Quick answers
- What is Ioversol used for?
- The FDA-approved label (Optiray 320, Liebel-Flarsheim Company LLC, December 29, 2025) says: “OPTIRAY is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures Adults: Cerebral Arteriography (320 mg iodine/mL) Peripheral Arteriography (320, 350 mg iodine/mL ) Visceral and Renal Arteriography, Aortography (320 mg iodine/mL) Coronary Arteriography and Left Ventriculography (320, 350 mg iodine/mL) Pediatric Patients …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ioversol have a boxed warning?
- Yes. The FDA label for Optiray 320 has a boxed warning (“WARNING: NOT FOR INTRATHECAL USE”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Ioversol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ioversol been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started July 31, 2026 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Ioversol?
- 1 company lists prescription products of Ioversol in the FDA NDC Directory, including Liebel-Flarsheim Company LLC.
What Ioversol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
OPTIRAY is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures Adults: Cerebral Arteriography (320 mg iodine/mL) Peripheral Arteriography (320, 350 mg iodine/mL ) Visceral and Renal Arteriography, Aortography (320 mg iodine/mL) Coronary Arteriography and Left Ventriculography (320, 350 mg iodine/mL) Pediatric Patients …
— FDA label: Optiray 320, Liebel-Flarsheim Company LLC, effective December 29, 2025. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: NOT FOR INTRATHECAL USE
. Read it on the full label →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intra-arterial · Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Optiray 350, Optiray 320, Optiray 300 |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Liebel-Flarsheim Company LLC7 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019710 OPTIRAY 160, OPTIRAY 240, OPTIRAY 300, OPTIRAY 320, OPTIRAY 350 | Liebel-Flarsheim | December 30, 1988 | 39, latest April 25, 2023 2023: Labeling · 2022: Labeling · 2022: Labeling |
| NDA020923 OPTIRAY 240, OPTIRAY 300, OPTIRAY 320, OPTIRAY 350 | Liebel-Flarsheim | May 29, 1998 | 14, latest April 25, 2023 2023: Labeling · 2022: Labeling · 2020: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 31, 2026 · Class I · Ongoing · D-0773-2026
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
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 i — Liebel-Flarsheim Company LLC
-
September 13, 2019 · Class II · Terminated · D-0137-2020
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Com — GUERBET LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| SPL set ID of the quoted label | 6cb6ca5f-b249-49b0-a9eb-8aa583da7c74 |
|---|---|
| FDA labels (SPL) | 3 |
| FDA applications | NDA019710, NDA020923 |
| Active ingredients (FDA) | IOVERSOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Optiray 320, Liebel-Flarsheim Company LLC, effective December 29, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →