Reported Aug 19, 2026 · Ongoing · Updated Sep 16, 2026

Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose…

Liebel-Flarsheim Company LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Liebel-Flarsheim Company LLC · 8800 Durant Rd · Raleigh, NC · 27616-3104

Is this the product you have?

    • Optiray Imaging Bulk Package-350
    • Ioversol Injection 74%
    • 350 mg/mL Organically Bound Iodine
    • 500 mL Multiple-Dose Vial
    • Rx only
    • Sterile Solution
  • Manufactured byLiebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65
Lot codes and dates
  • Lot # 25ZF3670
  • Exp Date
    • May 31
    • 2027
Amount recalled
3,486 500mL-vials

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Notice updated Aug 19, 2026 · Data as of Sep 19, 7:32 PM UTC

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