FDAFDA · Food and drugs·Recall number D-0389-2026
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.
Published March 11, 2026 · Recall initiated: January 26, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Due to production issues
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SODIUM IODIDE I-131
- Manufacturer
- Radnostix
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Batch I012626R-01, Exp 02/09/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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