Why it was recalled
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # 25ZF3670, Exp Date: May 31, 2027.
Where it was sold
Distributed Nationwide in the US and Mexico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0773-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jul 31, 2026
- FDA report date
- Aug 19, 2026
- Quantity
- 3,486 500mL-vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Liebel-Flarsheim Company LLC
Original FDA data
Every field from FDA enforcement report D-0773-2026, exactly as published.
Show all FDA fields
- City
- Raleigh
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 99510
- Address
- 8800 Durant Rd
- Code information
- Lot # 25ZF3670, Exp Date: May 31, 2027.
- Postal code
- 27616-3104
- Report date
- Aug 19, 2026
- Product type
- Drugs
- Recall number
- D-0773-2026
- Classification
- Class I
- Recalling firm
- Liebel-Flarsheim Company LLC
- Product quantity
- 3,486 500mL-vials
- Reason for recall
- Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Distributed Nationwide in the US and Mexico.
- Recall initiation date
- Jul 31, 2026
- Initial firm notification
- Center classification date
- Aug 19, 2026