Quick Facts at a Glance
- Recall Date
- January 26, 2026
- Hazard Level
- HIGH
- Brands
- SODIUM IODIDE I-131, Radnostix
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SODIUM IODIDE I-131, Radnostix
- Product type
- Sodium Iodide I-131 Solution, Therapeutic Oral
- Model numbers
- Batch I012626R-01, Exp 02/09/2026
- UPC codes
- 69208-000, 69208-000-00, 69208-003-15, 69208-003-25, 69208-003-35
- Sizes
- 1 ml, 2 ml, 3 ml
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 26, 2026
Reported by FDA DRUG
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Presence of Particulate Matter: Due to production issues
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Radnostix or your healthcare provider for guidance. Notification method: Letter
About This Product
Sodium Iodide I-131 Solution is a radiopharmaceutical used in therapy for certain thyroid conditions. The product is supplied in 1 ml, 2 ml, and 3 ml V-Vials with corresponding NDCs.
Why This Is Dangerous
Particulate matter in the solution can compromise safety and efficacy. Contamination could affect dosage accuracy and patient safety.
Industry Context
This recall is not reported as part of a broader industry pattern.
Real-World Impact
Health care providers may need to pause treatments and seek alternative therapies. Patients could face delays in therapy while replacements are sourced.
Practical Guidance
How to identify if yours is affected
- Check batch: I012626R-01
- Check expiration: Exp 02/09/2026
Where to find product info
Label on vial or packaging shows NDC, batch, and expiration date
What timeline to expect
Recall notices typically include next steps; refunds or replacements may take weeks (4-8 weeks commonly)
If the manufacturer is unresponsive
- File a report with FDA MedWatch if the company is unresponsive
- Consult your healthcare provider for interim guidance
- Keep records of all communications
How to prevent similar issues
- Verify NDCs and batch numbers before receiving radiopharmaceuticals
- Purchase only from authorized pharmacies or licensed medical suppliers
- Ensure proper storage and handling per physician directions
Documentation advice
Keep recall notice, prescriptions, batch numbers, receipts, and all correspondence
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Product Details
- Model numbers: Batch I012626R-01; Exp 02/09/2026 - NDC codes: 69208-003-15 (1 ml), 69208-003-25 (2 ml), 69208-003-35 (3 ml) - Sold as Rx Only - Manufactured by: International Isotopes Inc., Idaho Falls, ID - Quantity recalled: 16 units - Distribution: Nationwide in the USA and Puerto Rico - Price: Not disclosed
Key Facts
- 16 total recalled units
- Batch I012626R-01
- Manufactured in the United States by International Isotopes Inc.
- Nationwide distribution in the USA and Puerto Rico
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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