🟡 Preliminary Evidence
The U.S. Food and Drug Administration (FDA) has issued a nationwide recall of one lot of OPTIRAY Imaging Bulk Package (IBP) 350, a contrast agent used in diagnostic imaging procedures, due to the presence of particulate matter, according to a recall notice released July 31, 2026. Liebel-Flarsheim Company, LLC, the manufacturer based in Raleigh, North Carolina, initiated the recall affecting 500 mL vials intended for intra-arterial or intra-venous use. The FDA statement does not specify the precise number of vials affected or report any confirmed patient injuries to date.
Key takeaways
- Liebel-Flarsheim Company, LLC recalls OPTIRAY 350 contrast agent due to particulate contamination in one specific lot
- The affected product is 500 mL vials of Ioversol Injection 74% (350 mg iodine/mL) intended for arterial or venous imaging
- Recall extends to hospitals and imaging centres across the United States and Mexico
- Healthcare facilities have been advised to cease use and quarantine affected inventory
Contrast Agent Recall Timeline and Scope
Geographic distribution and healthcare system impact, United States and Mexico, July 2026
Source: FDA Safety Alerts, July 2026 | Georgian Medical Journal News
Why Particulate Contamination Matters in Contrast Imaging
Particulate matter in radiographic contrast agents poses a direct clinical risk. Particles suspended in intravenous or intra-arterial injections can lodge in small blood vessels, potentially causing embolic events, vascular occlusion, or adverse reactions. The FDA’s quality standards for injectable pharmaceuticals require contrast agents to meet strict particulate specifications before distribution to healthcare facilities. A contaminated contrast agent bypassing quality control represents a breach in these essential safety protocols.
Ioversol, the active pharmaceutical ingredient in OPTIRAY, is a non-ionic contrast medium widely used in coronary angiography, cerebral angiography, and other vascular imaging procedures. The presence of undeclared particulate matter in a 500 mL bulk vial could affect multiple patient procedures if the contaminated lot was already in clinical use before the recall notice was issued. This makes rapid identification and quarantine of the affected inventory critical, as noted in the FDA’s July 31, 2026 alert.
Manufacturer Response and Clinical Distribution
Liebel-Flarsheim Company, LLC has notified hospitals, ambulatory surgical centres, and imaging facilities directly to halt use of the recalled lot and return or quarantine remaining vials. The FDA’s recall classification system designates this action as a direct patient care alert, requiring immediate response from all relevant healthcare providers. The recall affects both the United States and Mexico, indicating the contrast agent was distributed across North American supply chains.
The manufacturer’s level of distribution—specified as “user level” in FDA terminology—means the contaminated product reached end-users (hospitals and imaging centres) rather than being intercepted at the wholesale or distributor stage. This underscores the importance of lot-level tracking systems in pharmaceutical supply chains. Healthcare facilities that received this lot are advised to check their inventory records and verify lot numbers against the FDA’s recall identifier to ensure they have not inadvertently used the contaminated vials.
Liebel-Flarsheim Company, LLC is recalling one lot of OPTIRAY Imaging Bulk Package 350, 500 mL vials due to presence of particulate matter, affecting hospitals and imaging centres across the United States and Mexico.
— FDA Safety Alerts and Recalls, July 31, 2026
What this means
Ongoing Safety Monitoring
The FDA continues to monitor adverse event reports related to this recall through its MedWatch system. Healthcare providers are encouraged to report any complications potentially related to the recalled contrast agent. As of the July 31, 2026 announcement, the FDA’s statement does not indicate confirmed patient injuries, but the agency will update the public if new safety information emerges. Liebel-Flarsheim Company, LLC remains responsible for conducting a root cause analysis and implementing corrective measures to prevent similar contamination events in future manufacturing batches.
Institutions affected by this quality and safety recall should document their response procedures and maintain records of affected inventory for regulatory compliance. This incident underscores the critical importance of pharmaceutical supply chain integrity in diagnostic imaging and the need for continuous vigilance in detecting and responding to product defects before patient harm occurs.
Source: FDA Safety Alerts: Liebel-Flarsheim Company, LLC Issues Recall of OPTIRAY Imaging Bulk Package
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