Class II · Moderate risk
Sodium Iodide
Presence of Particulate Matter: Due to production issues
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Tablet/Capsule Specifications
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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
Affected NDCs
69208-0003-15
69208-0003-25
69208-0003-35
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Radnostix
- Origin
- ID, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0401-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other recalls by Radnostix
All 2026 recallsOther failed specification recalls from 2026
All failed specification recalls
Class II · Moderate risk
Pemrydi Rtu
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Class II · Moderate risk
Pemrydi Rtu
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Class II · Moderate risk
Dicyclomine Hydrochloride Capsules
shortfill; reports of empty capsules.
Class II · Moderate risk
Rising
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
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