FDA recall record

SODIUM IODIDE I-131 Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit recall — FDA D-0401-2026

Failed Tablet/Capsule Specifications

Class IIIclassification
D-0401-2026official record ID
Apr 1, 2026report date

Recall record at a glance

Official recordD-0401-2026
CategoryDrug Recalls
ClassificationClass III
FDA record statusOngoing
Recalling firmRadnostix
Report dateApr 1, 2026
Recall initiation dateFeb 19, 2026
Quantity2,699 blister cartons
LocationIdaho Falls, ID, United States

Official product description

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

Why the product was recalled

Failed Tablet/Capsule Specifications

Distribution information

Nationwide in the US, including Puerto Rico

How to read the classification

FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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