OPTIRAY
Recalling Firm / Manufacturer: Liebel-Flarsheim Company LLC
(Raleigh, NC, United States)
FDA Recall Number: D-0773-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
OPTIRAY
Generic Name
IOVERSOL
Active Substance(s)
Ioversol
Administration Route
Intra-arterial
National Drug Code (NDC)
0019-1323
Total Quantity Recalled
3,486 500mL-vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class I
Current Action Status
Ongoing
FDA Enforcement Report Date
August 19, 2026
Firm Initiation Date
July 31, 2026
FDA Classification Date
Aug 19, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # 25ZF3670, Exp Date: May 31, 2027.
Distribution Information
Geographic scope of affected shipments
Distributed Nationwide in the US and Mexico.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
⚠️ Immediate Action Required — Patient Notice
According to official FDA guidelines for Class I recalls, patients using affected lots should stop taking this product immediately and contact their physician or pharmacist for an appropriate alternative. Do not dispose of medication until instructed by your pharmacy.
Healthcare Provider & Pharmacy Notice
Quarantine affected inventory immediately. Contact patients who were dispensed recalled lots to arrange replacement. Report any adverse reactions directly to the FDA MedWatch Safety Information Program.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0773-2026
Questo Retrieval Date: September 10, 2026 12:00 1789041611UTCC