Recall of Sodium Iodide I-131 Due to Failed Specifications

Source: FDA · United States

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Radnostix is recalling 2,699 blister cartons of Gelatin Capsule Packs for Sodium Iodide I-131 kits because of failed tablet/capsule specifications, affecting nationwide distribution in the US.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 7, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Radnostix initiated a voluntary recall of the Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit due to failed tablet/capsule specifications. This Class III recall was announced following notification via letter.

Which Products Are Affected

The affected products are the Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit, containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, manufactured by International Isotopes Inc. The NDCs are 69208-003-15, 69208-003-25, and 69208-003-35. A total of 2,699 blister cartons are involved, with affected lots including Lot 3666245 expiring on 02/28/2026, Lot 4546213 expiring on 02/28/2026, and Lot 4951280 expiring on 09/30/2027. Distribution occurred nationwide in the US, including Puerto Rico.

What You Should Do

Consumers who have the affected products should follow the instructions in the letter from the recalling firm, Radnostix. For returns or refunds, contact Radnostix at their address: 4137 Commerce Cir, Idaho Falls, ID 83401-1205.

Why This Matters

This recall ensures the quality and safety of prescription drugs, affecting over 2,699 units distributed across the United States and potentially impacting patients relying on these products for treatment.

Source

This information is from the FDA recall announcement, recall number D-0401-2026. For more details, visit the FDA website.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Radnostix is recalling 2,699 blister cartons of Gelatin Capsule Packs for Sodium Iodide I-131 kits because of failed tablet/capsule specifications, affecting nationwide distribution in the US.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.