Liebel-Flarsheim Company LLC recalls Optiray Imaging Bulk Package-350
- Recalling company
- Liebel-Flarsheim Company LLC
- 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Jul 31, 2026
- Reported
- Aug 19, 2026
- Distribution
- Distributed Nationwide in the US and Mexico.
- Status
- Ongoing
- Quantity
- 3,486 500mL-vials
- Lot / codes
- Lot # 25ZF3670, Exp Date: May 31, 2027.
- Company location
- Raleigh, NC
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0773-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0773-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.