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Prescription medicine

Ethiodized oil

Brand names: Lipiodol

Drug class: Radiographic Contrast Agent

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
1Companies
1954First FDA approval on file

Quick answers

What is Ethiodized oil used for?
The FDA-approved label (Lipiodol, Guerbet LLC, December 16, 2025) says: “Lipiodol is an oil-based radio-opaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC) Lipiodol is an oil-based radiopaque contrast agent indicated for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Ethiodized oil have a boxed warning?
Yes. The FDA label for Lipiodol has a boxed warning (“WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Ethiodized oil?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Ethiodized oil been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Ethiodized oil?
1 company lists prescription products of Ethiodized oil in the FDA NDC Directory, including Guerbet LLC.

What Ethiodized oil is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Lipiodol is an oil-based radio-opaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC) Lipiodol is an oil-based radiopaque contrast agent indicated for …

— FDA label: Lipiodol, Guerbet LLC, effective December 16, 2025. Read the full label on DailyMed →

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: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY. Read it on the full label →

Forms and how it is given

Dosage formsInjection
RouteIntra-arterial · Intralymphatic · Intrauterine
Prescription products1 in the FDA NDC Directory
Brand namesLipiodol

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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA009190
LIPIODOL		 GuerbetMarch 31, 1954 11, latest April 5, 2023
2023: Labeling · 2020: Labeling · 2020: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

SPL set ID of the quoted label511d1f64-5cb9-4baa-a123-96205467e59a
FDA labels (SPL)1
FDA applicationsNDA009190
Active ingredients (FDA)ETHIODIZED OIL

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Lipiodol, Guerbet LLC, effective December 16, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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