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Class III: unlikely to cause harmOngoing

Radnostix Gelatin Capsule Pack for use with the Sodium Recall

Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsu…

Radnostix · Idaho Falls, ID

Risk level
Class III
Reported by FDA
Apr 1, 2026
Recall ID
D-0401-2026
Check your lot numberHow we source this data

Summary

Radnostix recalled Gelatin Capsule Pack for use with the Sodium starting Feb 19, 2026. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0401-2026 on Apr 1, 2026. Reason: Failed Tablet/Capsule Specifications. Status: Ongoing.

Why it was recalled

Failed Tablet/Capsule Specifications

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 numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the US, including Puerto Rico

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0401-2026
Classification
Class III
Status
Ongoing
Recall initiated
Feb 19, 2026
FDA report date
Apr 1, 2026
Quantity
2,699 blister cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Radnostix

Original FDA data

Every field from FDA enforcement report D-0401-2026, exactly as published.

Show all FDA fields
City
Idaho Falls
State
ID
Status
Ongoing
Country
United States
Event ID
98492
Address
4137 Commerce Cir
Code information
Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
Postal code
83401-1205
Report date
Apr 1, 2026
Product type
Drugs
Recall number
D-0401-2026
Classification
Class III
Recalling firm
Radnostix
Product quantity
2,699 blister cartons
Reason for recall
Failed Tablet/Capsule Specifications
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide in the US, including Puerto Rico
Recall initiation date
Feb 19, 2026
Initial firm notification
Letter
Center classification date
Mar 20, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0401-2026, published Apr 1, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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