Radnostix Recalls Sodium Iodide I-131 Therapeutic Oral Solution Due to Particulate Matter

Source: FDA · United States and Puerto Rico

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Radnostix has issued a voluntary recall for 16 units of Sodium Iodide (I-131) Therapeutic Oral Solution after the discovery of particulate matter caused by production issues.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 2, 2026 and geographically references United States and Puerto Rico. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

Radnostix has initiated a voluntary recall of specific units of Sodium Iodide (I-131) Therapeutic Oral Solution. The recall was prompted by the presence of particulate matter in the solution, which was attributed to production issues. The FDA has classified this as a Class II recall.

Which Products Are Affected

The recall affects 16 units of Sodium Iodide (I-131) Solution, Therapeutic Oral, manufactured by International Isotopes Inc. and distributed by Radnostix. The affected products include Batch I012626R-01 with an expiration date of 02/09/2026. Specific packaging and order numbers include:

  • 1 ml V-vial (NDC 69208-003-15): Order numbers 49317, 49323, 49325, 49329, 49333, 49339, 49341, 49355, 49364, 49380, 49392.
  • 2 ml V-vial (NDC 69208-003-25): Order numbers 49353, 49457, 49477.
  • 3 ml V-vial (NDC 69208-003-35): Order numbers 49454, 49406.

These products were distributed nationwide across the United States and Puerto Rico.

What You Should Do

Radnostix notified affected customers via letter starting on January 26, 2026. Healthcare providers and facilities in possession of the affected batch should immediately stop use and follow the instructions provided in the notification letter for the return or disposal of the product. For further inquiries, the recalling firm is located at 4137 Commerce Cir, Idaho Falls, ID 83401.

Why This Matters

The presence of unintended particulate matter in a prescription drug can pose health risks to patients. A Class II recall indicates that the use of the product may cause temporary or medically reversible adverse health consequences.

Source

Information provided by the FDA under recall number D-0389-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Radnostix has issued a voluntary recall for 16 units of Sodium Iodide (I-131) Therapeutic Oral Solution after the discovery of particulate matter caused by production issues.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States and Puerto Rico. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.