Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphat
Summary
The FDA issued a Class III for Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empt by Radnostix. Reason: Failed Tablet/Capsule Specifications.
Details
Source
Drug Recall
External ID
D-0401-2026
Action Date
2026-04-01
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
Quantity Affected: 2,699 blister cartons
Reason for Recall
Failed Tablet/Capsule Specifications
Distribution
Nationwide in the US, including Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-19
Company
Idaho Falls, ID
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Radnostix has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Radnostix) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Radnostix have FDA actions?
Radnostix has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0401-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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