Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; O...
FDA Recall #D-0389-2026 — Class II — January 26, 2026
Product Description
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 for Recall
Presence of Particulate Matter: Due to production issues
Recalling Firm
Radnostix — Idaho Falls, ID
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
16 units
Distribution
Nationwide in the USA and Puerto Rico
Code Information
Batch I012626R-01, Exp 02/09/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated