Quick answers
- What is Omnipaque?
- Omnipaque is a brand name of Iohexol, a prescription medicine. The FDA NDC Directory lists 9 Omnipaque products in 8 strengths and forms.
- Who makes Omnipaque?
- Ge Healthcare holds the FDA application for Omnipaque (NDA018956, approved December 26, 1985). 2 other companies (repackagers or distributors) also list Omnipaque products.
- Is there a generic or store brand of Omnipaque?
- Yes. The FDA NDC Directory lists 9 other products with the same active ingredients, strength and form as a Omnipaque product, 9 of them generic. Ask your pharmacist whether one is right for you.
- Has Omnipaque been recalled?
- FDA enforcement reports list 3 recalls of Omnipaque products; the newest started March 24, 2026. A recall usually concerns specific lots, not every product.
What Omnipaque is
Each Omnipaque product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Iohexol · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| iohexol 12 mg/mL solution (oral) | Omnipaque | None listed | DailyMed |
| iohexol 140 mg/mL injection, solution (intravascular, intravenous) | Omnipaque | None listed | DailyMed |
| iohexol 180 mg/mL injection, solution (intrathecal, oral, rectal) | Omnipaque | None listed | DailyMed |
| iohexol 240 mg/mL injection, solution (intra-articular, intrathecal, intravascular, intravenous, oral, rectal) | Omnipaque | None listed | DailyMed |
| iohexol 300 mg/mL injection, solution (intravenous) | Omnipaque | 3 products, 1 company | DailyMed |
| iohexol 300 mg/mL injection, solution (intra-articular, intrathecal, intravascular, intravenous, oral, rectal) | Omnipaque | 3 products, 1 company | DailyMed |
| iohexol 350 mg/mL injection, solution (intra-articular, intravascular, intravenous, oral) | Omnipaque | 3 products, 1 company | DailyMed |
| iohexol 9 mg/mL solution (oral) | Omnipaque | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Iohexol →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA018956 | Ge Healthcare | December 26, 1985 | 8 |
| NDA020608 | Ge Healthcare | October 24, 1995 | 1 |
Companies that list Omnipaque
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Omnipaque products.
- GE Healthcare Inc.6 products
- Medical Purchasing Solutions, LLC2 products
- GE Healthcare1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: 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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.