FDA Drug recall D-0389-2026
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15
- FDA Drug
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15 by Radnostix, citing presence of Particulate Matter: Due to production issues.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0389-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-26 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Radnostix |
| Distribution | US |
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
Presence of Particulate Matter: Due to production issues
Identifiers
| ndc | 69208-000-00 |
|---|---|
| ndc | 69208-003-15 |
| ndc | 69208-003-25 |
| ndc | 69208-003-35 |
| code_info | Batch I012626R-01, Exp 02/09/2026 |
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-0389-2026%22
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