Sodium Iodide I-131 Kit
FDA Recall NDC 69208-000
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sodium Iodide I-131 (NDC 69208-000). A significant event, classified as Class III, was initiated on Feb 19, 2026 by Radnostix, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Tablet/Capsule Specifications
Feb 19, 2026
Apr 01, 2026
2,699 blister cartons
Recall Profile & Regulatory Data
Event ID
98492
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Radnostix
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US, including Puerto Rico
Product Description
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
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
Affected Packages Involved in this Recall
69208-000-00Product
69208-003-15Product
69208-003-25Product
69208-003-35Product
Class II Ongoing
Presence of Particulate Matter: Due to production issues
Jan 26, 2026
Mar 11, 2026
16 units
Recall Profile & Regulatory Data
Event ID
98470
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Radnostix
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Product Description
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
Batch or Lot Expiration Information
Batch# Batch I012626R-01, Exp 02/09/2026
Affected Packages Involved in this Recall
69208-000-00Product
69208-003-15Product
69208-003-25Product
69208-003-35Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
