Recall archive / FDA drug enforcement

Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vi... — FDA record D-0773-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 31, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Classification: Class I
Recalling firm: Liebel-Flarsheim Company LLC
Quantity: 3,486 500mL-vials
Agency-reported status: Ongoing
Source record identifier: D-0773-2026

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What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot # 25ZF3670, Exp Date: May 31, 2027.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Distributed Nationwide in the US and Mexico.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Aug 19, 2026
Recall initiation date: Jul 31, 2026
Center classification date: Aug 19, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.