Liebel-Flarsheim Company, LLC Issues Recall of OPTIRAY Imaging Bulk Package - 350, 500mL, Vial, Nationwide and Mexico Due to Presence of Particulate Matter

FDA recall notice · announced July 31, 2026 · Liebel-flarsheim

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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.

Reason for recall

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

Notes

Distribution: Distributed Nationwide in the US and Mexico.
Lot/code information: Lot # 25ZF3670, Exp Date: May 31, 2027.
Quantity: 3,486 500mL-vials
Status: Ongoing
Products in this recall event:
- 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 (D-0773-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.