Radnostix Gelatin Capsules Recalled: Failed Tablet Specs

This alert was compiled from official government recall data published by the FDA using automated analysis. All facts are sourced directly from official records. Last verified April 8, 2026.

Here's the blog post: Heads up if you bought any Radnostix Gelatin Capsule Packs recently! There's a product recall in the United States that you need to know about. Specifically, this recall involves the Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit. Here's a quick rundown of the key info:

• Product: Gelatin Capsule Pack (for use with Sodium Iodide I-131 Kit)
• Brand: Radnostix
• Reason: Failed Tablet/Capsule Specifications
• Units Affected: 2,699 blister cartons
• Distribution: Nationwide across the U.S., including Puerto Rico
• Lots: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026; Lot 4951280, exp 09/30/2027

Nobody wants to find out their medical supplies are defective. Let's break down exactly what's happening, who's affected, and what you need to do to protect yourself and your family in 2026.

Radnostix Gelatin Capsule Pack Recall: What's Going On?

The Radnostix Gelatin Capsule Pack, used with the Sodium Iodide I-131 Kit, is being recalled due to "Failed Tablet/Capsule Specifications." That's the official reason given by the FDA. Based on the official recall notice, this means the capsules in the pack may not meet the required quality standards. This could affect the way the medication is absorbed or administered, potentially impacting your treatment. The recall affects a total of 2,699 blister cartons of the product. These capsules were sold across the U.S., including Puerto Rico. It's important for American shoppers to check if they have any of the affected lots. It's not clear exactly what the "failure" means, but the agency confirmed that it presents a potential risk, resulting in a Class III recall, which is initiated when a product violates FDA law but is unlikely to cause adverse health consequences. The specific product being recalled is the Gelatin Capsule Pack (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401). The NDC numbers are 69208-003-15, 69208-003-25, and 69208-003-35.

Is This a Serious Problem?

The FDA has classified this as a Class III recall. While that means the risk of serious health problems is considered low, it's still important to take this seriously. Any issue with medication integrity can potentially impact your health. If you are currently undergoing treatment with Sodium Iodide I-131 and are using these capsules, it's best to err on the side of caution. You should contact your doctor promptly and follow their advice.

Which Products Are Affected? Lot Numbers to Check

This is the most important part: check your product packaging *right now*. This recall is for specific lots of the Radnostix Gelatin Capsule Pack. Here are the affected lot numbers and expiration dates. If you have any of these, take action: * Lot 3666245, expiration date: 02/28/2026 * Lot 4546213, expiration date: 02/28/2026 * Lot 4951280, expiration date: 09/30/2027 These lot numbers should be printed on the product packaging. Take a moment to check the boxes in your home.

What To Do Right Now

If you have any of the recalled Radnostix Gelatin Capsule Packs, here's what you need to do:

1. Stop using the product immediately and set it aside so it won't be used accidentally.
2. Contact your healthcare provider to discuss alternative options for your treatment and any potential concerns.
3. Contact International Isotopes Inc. (the manufacturer) for instructions on how to return the product or for further information about the recall; their contact information should be on the product label or easily found online.

Where Were These Capsules Sold?

The FDA states that these capsules were distributed nationwide in the US, including Puerto Rico. It does not provide a list of specific retailers that sold the capsule packs. Because this is a medical product, it's likely that these were distributed through pharmacies and hospitals, not major U.S. retailers like Walmart, Target, Amazon, or Costco. This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.

Frequently Asked Questions

Q: What does "Failed Tablet/Capsule Specifications" mean?

The FDA did not specify what the failure actually *is*. It means the capsules don't meet the required quality standards, potentially affecting their effectiveness or safety. It could be a variety of issues regarding the integrity of the capsule itself.

Q: What is a Class III recall?

A Class III recall is issued when a product violates FDA regulations but isn't likely to cause serious health problems or death. It indicates a lower level of risk compared to Class I and Class II recalls.

Q: Do I need to see a doctor?

You should contact your healthcare provider if you've used the recalled capsules, especially if you have any concerns about your treatment or have experienced any unusual symptoms. It is always best to consult a medical professional.

Q: How do I return the recalled product?

Contact International Isotopes Inc. (the manufacturer) directly for instructions on how to return the product. They will provide you with the necessary information and steps to follow.

Q: Where can I find more information about this recall?

The official source of information is the U.S. Food and Drug Administration (FDA). You can find the complete details and the official notice on their website at www.fda.gov.