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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
Related recalls
Same brand · SODIUM IODIDE I-131
- HighSodium iodide I-131 oral solution recalled over particulate matter
FDA (Drugs) · 2026-03-11
Same hazard · failed specification
See all →- HighMeclizine hydrochloride 12.5 mg tablets recalled after failing tablet specifications
FDA (Drugs) · 2026-04-01
- HighIcosapent ethyl capsules recalled after active ingredient oxidized inside capsule
FDA (Drugs) · 2026-03-18
- ModerateAmphetamine extended-release capsules 20 mg recalled over impurity and degradation results
FDA (Drugs) · 2025-10-01
- ModerateAmphetamine extended-release capsules 10 mg recalled over failed degradation specifications
FDA (Drugs) · 2025-10-01
- ModerateAmphetamine extended-release capsules 15 mg recalled after impurity testing failure
FDA (Drugs) · 2025-10-01
Similar recalls
- HighSodium iodide I-131 oral solution recalled over particulate matter
FDA (Drugs) · 2026-03-11
- LowJubilant DraxImage Recalls Sodium Iodide I 131 Diagnostic Due to Labeling Error
FDA (Drugs) · 2016-04-13
- SevereSodium Bicarbonate Tablets Recalled for Potential Label Mixup
FDA (Drugs) · 2014-01-22
- SevereInternational Laboratories Recalls Pravastatin Sodium Tablets Due to Foreign Tablets
FDA (Drugs) · 2018-01-31
- SevereFDA Recalls Mislabeled Docusate Sodium Capsules Distributed by Aidapak Services
FDA (Drugs) · 2014-01-22
- ModerateLevothyroxine Sodium Tablets Recalled for Potential Labeling Mixup
FDA (Drugs) · 2014-01-29