Prescription medicine
Iohexol Brand names: Omnipaque
Iohexol (Omnipaque) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the iohexol FDA label on DailyMed (effective April 7, 2026, GE Healthcare Inc.); the NDA 18956 record on Drugs@FDA; every iohexol label on DailyMed.
Highlights of the record
FDA label of April 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION 140.
mg IODINE/mL and 350 mg IODINE/mL Use only the OMNIPAQUE iodine concentrations and presentations recommended for intrathecal procedure [see Dosage and Administration (2.2 , 2.8) ]. Intrathecal administration of OMNIPAQUE of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions (5.1) ]. WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION 140 and 350 mg IODINE/mL Use only the iodine concentrations and presentations recommended for intrathecal procedures. Intrathecal administration of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.
Used for
From the label: indications and usageOMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients.
Forms and strengths
- 9 mg/ml
- 12 mg/ml
- 140 mg/ml
- 180 mg/ml
- 240 mg/ml
- 300 mg/ml
- 350 mg/ml
Injection (solution); solution.
On the market
- Earliest approval on file
- December 26, 1985 Omnipaque 140, Ge Healthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first November 13, 2025; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 1 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2012 1 Class I among all firms' recalls; latest March 24, 2026; 2 more by firms not listed as its makers
- FAERS reports
- 8,244 through July 30, 2026
What is iohexol used for?
From the label: indications and usageOMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. […]
FDA pharmacologic class: Radiographic Contrast Agent.
Source: FDA drug label (OMNIPAQUE), GE Healthcare Inc., effective April 7, 2026 (SPL set eee15ebe-d349-4497-acef-6abe7a8247fb), via openFDA; the full label on DailyMed
Is there a generic for iohexol (Omnipaque)?
The FDA approved the first generic iohexol on November 13, 2025. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists iohexol from 1 labeler under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1985 earliest approval on file
- 2025 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has iohexol been recalled?
The FDA's Enforcement Report lists 6 recalls naming iohexol since 2012: 1 Class I (the most serious), 5 Class II, 0 Class III; 2 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of iohexol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 24, 2026 | Class II | GE Healthcare Ireland Limited | Presence of particulate matter |
| December 1, 2022 | Class I | BayCare Integrated Service Center, LLC /dba BayCare Central … not a listed maker | Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL |
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical | Lack of Assurance of Sterility |
| October 29, 2018 | Class II | GE Healthcare Inc. Life Sciences | Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the … |
| May 21, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the iohexol label say about other medicines?
The iohexol label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Metformin | drug interactions | DRUG INTERACTIONS 7.1 Drug-Drug Interactions Metformin In patients with renal impairment, metformin can cause lactic acidosis. |
Source: FDA drug label (OMNIPAQUE), GE Healthcare Inc., effective April 7, 2026 (SPL set eee15ebe-d349-4497-acef-6abe7a8247fb), via openFDA; the full label on DailyMed
What do FAERS reports show for iohexol?
The FDA Adverse Event Reporting System holds 8,244 reports that list iohexol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 488 are coded as a death and 2,707 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other radiographic contrast agents
- the pharmacologic class, with prices and generics
- Iohexol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other