Sodium Iodide (I-131) Solution recall
FDA recall D-0389-2026 · initiated Jan 26, 2026
Radnostix recalled Sodium Iodide (I-131) Solution in Jan 2026 — an FDA Class II recall (D-0389-2026) because Presence of Particulate Matter: Due to production issues.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter: Due to production issues
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 16 units
Details
- 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.
- Recalling company
- Radnostix
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Jan 26, 2026
- FDA report date
- Mar 11, 2026
Frequently asked
- Was Sodium Iodide (I-131) Solution recalled?
- Radnostix recalled Sodium Iodide (I-131) Solution in Jan 2026 — an FDA Class II recall (D-0389-2026) because Presence of Particulate Matter: Due to production issues. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Sodium Iodide (I-131) Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0389-2026 was: Presence of Particulate Matter: Due to production issues
- Is a recalled Sodium Iodide (I-131) Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sodium Iodide (I-131) Solution are affected?
- Distributed: Nationwide in the USA and Puerto Rico. The recall covers these lots — Batch I012626R-01, Exp 02/09/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0389-2026.