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Class II · ModerateActive recall

Sodium Iodide I-131

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch I012626R-01, Exp 02/09/2026
Where it was soldNationwide in the USA and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Particulate Matter: Due to production issues

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byInternational Isotopes Inc., Idaho Falls, ID
Brand nameSODIUM IODIDE I-131
Generic nameSODIUM IODIDE I-131
Distributed by / forRadnostix
NDC69208-003-15
Show the full FDA record
Full product labelSodium 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.
Recalling firmRadnostix
DistributionNationwide in the USA and Puerto Rico
Quantity16 units
Recall initiated2026-01-26
Report date2026-03-11
Recall completed
Recall numberD-0389-2026
ClassificationClass II
FDA statusOngoing
Origin on fileIdaho Falls ID United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.