SODIUM IODIDE I-131
Recalling Firm / Manufacturer: Radnostix
(Idaho Falls, ID, United States)
FDA Recall Number: D-0401-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
SODIUM IODIDE I-131
Generic Name
SODIUM IODIDE I-131
Active Substance(s)
Not provided by source
Administration Route
Oral
National Drug Code (NDC)
69208-000
Total Quantity Recalled
2,699 blister cartons
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Tablet/Capsule Specifications
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
April 01, 2026
Firm Initiation Date
February 19, 2026
FDA Classification Date
Mar 20, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
Distribution Information
Geographic scope of affected shipments
Nationwide in the US, including Puerto Rico
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Related Questo Medical Knowledge
Clinical cases and condition overviews related to this medication
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0401-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508604UTCC