Optiray 350 Ioversol Injection
Liebel-Flarsheim recalls Optiray 350 Ioversol Injection 500 mL vials due to particulate matter (plastic, steel, glass).
If you have an affected Optiray 350 IBP 500 mL vial, stop using it immediately and contact Liebel-Flarsheim Company LLC for instructions on return and replacement. Do not administer the product if particulate matter is visible.
Recall at a glance
- Quantity recalled
- 3,486 500mL-vials
Why it was recalled
Liebel-Flarsheim Company LLC is recalling Optiray Imaging Bulk Package-350 (Ioversol Injection 74%, 350 mg/mL organically bound iodine) 500 mL multiple-dose vials due to the presence of particulate matter comprising polyethylene and other plastic materials, stainless steel, and glass. The affected product is a sterile, Rx-only solution used as a contrast agent for imaging procedures.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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
- Lot code
- 25ZF3670
- Best-by
- May 31, 2027
- NDC
- 0019-1333-65
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Foreign Material recalls
Editorial summary by Recall Canary · summary updated 2026-08-21 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification