Quick answers
- What is Iohexol used for?
- The FDA-approved label (Omnipaque, Medical Purchasing Solutions, LLC, April 28, 2026) says: “OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. 1.1 Intrathecal Procedures ‡ OMNIPAQUE is indicated for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Iohexol have a boxed warning?
- Yes. The FDA label for Omnipaque has a boxed warning (“WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Iohexol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Iohexol been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started March 24, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Iohexol?
- 4 companies list prescription products of Iohexol in the FDA NDC Directory, including GE Healthcare Inc., Amneal Pharmaceuticals Private Limited and Medical Purchasing Solutions, LLC.
What Iohexol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. 1.1 Intrathecal Procedures ‡ OMNIPAQUE is indicated for …
— FDA label: Omnipaque, Medical Purchasing Solutions, LLC, effective April 28, 2026. Read the full label on DailyMed →
The FDA has 5 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: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION
. Read it on the full label →
5 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Solution |
|---|---|
| Route | Intravenous · Oral · Intravascular · Intra-articular · Intrathecal · Rectal |
| Prescription products | 15 in the FDA NDC Directory |
| Brand names | Omnipaque |
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.
- GE Healthcare Inc.7 products
- Amneal Pharmaceuticals Private Limited6 products
- Medical Purchasing Solutions, LLC2 products
- GE Healthcare2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018956 OMNIPAQUE 12, OMNIPAQUE 140, OMNIPAQUE 180, OMNIPAQUE 210, OMNIPAQUE 240, OMNIPAQUE 300 | Ge Healthcare | December 26, 1985 | 67, latest October 8, 2024 2024: Labeling · 2023: Labeling · 2022: Labeling |
| NDA020608 OMNIPAQUE 240, OMNIPAQUE 300, OMNIPAQUE 350 | Ge Healthcare | October 24, 1995 | 16, latest October 8, 2024 2024: Labeling · 2023: Labeling · 2022: Labeling |
Generic approvals (1)
- ANDA217737Amneal · November 13, 2025
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.
-
March 24, 2026 · Class II · Ongoing · D-0448-2026
Presence of particulate matter
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91. — GE Healthcare Ireland Limited
-
March 24, 2026 · Class II · Ongoing · D-0447-2026
Presence of particulate matter
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63. — GE Healthcare Ireland Limited
-
October 29, 2018 · Class II · Terminated · D-0319-2019
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.; Manufactured by GE Healthcare AS, Oslo, — GE Healthcare Inc. Life Sciences
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 | 508c42eb-f5e5-44f1-e063-6294a90a4d1f |
|---|---|
| FDA labels (SPL) | 5 |
| FDA applications | NDA018956, NDA020608, 1 ANDA |
| Active ingredients (FDA) | IOHEXOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Omnipaque, Medical Purchasing Solutions, LLC, effective April 28, 2026; 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 →