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D-0773-2026Class I

Liebel-Flarsheim Company LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Liebel-Flarsheim Company LLC
Product type
Drug
Status
Ongoing
Report date
2026-08-19
Distribution
Distributed Nationwide in the US and Mexico.
Firm state
NC
Product quantity
3,486 500mL-vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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.

Code / lot info

Lot # 25ZF3670, Exp Date: May 31, 2027.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →