Recall of Sodium Iodide I-131 Due to Failed Specifications
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
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 ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,411 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to April 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.