Official recall notice
FDA DrugClass INotable
OPTIRAY Imaging Bulk Package 350 Recall (Aug 2026)
Product: OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml); 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.
Why it was recalled
Hazard
Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass
Product description
Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass
Affected products
Lot # 25ZF3670, Exp Date: May 31, 2027.