The Recall Desk
HighFDA (Drugs)·D-0389-2026·Announced 2026-03-11

Sodium iodide I-131 oral solution recalled over particulate matter

Radnostix is recalling one batch of Sodium Iodide I-131 Therapeutic Oral Solution because of the presence of particulate matter caused by production issues.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a therapeutic solution found to contain particulate matter, with no injuries stated in the source.

Plain-English summary

Radnostix is recalling Sodium Iodide (I-131) Solution, Therapeutic Oral, prescription only, manufactured by International Isotopes Inc. of Idaho Falls, Idaho. The recall covers 1 ml V-vials (NDC 69208-003-15), 2 ml V-vials (NDC 69208-003-25) and 3 ml V-vials (NDC 69208-003-35). About 16 units were distributed nationwide in the United States and Puerto Rico. The FDA has classified this recall as Class II.

The recall was initiated for presence of particulate matter due to production issues.

Affected product is batch I012626R-01 with an expiry date of 02/09/2026, covering orders 49317, 49323, 49325, 49329, 49333, 49339, 49341, 49355, 49364, 49380 and 49392 for the 1 ml vials, orders 49353, 49457 and 49477 for the 2 ml vials, and orders 49454 and 49406 for the 3 ml vials.

Clinicians and pharmacies can identify affected product by the NDC, batch and order numbers above, and may contact Radnostix for further information.

The recalled product

Product
SODIUM IODIDE I-131 (SODIUM IODIDE I-131)
Brand
SODIUM IODIDE I-131
Manufacturer
Radnostix
Category
Drug — Radiopharmaceutical
Hazard
Affected units
16

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Batch I012626R-01
  • Exp 02/09/2026

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same brand · SODIUM IODIDE I-131

Same hazard · particulate matter

See all →