FDA recall D-0401-2026

Radnostix · Class III · drug

Product

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

Reason for recall

Failed Tablet/Capsule Specifications

Distribution

Nationwide in the US, including Puerto Rico

Key facts

Status: Ongoing
Initiation date: 2026-02-19
Report date: 2026-04-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Idaho Falls, ID, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0401-2026