CLASS I ONGOING Drug recall · Reported 19 Aug 2026 · FDA Enforcement Report
Optiray Imaging -350, Ioversol Injection recalled
Liebel-Flarsheim is recalling Optiray Imaging -350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, distributed nationwide in the US. The recall was initiated on 31 Jul 2026 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0773-2026
- FDA event ID
- 99510
- Recalling firm
- Liebel-Flarsheim, Raleigh, NC
- Brand
- Optiray
- Manufacturer
- Liebel-Flarsheim Company LLC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 31 Jul 2026
- FDA classified
- 19 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 31 Jul 2026 | Recall initiated by company | |
| 19 Aug 2026 | Classified by FDA | +19 days |
| 19 Aug 2026 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Product as listed by the FDA
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.
Where it was distributed
Distributed Nationwide in the US and Mexico.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Which lots are affected?
Lot # 25ZF3670, Exp Date: May 31, 2027.
Where was it sold?
Distributed Nationwide in the US and Mexico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Liebel-Flarsheim
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HydraVision Digital Imaging System Product ID recalled | Liebel-flarsheim | Device Malfunction | Nationwide |
| Device | CLASS II | Hydra Vision Urology X-Ray System recalled by Liebel-flarsheim Company | Liebel-flarsheim | Device Malfunction | 30 states |
| Device | CLASS II | Direct Digital Imaging System recalled by Liebel-flarsheim Company | Liebel-flarsheim | Device Malfunction | 30 states |
Other Ioversol recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Optiray 320 (ioversol) Injection recalled by GuerbetOptiray | Guerbet | Packaging Defects | Nationwide |