Sodium iodide capsule packs recalled after failing capsule specifications
Radnostix is recalling three lots of the Gelatin Capsule Pack used with the Sodium Iodide I-131 Kit because the product failed tablet and capsule specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The rubric places FDA Class III recalls at 1 or 2, and the source names a failed capsule specification without describing any hazard, illness or injury.
Plain-English summary
Radnostix is recalling the Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit, containing five empty capsules and five Dibasic Sodium Phosphate Capsules 300 mg, made by International Isotopes Inc. of Idaho Falls, Idaho, NDC 69208-003-15, 69208-003-25 and 69208-003-35. About 2,699 blister cartons were distributed nationwide in the United States including Puerto Rico. The FDA has classified this recall as Class III.
The recall was initiated for failed tablet/capsule specifications. The source record does not name which specification the product failed.
Affected product covers lot 3666245 (expiry 02/28/2026), lot 4546213 (expiry 02/28/2026) and lot 4951280 (expiry 09/30/2027).
Clinicians and pharmacies can identify affected product by the NDC and lot numbers above, and may contact Radnostix for further information.
The recalled product
- Product
- SODIUM IODIDE I-131 (SODIUM IODIDE I-131)
- Brand
- SODIUM IODIDE I-131
- Manufacturer
- Radnostix
- Affected units
- 2,699
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot
- expiry: Lot 3666245
- exp: 02/28/2026
- Lot 4546213
- exp: 02/28/2026 and Lot 4951280
- exp 09/30/2027
Distribution
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