Sodium Iodide Solution Recall: Radnostix Gel Capsule Pack
Announced 2026-04-01 · FDA
FDA is recalling Radnostix Sodium Iodide (I-131) Solution due to presence of particulate matter from production issues. The batch I012626R-01 (Exp 02/09/2026) consists of 16 units distributed nationwide in the USA and Puerto Rico. The product is Rx Only and manufactured by International Isotopes Inc.
| Brand | Radnostix |
|---|---|
| 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 |
| Severity | moderate |
| Units affected | 2699 |
| Distribution | Nationwide in the USA and Puerto Rico |
| Agency | FDA |
| Recall / campaign no. | Batch I012626R-01, Exp 02/09/2026 |
WHAT YOU SHOULD DO
- Do not use the affected Radnostix Sodium Iodide (I-131) Solution.
- If you have units from batch I012626R-01, stop using them and contact the distributor or your healthcare provider for instructions.
- Return or dispose of the recalled product according to local regulations or as directed by the distributor or FDA recall guidance.
- If you experienced any adverse effects, report them to the FDA MedWatch program.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.