass—within the vials. For a healthy adult receiving a single dose in a controlled hospital environment, the immediate risk might be manageable if medical staff catch it before administration. However, the risk profile shifts dramatically for vulnerable patient populations who are already compromised by illness or age. When particulate matter enters the bloodstream through an injection, it can cause embolisms (blockages in blood vessels), inflammation, or tissue damage at the site of injection. For patients with existing cardiovascular issues, diabetes, or weakened immune systems, even a small amount of foreign material can trigger severe complications that their bodies cannot easily filter out.
Elderly patients and those with chronic kidney disease are particularly vulnerable in this context. Contrast agents are processed by the kidneys, and any additional trauma from particulate contamination can exacerbate renal stress. Furthermore, the "Multiple-Dose" nature of the 500 mL vial means that if a single vial is contaminated, multiple patients could potentially be exposed during a busy shift at a hospital or clinic. This creates a broader risk pool beyond just the individual patient who receives the specific lot number 25ZF3670. While the recall date of July 31, 2026, suggests this is a future-dated scenario for our current timeline, the principle remains: any person receiving an injection from a vial manufactured by Liebel-Flarsheim Company LLC in Raleigh, NC, during that period is potentially exposed to these microscopic hazards.
It is also important to note that while the distribution pattern includes Mexico, the strictest oversight and reporting mechanisms are primarily documented for U.S. facilities. Patients receiving care in cross-border clinics or traveling between the two countries may face challenges in tracing whether their specific dose came from a recalled batch. Therefore, anyone who has undergone imaging procedures involving Optiray Imaging Bulk Package-350 around the time of this recall should proactively verify with their healthcare provider which lot number was used, rather than assuming safety based on general product knowledge.
- Patients undergoing CT scans or angiograms: Those who received ioversol contrast during the affected timeframe are the primary group needing verification.
- Vulnerable individuals: Elderly patients, those with heart conditions, or compromised immune systems face higher risks from particulate embolisms.
- Multiple-dose exposure: Because the vial holds 500 mL, one contaminated container could theoretically affect several patients in a single clinical setting.
How to tell if you have the recalled item
Because this recall involves a specific pharmaceutical product distributed for medical use, identifying the affected items requires careful attention to the details printed on the vial’s label. You cannot rely on general appearance or color alone, as medical supplies can look similar across different brands and formulations. Instead, you must verify the unique identifiers that link the physical object to the FDA’s official record. The first step is to locate the National Drug Code (NDC) number, which serves as a unique product identifier for prescription drugs in the United States. For this specific recall, you are looking for NDC 0019-1333-65. This code is typically printed prominently on the label of the vial. If your supply does not match this exact NDC sequence, it is likely not part of this particular recall event, though you should always verify with a pharmacist if there is any doubt.
Next, check the lot number and the expiration date, which are critical for determining whether your specific batch is affected. The recall applies exclusively to Lot # 25ZF3670. Lot numbers are usually found near the NDC or on a separate sticker applied by the distributor. Alongside the lot number, confirm the expiration date is May 31, 2027. It is important to note that while the expiration date helps confirm the product’s timeline, it is the combination of the correct NDC and the specific Lot # that definitively identifies the recalled items. If you have a vial with a different lot number, even if it has the same expiration date, it is not included in this recall action.
You should also verify the product name and manufacturer details to ensure you are dealing with the correct item. The recalled product is the Optiray Imaging Bulk Package-350, specifically Ioversol Injection 74%, containing 350 mg/mL of Organically Bound Iodine. It is packaged as a 500 mL Multiple-Dose Vial. The manufacturer listed on the label should be Liebel-Flarsheim Company LLC, located in Raleigh, NC. Additionally, check for indications that the product was made in the USA. While this item was distributed nationwide in the US and Mexico, physical location of purchase does not determine eligibility; only the lot number and NDC matter. If you are a patient or healthcare provider holding such a vial, do not use it until you have confirmed these details against the official recall notice.
- Product Name: Optiray Imaging Bulk Package-350, Ioversol Injection 74%
- NDC Number: 0019-1333-65
- Lot Number: 25ZF3670
- Expiration Date: May 31, 2027
- Manufacturer: Liebel-Flarsheim Company LLC, Raleigh, NC
What to do — step by step
If you or a healthcare provider are involved with the specific Lot # 25ZF3670 of Optiray Imaging Bulk Package-350 (Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial) manufactured by Liebel-Flarsheim Company LLC, the immediate priority is safety and verification. Because the official recall facts provided do not explicitly state a remedy such as a direct return process, refund instructions, or a specific repair protocol, you must rely on standard medical safety protocols for Class I drug recalls involving particulate contamination. A Class I classification indicates a situation where there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. Therefore, the steps below are designed to ensure that no contaminated vials enter the patient stream and to guide you through the necessary administrative actions.
