FDA-Drug2026-03-11Class IIPROCESSING DEFECT
Radnostix Sodium Iodide I-131 solution recalled for particulate matter
OTHERNationwide distribution
Do not use Radnostix Sodium Iodide I-131 solution
Radnostix Sodium Iodide (I-131) Solution, a prescription oral therapeutic medication, is being recalled because some vials contain particulate matter due to production issues. The affected medication is in 1 ml, 2 ml, and 3 ml vials with batch number I012626R-01 and expiration date 02/09/2026. No injuries have been reported.
- Do not administer this medication to patients.
- Check your inventory for batch I012626R-01 with expiration 02/09/2026.
- Contact your supplier or the manufacturer (International Isotopes Inc.) for return or disposal instructions.
- Notify patients who may have received doses from affected vials.
Hazard
Presence of Particulate Matter: Due to production issues
Sold states
Nationwide in the USA and Puerto Rico
Affected count
16 units
Manufactured in
4137 Commerce Cir, N/A, Idaho Falls, ID, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2026More Radnostix recalls
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief