Optiray Imaging Bulk Package-350 recall (Liebel-Flarsheim Company LLC)
DrugClass IOngoing
Summary: Liebel-Flarsheim Company LLC is recalling 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.
What is being recalled
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.
Why
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Distributed Nationwide in the US and Mexico.
How to tell if yours is affected
Lot # 25ZF3670, Exp Date: May 31, 2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0773-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | July 31, 2026 |
| Reported | August 19, 2026 |
| Company | Liebel-Flarsheim Company LLC |
| Company location | Raleigh, NC, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3,486 500mL-vials |
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