FDAFDA recall D-0773-2026 · Aug 19, 2026
Liebel-Flarsheim Company LLC: Optiray Imaging Bulk Package-350 recall
Recall found
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 for recall
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Lot # 25ZF3670, Exp Date: May 31, 2027.
- Quantity
- 3,486 500mL-vials
- Distribution
- Distributed Nationwide in the US and Mexico.
- Recalling firm
- Liebel-Flarsheim Company LLC, Raleigh, NC
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-31
Source: openFDA enforcement record D-0773-2026 · search recall number D-0773-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.