Step 1: Immediately Cease Use. If any vials from Lot # 25ZF3670 with an expiration date of May 31, 2027, are currently in your possession or in a clinical setting, stop using them immediately. Do not attempt to filter the solution or inspect it visually for particles, as polyethylene, plastic materials, stainless steel, and glass fragments may be microscopic and invisible to the naked eye. The presence of such particulate matter in an injection intended for imaging procedures poses a direct risk of embolism, tissue damage, or infection. Quarantine these vials in a secure area away from sterile supplies to prevent accidental administration.
Step 2: Verify Your Inventory. Carefully check all stock records, pharmacy logs, and radiology department inventories for the National Drug Code (NDC) 0019-1333-65. Confirm that you are looking at the exact lot number identified in the recall: 25ZF3670. Since this product was distributed nationwide in the United States and Mexico, records may be held by hospitals, imaging centers, clinics, or potentially in rare cases by individual patients who have previously purchased it for home use (though this is an Rx-only sterile solution). Document the quantity of affected units found.
Step 3: Contact Your Healthcare Provider or Supplier. Since the recall facts do not provide a specific consumer hotline or return address, you must contact the manufacturer, Liebel-Flarsheim Company LLC in Raleigh, NC, or your direct distributor. If you are a patient, inform the physician who ordered the imaging procedure. They will have access to professional recall notifications and can determine if they received this specific lot. If you are a healthcare facility, contact the medical device or pharmaceutical representative who supplied the product. Ask them for instructions on how to return the defective goods for destruction or credit, as manufacturers typically arrange for the safe disposal of Class I recalled drugs.
Step 4: Monitor for Adverse Events. If any of the recalled product was already administered prior to this notice, report it immediately. Look for symptoms related to foreign body reactions, such as unusual pain at the injection site, fever, swelling, or signs of an allergic reaction. Report these incidents to your healthcare provider and consider filing a MedWatch report with the FDA to help track potential health impacts.
Step 5: Secure Alternative Supplies. Work with your supplier to ensure that replacement products are verified as safe and do not share the same lot number or manufacturing defects. Ensure that all staff are aware of the recall to prevent any confusion during future procedures.
Your refund, repair, or replacement options
When a medical product is recalled, the most immediate concern for patients and healthcare providers alike is often: "What happens next?" In this specific case involving Liebel-Flarsheim Company LLC’s Optiray Imaging Bulk Package, the official recall notice from the Food and Drug Administration (FDA) does not explicitly state a standardized remedy such as a full refund, automatic replacement, or repair service. While this might feel unsettling, it is important to understand that Class I recalls, which represent the highest risk category, are primarily driven by the need to remove dangerous items from the supply chain immediately. The absence of a specific "refund or replace" instruction in the public filing does not mean you are without recourse; rather, it shifts the responsibility to direct communication with the manufacturer to resolve individual cases.
Because the recall involves a sterile injectable solution used for medical imaging, the standard path forward begins with contacting Liebel-Flarsheim Company LLC directly. The official records identify the manufacturer as located in Raleigh, North Carolina. Healthcare facilities, pharmacies, and clinicians who currently possess the affected lots should not attempt to use these vials under any circumstances. Instead, they must immediately quarantine the product to prevent accidental administration. To understand your specific options regarding compensation or replacement inventory, you will need to reach out to the company’s designated recall coordinator. While the general public filing does not list a specific toll-free number or email address, Liebel-Flarsheim is required by federal law to provide these contact details in their official recall communication. You should look for the "Contact Us" information on the official FDA recall press release or reach out to the company’s main corporate line in Raleigh, NC 27616, to request the specific recall team's direct contact information.
If you are a patient who has already received this medication, do not panic, but do act quickly. Since the remedy is not pre-defined as an automatic check or shipment, your healthcare provider must become your advocate. They will need to report any adverse events or potential exposure to the FDA’s MedWatch program and simultaneously contact Liebel-Flarsheim to document the incident. In many pharmaceutical recalls, manufacturers offer replacement stock for unused units to ensure continuity of care, but this is typically negotiated case-by-case when a specific remedy isn't broadly advertised. For those concerned about financial reimbursement, this usually requires a direct claim filed with the manufacturer’s quality assurance department after the recall is verified.
To facilitate this process, keep your records handy. You will need the National Drug Code (NDC) 0019-1333-65 and the specific Lot Number 25ZF3670 to prove you have the recalled item. Without these details, the manufacturer cannot verify your claim or offer a remedy. The expiration date for this lot is May 31, 2027, which confirms that the product was not expired but was defective due to particulate matter. By contacting Liebel-Flarsheim directly with these precise identifiers, you initiate the formal process of resolving your specific situation, whether that involves receiving a replacement sterile vial for medical use or processing a credit for the cost of the product.
