Recalls / Class III
Class IIID-0401-2026
Product
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
- Brand name
- Sodium Iodide I-131
- Generic name
- Sodium Iodide I-131
- Route
- Oral
- NDC
- 69208-000
- FDA application
- ANDA209166
- Affected lot / code info
- Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
Why it was recalled
Failed Tablet/Capsule Specifications
Recalling firm
- Firm
- Radnostix
- Manufacturer
- Radnostix, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4137 Commerce Cir, Idaho Falls, Idaho 83401-1205
Distribution
- Quantity
- 2,699 blister cartons
- Distribution pattern
- Nationwide in the US, including Puerto Rico
Timeline
- Recall initiated
- 2026-02-19
- FDA classified
- 2026-03-20
- Posted by FDA
- 2026-04-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0401-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.