United StatesSodium Iodide (I-131) Solution, Therapeutic Oral packaged as 1 ml V‑vial (NDC 69208‑003‑15; Orders 49317, 49323, 49325, 49329, 49333, 49339, 49341, 49355, 49364, 49380, 49392), 2 ml V‑vial (NDC 69208‑003‑25; Orders 49353, 49457, 49477) and 3 ml V‑vial (NDC 69208‑003‑35; Orders 49454, 49406), batch I012626R‑01, Exp 02/09/2026, manufactured by International Isotopes Inc. is affected. Radnostix is recalling these units nationwide (including Puerto Rico) due to the presence of particulate matter from production issues.
What's being recalled
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.
Recalling firm: Radnostix, Idaho Falls, ID, United States.
How to identify it
Batch I012626R-01, Exp 02/09/2026
The hazard
Presence of Particulate Matter: Due to production issues
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA and Puerto Rico
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)