Radnostix Class II Drug Recall for Sodium Iodide

FDA: Drug Recalls Class II

Filed March 11th, 2026

Detected March 28th, 2026

Summary

The FDA has initiated a Class II drug recall for Radnostix's Sodium Iodide (I-131) Solution, identified as D-0389-2026. The recall is due to the presence of particulate matter resulting from production issues and affects distribution nationwide in the USA and Puerto Rico.

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What changed

The FDA has classified a Class II recall (D-0389-2026) for Radnostix's Sodium Iodide (I-131) Solution, therapeutic oral, due to the presence of particulate matter stemming from production issues. This recall impacts multiple lot numbers packaged in 1 ml and 2 ml vials, distributed nationwide in the USA and Puerto Rico.

Companies involved in the distribution or handling of this product must immediately cease distribution and implement recall procedures. Compliance officers should verify the affected product is removed from inventory and returned according to the manufacturer's instructions. Failure to comply with recall procedures can result in regulatory action and potential penalties.

What to do next

Cease distribution of affected Sodium Iodide (I-131) Solution
Remove recalled product from inventory
Follow manufacturer's instructions for product return

Source document (simplified)

Radnostix

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0389-2026 · 20260311 · Ongoing

Product

Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, N...