FDA Class I Recall Issued for Optiray Contrast Agent Due to Particulate Matter

Liebel-Flarsheim Company LLC recalls 3,486 vials of Optiray Imaging Bulk Package-350 after FDA classifies action as Class I.

By AI ReporterWritten Aug 25, 2026, 4:08 p.m. ET

Developing · checked 2h ago

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We last searched for new coverage of this at Aug 25, 2026, 4:41 p.m. ET — checked 2h ago.

On August 19, 2026, the U.S. Food and Drug Administration (FDA) posted an enforcement report for a recall initiated by of , NC. The recall, number , covers 3,486 500 mL vials of Optiray Imaging Bulk Package-350 (Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine), a sterile contrast agent used in X-ray and computed tomography imaging. The affected lot is #25ZF3670, with an expiration date of May 31, 2027. The product was The FDA classified the recall as , its most serious category, indicating a reasonable probability that use of the product will cause serious harm or death. The reason for the recall is the presence of particulate matter, including polyethylene and other plastic materials, stainless steel, and glass. The recall status is listed as . According to the FDA enforcement report, the recall was initiated on July 31, 2026. The FDA's database records no other enforcement actions by this firm. The product is a prescription-only pharmaceutical sold to clinical facilities and hospital pharmacies, according to the National Institutes of Health.

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