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 |
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.
How to identify the recalled item
| Lot / date codes | Batch I012626R-01, Exp 02/09/2026 |
|---|---|
| Lot / date codes | Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.