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FDA recall, , High risk

Optiray Imaging Bulk Package-350, Ioversol Injection 74%

Optiray Imaging Bulk Package-350 contains particulate matter including plastic and glass, which may cause local irritation or swelling.

Summary by Recall Canary from the FDA notice

What happened

Liebel-Flarsheim Company LLC, of Raleigh, North Carolina, recalled one lot of Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, because it contains particulate matter comprising polyethylene and other plastic materials, stainless steel and glass. The recall began on July 31, 2026, and was added to the FDA's Enforcement Report on August 12, 2026, then classified on August 19, 2026.

The product, manufactured by Liebel-Flarsheim Company LLC, was distributed nationwide in the US and Mexico. The recall was to the user level, including hospitals and imaging centers.

More foreign object recalls

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What to do

If a code on your package is listed below:

  1. Distributors, hospitals, healthcare facilities and clinics, and other healthcare providers that have the recalled product should immediately stop use and/or further distribution, quarantine all affected product inventory, and follow the instructions in the customer recall notification for arranging return of the affected lot to Liebel-Flarsheim Company, LLC.
  2. Contact your physician or healthcare provider if you have experienced any problems that may be related to using this drug product.
  3. Consumers with questions regarding this recall can contact Liebel-Flarsheim Company, LLC.
  4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm.

Is yours affected?

Match the lot code, best-by or expiration date and NDC listed under your product.

An NDC (National Drug Code) is usually printed on the drug's label.

  1. Optiray Imaging Bulk Package (IBP) 350, 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml) Multiple -Dose Container. Packaged in cases of 6 vials

    NDC
    • 0019-1333-65
    Lot code
    • 25ZF3670
    Best-by or expiration date
    May 31, 2027

Recall details

Company began the recall
Sold in

Distributed Nationwide in the US and Mexico.

Company
Liebel-Flarsheim Company LLCRaleigh, North Carolina
Hazard
Foreign object
Risk

High risk

There is a reasonable chance that taking it could cause serious health problems or death.

FDA Class I recall · How risk is rated

Event ID
99510
Recall number
D-0773-2026
Quantity recalled
3,486 500mL-vials

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall · Announced by the company

  2. Listed on Recall Canary

  3. Added to FDA's Enforcement Report

  4. Classified by FDA · In FDA's weekly enforcement report

  5. Summary updated

Other foreign object recalls

See all: Other foreign object recalls

Summary by Recall Canary, written with AI · summary updated Oct 7, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)