FDA-Drug2026-04-01Class IIIPROCESSING DEFECT
Radnostix Gelatin Capsule Pack recalled for failed capsule specifications
What this means
Radnostix Gelatin Capsule Packs used with Sodium Iodide I-131 Kit have failed quality specifications. The affected capsules may not perform as intended. Three specific lots distributed nationwide are involved.
- Check if you have Radnostix Gelatin Capsule Pack Lot 3666245, 4546213, or 4951280
- Stop using affected capsules immediately
- Contact your healthcare provider or pharmacy for instructions on next steps
The agency's original wording
Hazard
Failed Tablet/Capsule Specifications
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the US, including Puerto Rico
Affected count
2,699 blister cartons
Manufactured in
4137 Commerce Cir, Idaho Falls, ID, United States
Products
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0401-2026Want us to check the next one for you?
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