FDA recall announcement
OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol recall 2026
Liebel-Flarsheim Company, LLC announced a recall of OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml). FDA lists the reason as: Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass
Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass
- FDA publish date
- August 4, 2026
- Company
- Liebel-Flarsheim Company, LLC
- Product
- OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)
- Last checked
- September 23, 2026
- NDC / identifier
- No specific identifier listed in this announcement
- Affected lot(s)
- No specific lot listed for this clarification
What the FDA announcement says
Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass
Read the original FDA recall announcement →
What to check on the package
- Confirm the exact product and brand name.
- Compare the manufacturer or distributor.
- Match the NDC or product identifier.
- Match the lot or code exactly; a drug name alone is not enough.
What to do
Do not stop or change a prescribed medication based only on this page. Contact a pharmacist, prescriber, or the recalling company for instructions specific to your product.
Related FDA enforcement records
1 matching record appear in the current 24-month openFDA snapshot. Use the search tool to compare the exact manufacturer, NDC, and lot.
Search all records for OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol →
Source and limitations
This server-rendered page summarizes an FDA source and the openFDA enforcement snapshot last checked on September 23, 2026. It is not an FDA service and does not provide individual medical advice.