Radnostix

FDA Regulatory Profile

Radnostix appears in FDA public data with 2 recalls, 0 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0401-2026, Class III) was initiated on February 19, 2026.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0401-2026Class IIIGelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 DibFebruary 19, 2026
D-0389-2026Class IISodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; OrdeJanuary 26, 2026