Sodium Iodide — Class II drug recall D-0389-2026
Ongoing recall by Radnostix, reported 2026-03-11, distributed nationwide. Presence of Particulate Matter: Due to production issues
| Recall number | D-0389-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radnostix, Idaho Falls, ID, United States |
| Recall initiated | 2026-01-26 |
| Classified | 2026-03-13 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 16 units |
| Reason classes | specification failure |
| NDC | 69208-0000, 69208-0000-00, 69208-0003-15, 69208-0003-25, 69208-0003-35 |
| Lot numbers | I012626R-01 |
| Expiration dates | 2026-02-09 |
Product
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
Reason for recall
Presence of Particulate Matter: Due to production issues
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-0389-2026. 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.