FDA Drug · D-0773-2026

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.

Class I · Ongoing

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

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Affected lots / codes — check yours against thisLot # 25ZF3670, Exp Date: May 31, 2027.
Recalling firm
Liebel-Flarsheim Company LLC, Raleigh, NC
Classification
Class I (most serious — risk of serious harm)
Status
Ongoing
Quantity
3,486 500mL-vials
Distribution
Distributed Nationwide in the US and Mexico.
Recall initiated
July 31, 2026
Classified
August 19, 2026
Initiation
Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0773-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →