Recall Ledger

Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit recall (Radnostix)

DrugClass IIIOngoing

Summary: Radnostix is recalling 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. Reason: Failed Tablet/Capsule Specifications.

What is being recalled

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

Why

Failed Tablet/Capsule Specifications

How serious is it

Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.

Where it was sold

Nationwide in the US, including Puerto Rico (states named: Puerto Rico)

How to tell if yours is affected

Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0401-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass III
StatusOngoing
Recall startedFebruary 19, 2026
ReportedApril 1, 2026
CompanyRadnostix
Company locationIdaho Falls, ID, United States
Initiated byVoluntary: Firm initiated
Quantity2,699 blister cartons

More recalls from Radnostix · all drug recalls · recalls from February 2026

Official FDA record