Medications & Supplements/Prescription Drugs

Radnostix Sodium Iodide (I-131) Solution Recalled for Particulate Matter

Agency Publication Date: March 5, 2026

Summary

Radnostix is recalling 16 units of Sodium Iodide (I-131) Solution, a therapeutic oral medication, because of the presence of particulate matter (unintended particles) caused by production issues. The recall affects three different vial sizes distributed nationwide and in Puerto Rico. Consumers are advised that this is a voluntary firm-initiated recall and should consult their healthcare provider regarding any concerns.

Risk

The presence of unintended particulate matter in an oral solution can pose a risk of irritation or injury to the digestive tract or other internal tissues if ingested.

What You Should Do

Check your medication packaging for Sodium Iodide (I-131) Solution with Batch I012626R-01 and an expiration date of 02/09/2026.
Identify your specific product using the vial size and order numbers: 1 ml V-vials (Orders 49317, 49323, 49325, 49329, 49333, 49339, 49341, 49355, 49364, 49380, 49392), 2 ml V-Vials (Orders 49353, 49457, 49477), or 3 ml V-vials (Orders 49454, 49406).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sodium Iodide (I-131) Solution, Therapeutic Oral

Variants: 1 ml V-vial, 2 ml V-vial, 3 ml V-vial

Model:

49317

49323

49325

49329

49333

49339

49341

49355

49364

49380

49392

49353

49457

49477

49454

49406

Lot Numbers:

I012626R-01 (Exp 02/09/2026)

NDC:

69208-003-15

69208-003-25

69208-003-35

Rx Only; Manufactured by International Isotopes Inc., Idaho Falls, ID.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98470

Status: Active

Manufacturer: Radnostix

Manufactured In: United States

Units Affected: 16 units

Distributed To: Nationwide

Agency Last Updated: March 13, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication packaging for Sodium Iodide (I-131) Solution with Batch I012626R-01 and an expiration date of 02/09/2026.

Identify your specific product using the vial size and order numbers: 1 ml V-vials (Orders 49317, 49323, 49325, 49329, 49333, 49339, 49341, 49355, 49364, 49380, 49392), 2 ml V-Vials (Orders 49353, 49457, 49477), or 3 ml V-vials (Orders 49454, 49406).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sodium Iodide (I-131) Solution, Therapeutic Oral

Variants: 1 ml V-vial, 2 ml V-vial, 3 ml V-vial

Model:

49317

49323

49325

49329

49333

49339

49341

49355

49364

49380

49392

49353

49457

49477

49454

49406

Lot Numbers:

I012626R-01 (Exp 02/09/2026)

NDC:

69208-003-15

69208-003-25

69208-003-35

Rx Only; Manufactured by International Isotopes Inc., Idaho Falls, ID.