February 2026 FDA Recall Sodium Iodide I-131 by Radnostix
D-0401-2026 - Failed Tablet/Capsule Specifications
This Class III drug recall was voluntarily initiated by Radnostix on February 19, 2026 for the product Sodium Iodide I-131. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0401-2026
Failed Tablet/Capsule Specifications
02-19-2026
04-01-2026
2,699 blister cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Radnostix
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US, including Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
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
