Class I

Drug Recall: 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, Ralei

Liebel-Flarsheim Company LLC · July 31, 2026

Reason for Recall

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Product Description

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.

Distribution

Distributed Nationwide in the US and Mexico.

States Affected

NATIONWIDE

Quantity Affected

3,486 500mL-vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0773-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Liebel-Flarsheim Company LLC Drug Recall: 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, Ralei | SafeCheck