CLASS III ONGOING Drug recall · Reported 1 Apr 2026 · FDA Enforcement Report
Gelatin Capsule Pack for use recalled by Radnostix
Radnostix is recalling Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing and 300 mg, distributed nationwide in the US. The recall was initiated on 19 Feb 2026 and the FDA has classified it as Class III.
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-0401-2026
- FDA event ID
- 98492
- Recalling firm
- Radnostix, Idaho Falls, ID
- Brand
- Sodium Iodide I-131
- Manufacturer
- Radnostix, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 19 Feb 2026
- FDA classified
- 20 Mar 2026
- Reported
- 1 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 19 Feb 2026 | Recall initiated by company | |
| 20 Mar 2026 | Classified by FDA | +29 days |
| 1 Apr 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35
Where it was distributed
Nationwide in the US, including Puerto Rico
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications
Which lots are affected?
Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
Where was it sold?
Nationwide in the US, including 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 II | Sodium Iodide (I-131) Solution, Therapeutic Oral recalled by RadnostixSodium Iodide I-131 | Radnostix | Particulate Matter | Nationwide |
Other Sodium Iodide I-131 recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Iodide (I-131) Solution, Therapeutic Oral recalled by RadnostixSodium Iodide I-131 | Radnostix | Particulate Matter | Nationwide |
| Drug | CLASS III | Sodium Iodide I, USP Diagnostic Oral recalled by Jubilant DraximageSodium Iodide I 131 Diagnostic | Jubilant Draximage | Other | Nationwide |