Optiray Imaging Bulk Package-350 74% Recall: Particulate Matter
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Optiray Imaging Bulk Package-350 74% recalled?
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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.
Which lot codes, UPCs or models are affected?
Lot # 25ZF3670, Exp Date: May 31, 2027.
- Agency record number
- D-0773-2026
- Product
- Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution…
- Recalling firm
- Liebel-Flarsheim Company LLC
- Quantity
- 3,486 500mL-vials
- Distribution
- Distributed Nationwide in the US and Mexico.
- Recall started
- July 31, 2026
- Report date
- August 19, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (drug)