FDA Drugs recall ·
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing… recall
Read the official FDA notice ↗
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
Why was it recalled?
Failed Tablet/Capsule Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
Distribution
Nationwide in the US, including Puerto Rico
States: Puerto Rico
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0401-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.