Class IDrug
Optiray Imaging Bulk Package-350 recall
Summary
Liebel-Flarsheim Company LLC is recalling Optiray Imaging Bulk Package-350 (drug). According to the FDA report, the reason is: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. The FDA rated this a Class I: most serious: there is a reasonable chance the product could cause serious health problems or death. Recall status: Ongoing.
Understanding this recall
What happened
Liebel-Flarsheim is recalling Optiray 350 (ioversol injection) imaging bulk packages because particles including plastics, stainless steel and glass were found.
Why it matters
Medicines given by injection or IV go straight into the bloodstream, so they must be free of visible and sub-visible particles. Particles such as glass, metal or plastic in an injectable can, in principle, block small blood vessels or cause irritation, inflammation or clots. That risk is why the FDA treats particulate matter in injectables seriously.
Who should pay attention
Radiology and imaging departments that use Optiray contrast media.
Distribution in the FDA report: Distributed Nationwide in the US and Mexico.
How to check your product
Check the lot number and expiration date on the vial.
Codes listed by the FDA: Lot # 25ZF3670, Exp Date: May 31, 2027.
Based only on the FDA enforcement record plus general public-health background on this type of hazard. Not medical advice; if you have symptoms or concerns, contact a doctor or pharmacist.
Details from the FDA report
- 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.
- Lot / code info
- Lot # 25ZF3670, Exp Date: May 31, 2027.
- Quantity
- 3,486 500mL-vials
- Distribution
- Distributed Nationwide in the US and Mexico.
- Recalling company
- Liebel-Flarsheim Company LLC, Raleigh, NC United States
- Recall started
- July 31, 2026
- FDA report date
- August 19, 2026
- Classification
- Class I: Most serious: there is a reasonable chance the product could cause serious health problems or death.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0773-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Liebel-Flarsheim Company LLC) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.