FDA Drug recall D-0401-2026
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg,…
- FDA Drug
- Class III
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class III recall of Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg,… by Radnostix, citing failed Tablet/Capsule Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0401-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-02-19 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Radnostix |
| Distribution | US |
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
Failed Tablet/Capsule Specifications
Identifiers
| ndc | 69208-000-00 |
|---|---|
| ndc | 69208-003-15 |
| ndc | 69208-003-25 |
| ndc | 69208-003-35 |
| code_info | Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0401-2026%22
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