RecallRadar
ModerateReported March 11, 2026

Sodium Iodide (I-131) Solution, Therapeutic Oral

Recalled by Radnostix

Product image for Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392.  (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477.  (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
Product image via DailyMed (National Library of Medicine). It may show general packaging and not the exact recalled lot — always confirm using the codes below.

Class II — moderate

Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Radnostix has recalled Sodium Iodide (I-131) Solution, Therapeutic Oral, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on March 11, 2026 and was initiated on January 26, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Sodium Iodide (I-131) Solution, Therapeutic Oral, with approximately 16 units affected. The company behind the recall is Radnostix, based in Idaho Falls, ID. The FDA describes the product as: “Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC…”

Why was Sodium Iodide (I-131) Solution, Therapeutic Oral recalled?

According to the FDA, the stated reason for the recall is: “Presence of Particulate Matter: Due to production issues.” In plain terms, this recall relates to a sterility or contamination concern.

Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.

What should you do?

If you think you may have bought Sodium Iodide (I-131) Solution, Therapeutic Oral, compare it against the product description and identifying codes (Batch I012626R-01, Exp 02/09/2026) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Radnostix or your local health authority.

About this recall

This recall was distributed in ID. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.

Full recall details

Status
Ongoing
Date reported
March 11, 2026
Recall started
January 26, 2026
Distributed in
ID
What was recalled
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
Why it was recalled (as stated by the FDA)
Presence of Particulate Matter: Due to production issues
How to identify the affected product
Batch I012626R-01, Exp 02/09/2026
Amount recalled
16 units

What you can do

Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.

Quick answers

Why was Sodium Iodide (I-131) Solution, Therapeutic Oral recalled?+

According to the FDA: Presence of Particulate Matter: Due to production issues

How serious is this recall?+

Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

What should I do if I have Sodium Iodide (I-131) Solution, Therapeutic Oral?+

Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.

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View the official FDA record

Opens the U.S. Food and Drug Administration (FDA) data for this recall.

Recall number: D-0389-2026. Information last synced from the FDA on July 6, 2026.

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