Quick answers
- What is Sodium iodide i 131 used for?
- The FDA-approved label (Hicon, Jubilant DraxImage Inc., dba Jubilant Radiopharma, January 21, 2025) says: “HICON ® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. HICON ® is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sodium iodide i 131 have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sodium iodide i 131?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sodium iodide i 131 been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 11, 2016 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Sodium iodide i 131?
- 1 company lists prescription products of Sodium iodide i 131 in the FDA NDC Directory, including Jubilant DraxImage Inc., dba Jubilant Radiopharma.
What Sodium iodide i 131 is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
HICON ® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. HICON ® is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
— FDA label: Hicon, Jubilant DraxImage Inc., dba Jubilant Radiopharma, effective January 21, 2025. Read the full label on DailyMed →
The FDA has 2 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.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Capsule |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Hicon, Sodium Iodide I 131 Diagnostic |
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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021305 HICON, SODIUM IODIDE I 131 | Jubilant | January 24, 2003 | 20, latest June 11, 2021 2021: Labeling · 2016: Labeling · 2016: 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.
-
March 11, 2016 · Class III · Terminated · D-0812-2016
Labeling: Label Error on Declared Strength
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05 — Jubilant Draximage Inc
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 | 524a0dac-6e2b-2c0c-04b4-76d85dba63c5 |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | NDA021305 |
| Active ingredients (FDA) | SODIUM IODIDE I-131 |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Hicon, Jubilant DraxImage Inc., dba Jubilant Radiopharma, effective January 21, 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 →