Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules… recall
FDA recall D-0401-2026 · initiated Feb 19, 2026
Radnostix recalled Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empt… in Feb 2026 — an FDA Class III recall (D-0401-2026) because Failed Tablet/Capsule Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Tablet/Capsule Specifications
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,699 blister cartons
Details
- 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
- Recalling company
- Radnostix
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US, including Puerto Rico
- Initiated
- Feb 19, 2026
- FDA report date
- Apr 1, 2026
Frequently asked
- Was Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empt… recalled?
- Radnostix recalled Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empt… in Feb 2026 — an FDA Class III recall (D-0401-2026) because Failed Tablet/Capsule Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empt… recalled?
- Per the FDA enforcement record, the reason for recall D-0401-2026 was: Failed Tablet/Capsule Specifications
- Is a recalled Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empt… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empt… are affected?
- Distributed: Nationwide in the US, including Puerto Rico. The recall covers these lots — Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0401-2026.