FDA Recall: OPTIRAY Imaging Bulk Package 350 Vials Contaminated with Particulate Matter
Liebel-Flarsheim Company, LLC has issued an urgent nationwide recall of one lot of OPTIRAY Imaging Bulk Package (IBP) 350 mg Iodine /mL 500 mL vials after testing detected plastic, stainless steel, and glass particles in the solution. Patients injected with contaminated OPTIRAY contrast face risks ranging from local irritation to life-threatening emboli. If your facility stocks this contrast agent, stop using it, quarantine the lot, and arrange a return immediately.
OPTIRAY 350 Recall Details and Affected Lot
- Product: OPTIRAY IBP 350 (Ioversol Injection 74 %), 500 mL multiple-dose vial
- NDC: 0019-1333-65
- Affected Lot: 25ZF3670
- Expiration: 31 May 2027
- Distribution Area: United States & Mexico (hospitals, imaging centers, clinics)
- Recall Announced: 31 July 2026 | FDA Posted: 04 August 2026
- Reason for Recall: Presence of particulate matter (polyethylene, other plastics, stainless steel, glass)
Sources
Health Risks From Contaminated OPTIRAY Injections
Injecting a solution that contains foreign particles can trigger:
- Localized swelling, inflammation, or irritation at the injection site
- Blockage of blood vessels that may lead to tissue ischemia
- Formation of blood clots—an especially serious complication in high-risk patients
No injuries or adverse events have been reported to date, but the manufacturer and the FDA advise immediate action to prevent potential harm.
Required Actions for Healthcare Facilities
- Immediately cease use and distribution of OPTIRAY lot 25ZF3670.
- Quarantine all remaining inventory of the affected lot.
- Follow the instructions in the customer recall notice to arrange return and replacement with Liebel-Flarsheim Company, LLC.
- Report any adverse events to the FDA MedWatch program (details below).
Recall & Medical Contact Information
- Recall Processor (Inmar Inc.): +1-855-670-3976 | rxrecalls@inmar.com
- Medical Information: medical.liaison.na@guerbet.com
- Pharmacovigilance / Adverse Event Reporting: pvreporting@guerbet.com
How to Report OPTIRAY-Related Side Effects to FDA MedWatch
Healthcare professionals and patients can report product quality problems or side effects via:
- Online: FDA MedWatch Reporting
- Mail or Fax: Download Form FDA 3500 at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088.
Lot & Package Identification Guide
| Product | NDC | Lot | Expiration |
|---|---|---|---|
| OPTIRAY IBP 350, 500 mL vial (6-vial case) | 0019-1333-65 | 25ZF3670 | 31-May-2027 |
Official FDA Recall Image
Frequently Asked Questions About the OPTIRAY 350 Recall
- Why was OPTIRAY Imaging Bulk Package 350 recalled?
- The recalled lot contained particulate contaminants (plastic, stainless steel, and glass) that could cause serious injection-related injuries.
- Which lot of OPTIRAY Imaging Bulk Package 350 is affected by the FDA recall?
- Only lot 25ZF3670 (NDC 0019-1333-65) with an expiration date of 31 May 2027 is under recall.
- Is it safe to use OPTIRAY Imaging Bulk Package 350 from other lots?
- Yes. The manufacturer confirms no other OPTIRAY IBP 350 lots are impacted, but all vials should be visually inspected before use.
- What should healthcare facilities do with recalled OPTIRAY IBP 350 vials?
- Stop using them immediately, quarantine the inventory, and follow the recall notice to return the product for replacement or credit.
- Have any injuries been reported from OPTIRAY Imaging Bulk Package 350 lot 25ZF3670?
- No adverse events linked to this specific OPTIRAY lot have been reported as of 04 August 2026.
- How do I report an adverse event related to OPTIRAY Imaging Bulk Package 350?
- Submit a report to FDA MedWatch online or by mail/fax using Form FDA 3500; full instructions are provided in the “How to Report” section above.
- Can patients receive imaging studies with other OPTIRAY concentrations while this lot is recalled?
- Yes. Other OPTIRAY concentrations or lots not included in the recall may be used per usual practice, provided they pass visual inspection and institutional quality checks.