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CLASS II · ModerateFDA

Radnostix recalls Sodium Iodide

📅 Jan 26, 2026 · 📍 Nationwide
Recalling company
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
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jan 26, 2026
Reported
Mar 11, 2026
Distribution
Nationwide in the USA and Puerto Rico
Status
Ongoing
Quantity
16 units
Lot / codes
Batch I012626R-01, Exp 02/09/2026
Company location
Idaho Falls, ID
Recall type
Voluntary: Firm initiated
Recall number
D-0389-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0389-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.