Radnostix Recalls Sodium Iodide I-131 Therapeutic Oral Solution Due to Particulate Matter
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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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, pharmaceuticals.
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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