Recall RadarOptiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarshe…
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Read the official FDA notice →What to do
Stop using the product and check it against the description above. This recall is in the most serious category, meaning the agency believes it can cause serious injury or death — don't finish the package or use up what's left. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Liebel-Flarsheim Company LLC — Raleigh, NC
- Severity
- Class I — serious
- Reported
- August 19, 2026
- Quantity
- 3,486 500mL-vials
- Recall number
- D-0773-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Distributed Nationwide in the US and Mexico.
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