FDA-Drug2026-08-19Class IPACKAGING DEFECT
Liebel-Flarsheim Optiray ioversol injection recalled for particulate contamination
What this means
Liebel-Flarsheim Company LLC is recalling Optiray Imaging Bulk Package-350 (ioversol injection 74%, 350 mg/mL) due to the presence of particulate matter—including plastic, stainless steel, and glass—found in affected vials. The contamination affects lot #25ZF3670 with an expiration date of May 31, 2027, distributed nationwide in the US and Mexico.
- Check your facility's inventory for lot #25ZF3670 of Optiray 350 mg/mL vials.
- Do not use affected vials; quarantine them immediately.
- Contact Liebel-Flarsheim or your healthcare provider for guidance on replacement or proper disposal.
The agency's original wording
Hazard
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distributed Nationwide in the US and Mexico.
Affected count
3,486 500mL-vials
Manufactured in
8800 Durant Rd, Raleigh, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0773-2026Want us to check the next one for you?
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