Optiray Imaging Bulk Package-350, Ioversol Injection 74%,… was recalled on July 31, 2026 in cooperation with the U.S. Food and Drug Administration because presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass..
Optiray 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-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.
Lot # 25ZF3670, Exp Date: May 31, 2027.
Units affected: 3,486 500mL-vials
Where it was sold: Distributed Nationwide in the US and Mexico.
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Class I is the most serious FDA recall level: using or being exposed to the product could cause serious health problems or death.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Liebel-Flarsheim Company LLC
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Content Uniformity Specifications
Failed Impurities/Degradation Specifications
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