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Class IOngoing

Liebel-Flarsheim Company LLC recalls Optiray Imaging Bulk Package-350

Recall date · record updated Aug 19, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Liebel-Flarsheim Company LLC
Reason
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Hazard
FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
Who’s affected
Distributed Nationwide in the US and Mexico.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99510…

Products

  1. 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.

    Codes/lots: Lot # 25ZF3670, Exp Date: May 31, 2027.Quantity: 3,486 500mL-vialsRecall no. D-0773-2026Class I

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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