Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit — Class III drug recall D-0401-2026
Ongoing recall by Radnostix, reported 2026-04-01, distributed nationwide. Failed Tablet/Capsule Specifications
| Recall number | D-0401-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radnostix, Idaho Falls, ID, United States |
| Recall initiated | 2026-02-19 |
| Classified | 2026-03-20 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 2,699 blister |
| NDC | 69208-0000, 69208-0000-00, 69208-0003-15, 69208-0003-25, 69208-0003-35 |
| Lot numbers | 3666245, 4546213, 4951280 |
| Expiration dates | 2026-02-28, 2027-09-30 |
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
Reason for recall
Failed Tablet/Capsule Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0401-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.