CLASS II ONGOING Drug recall · Reported 11 Mar 2026 · FDA Enforcement Report
Sodium Iodide (I-131) Solution, Therapeutic Oral recalled by Radnostix
Radnostix is recalling Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) V-vial, distributed nationwide in the US. The recall was initiated on 26 Jan 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0389-2026
- FDA event ID
- 98470
- Recalling firm
- Radnostix, Idaho Falls, ID
- Brand
- Sodium Iodide I-131
- Manufacturer
- Radnostix, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jan 2026
- FDA classified
- 13 Mar 2026
- Reported
- 11 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Jan 2026 | Recall initiated by company | |
| 11 Mar 2026 | Published in enforcement report | +44 days |
| 13 Mar 2026 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Due to production issues
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Due to production issues
Which lots are affected?
Batch I012626R-01, Exp 02/09/2026
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Radnostix
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Gelatin Capsule Pack for use recalled by RadnostixSodium Iodide I-131 | Radnostix | Packaging Defects | Nationwide |
Other Sodium Iodide I-131 recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Gelatin Capsule Pack for use recalled by RadnostixSodium Iodide I-131 | Radnostix | Packaging Defects | Nationwide |
| Drug | CLASS III | Sodium Iodide I, USP Diagnostic Oral recalled by Jubilant DraximageSodium Iodide I 131 Diagnostic | Jubilant Draximage | Other | Nationwide |