Radnostix recalls Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 493…

Recall date

January 26, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0389-2026

FDA classification

Class II

Brand / firm

Radnostix

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Presence of Particulate Matter: Due to production issues

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was 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.