What can happen if you ignore it
When a Class I recall is issued by the FDA, it signals the most serious category of potential health consequence. While the specific incident reports for this Liebel-Flarsheim recall do not detail confirmed injuries at this time, the nature of the hazard—particulate matter comprising polyethylene, other plastics, stainless steel, and glass—presents a direct and immediate physical threat to patients who rely on Optiray Imaging Bulk Package-350 for diagnostic procedures. Ignoring this recall is not merely a question of administrative compliance; it is a decision to expose a patient’s vascular system to foreign, non-soluble objects.
The primary danger lies in the mechanism of delivery. This product is an injection intended for intravascular use, meaning it is pumped directly into the bloodstream. If the vial contains visible particulate matter, those particles are not filtered out before entering the body. Unlike oral medications that pass through the digestive system, injected particulates travel immediately with the flow of blood. Small fragments of glass or stainless steel can cause mechanical damage to the delicate lining of blood vessels (endothelium) as they move through circulation. This physical trauma can trigger inflammation, clot formation, and blockages in critical pathways.
If these foreign particles are large enough, they can become lodged in smaller blood vessels, leading to embolisms. An embolism occurs when a blockage stops blood flow to vital tissues. Depending on where the particle travels, this can result in serious complications such as pulmonary embolism (blockage in the lungs), stroke (if particles travel to the brain), or organ damage in other parts of the body. Even microscopic plastic fragments can accumulate over time or trigger immune responses that lead to granulomas—small areas of inflammation that form when the body attempts to wall off foreign material it cannot break down.
Furthermore, the presence of these contaminants indicates a failure in the sterile manufacturing process. This raises concerns about sterility assurance. If particulate matter is present, there is a heightened risk that the seal integrity or filtration processes were compromised, potentially allowing bacterial contamination alongside the physical debris. Using a product with known particulate contamination increases the risk of sepsis or severe local infection at the injection site or systemically throughout the body.
For healthcare providers and patients alike, the stakes are high. Optiray is often used in critical diagnostic imaging where speed and accuracy are essential. Introducing a hazardous product into this process undermines the safety net that the medical procedure is supposed to provide. The consequence of ignoring the recall is not just a wasted vial; it is the potential for irreversible harm, extended hospital stays, additional invasive procedures to remove clots or damaged tissue, and in the worst-case scenarios, life-threatening events. The uncertainty of how many particles might be in any given 500 mL multiple-dose vial means that every use carries an unpredictable risk profile.
In summary, continuing to use this recalled lot ignores a clear signal of physical danger. The "wait and see" approach is medically unsound when the hazard involves solid objects entering the circulatory system. The potential outcomes range from minor inflammatory responses to catastrophic vascular blockages. Given that the remedy for such physical contamination is primarily prevention—avoiding entry into the body entirely—the only safe course of action is immediate discontinuation and proper disposal or return as directed by the manufacturer.
Staying safe: broader tips
While this specific recall addresses a manufacturing defect involving particulate matter in a specialized medical imaging agent, the underlying principle of vigilance applies to all pharmaceutical and medical products. The presence of foreign objects like plastic or glass in sterile solutions is a rare but serious quality control failure. For consumers and healthcare providers alike, staying protected means adopting a proactive relationship with product safety rather than a reactive one. One of the most effective ways to do this is by establishing a routine for monitoring official recall announcements. The U.S. Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC) maintain extensive databases that are updated daily. By subscribing to email alerts from these agencies, you ensure that critical safety information reaches your inbox before it becomes a widespread issue. This is particularly important for prescription medications, which often have complex distribution chains and may not be immediately flagged in local pharmacies.
When handling any injectable medication or sterile medical device, visual inspection is your first line of defense. Even with the best manufacturing standards, errors can occur during shipping or storage. You should always examine vials and packages for signs of tampering, such as broken seals, crushed boxes, or unusual swelling. For liquid medications, hold the container up to a light source and look for cloudiness, discoloration, or visible particles that do not dissolve upon gentle shaking. If anything appears amiss, trust your instincts and do not use the product. In a clinical setting, this practice is standard protocol, but it is equally vital for anyone managing home health care. Never assume that a product is safe simply because it has been in your possession for some time; expiration dates and storage conditions play a crucial role in maintaining sterility.
Furthermore, consider the importance of secure and proper storage environments. Many medical products are sensitive to temperature fluctuations, light exposure, and physical shock. Storing medications in their original packaging until use helps protect them from environmental hazards and makes it easier to read labels and lot numbers quickly during an emergency. Keep a digital or physical list of your current medications, including lot numbers and expiration dates, especially for high-risk items like injections. This record-keeping habit not only aids in managing your health but also speeds up the process if a recall is announced. Finally, maintain open lines of communication with your healthcare providers. Pharmacists and doctors are often the first to hear about emerging safety concerns within their professional networks. Asking them directly, "Are there any active recalls for my current medications?" during routine visits can provide peace of mind and ensure you are acting on the most current safety data available.