FDA recall, , Moderate risk
Radnostix Sodium Iodide I-131 Oral Solution
Sodium Iodide (I-131) Solution contains particulate matter due to production issues.
Summary by Recall Canary from the FDA notice
What happened
Radnostix, located in Idaho Falls, Idaho, recalled Sodium Iodide (I-131) Solution, Therapeutic Oral, due to the presence of particulate matter caused by production issues. The product is packaged as 1 ml, 2 ml, and 3 ml V-vials, with specific NDC and order listings. The recall, which began on January 26, 2026, was added to the FDA's Enforcement Report on March 5, 2026, and classified on March 13, 2026. The product was distributed nationwide in the USA and Puerto Rico, with 16 units affected.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
An NDC (National Drug Code) is usually printed on the drug's label.
Sodium Iodide (I-131) Solution, Therapeutic Oral
- NDC
- 69208-003-15
- 69208-003-25
- 69208-003-35
- Lot code
- I012626R-01
From the FDA notice
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.
Recall details
- Company began the recall
- Sold in
Nationwide in the USA and Puerto Rico
- Company
- RadnostixIdaho Falls, Idaho
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98470
- Recall number
- D-0389-2026
- Quantity recalled
- 16 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Listed on Recall Canary
Summary updated
