FDA recall, , Low risk
International Isotopes Gelatin Capsule Pack for Sodium Iodide I-131 Kit
The Gelatin Capsule Pack failed tablet or capsule specifications.
Summary by Recall Canary from the FDA notice
What happened
Radnostix, of Idaho Falls, Idaho, recalled the Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit, containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, because it failed tablet or capsule specifications. The recall began on February 19, 2026, and was added to the FDA's Enforcement Report on March 20, 2026. The product was distributed nationwide in the US, including Puerto Rico.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your kit affected?
Affected if its NDC and lot code are listed under that product.
An NDC (National Drug Code) is usually printed on the drug's label.
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit
- NDC
- 69208-003-15
- 69208-003-25
- 69208-003-35
- Lot code
- 3666245
- 4546213
- 4951280
Recall details
- Company began the recall
- Sold in
Nationwide in the US, including Puerto Rico
- Company
- RadnostixIdaho Falls, Idaho
- Hazard
- Quality testing problem
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98492
- Recall number
- D-0401-2026
- Quantity recalled
- 2,699 blister cartons
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
