Quick Facts at a Glance
- Recall Date
- February 19, 2026
- Hazard Level
- HIGH
- Brands
- SODIUM IODIDE I-131, Radnostix, Inc.
- 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, Inc.
- Product type
- Gelatin Capsule Pack for Radiopharmaceutical Kit
- Model numbers
- Lot, expiry: Lot 3666245, exp: 02/28/2026, Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
- UPC codes
- 69208-000, 69208-000-00, 69208-003-15, 69208-003-25, 69208-003-35
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 19, 2026
Reported by FDA DRUG
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Tablet/Capsule Specifications
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
Gelatin capsule packs are components used with radiopharmaceutical kits, specifically the Sodium Iodide I-131 kit. They include capsules intended for medical procedures.
Why This Is Dangerous
The failed tablet/capsule specifications may affect dosage accuracy or capsule integrity, potentially impacting treatment effectiveness or safety.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided information.
Real-World Impact
No reported injuries to date. The recall requires immediate cessation of use to mitigate potential risks.
Practical Guidance
How to identify if yours is affected
- Check lot numbers 3666245, 4546213, 4951280 on blister cartons.
- Note expiry dates: 02/28/2026 for the first two lots; 09/30/2027 for Lot 4951280.
Where to find product info
Recall notices and lot/NDC details are on the FDA enforcement page linked in the recall notice. Manufacturer letters will provide next steps.
What timeline to expect
Refunds or replacements are typically processed within 4-8 weeks after the recall resolution is confirmed by the company.
If the manufacturer is unresponsive
- Escalate to the FDA recall contact page if the company is slow to respond.
- Consider reporting to the CPSC or FDA if you suspect a safety issue is not being addressed.
How to prevent similar issues
- Always verify NDC and lot numbers before use.
- Maintain awareness of recall statuses for radiopharmaceutical components.
- When purchasing radiopharmacy kits, request official documentation and recall checks from the supplier.
Documentation advice
Retain recall letter, purchase receipts, lot/NDC numbers, and any correspondence with Radnostix or healthcare providers.
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Product Details
Product: Gelatin Capsule Pack for Sodium I-131 Kit. Contains 5 empty capsules and 5 Dibasic Sodium Phosphate capsules (300 mg). NDCs: 69208-003-15; 69208-003-25; 69208-003-35. Quantity: 2,699 blister cartons. Distributed nationwide in the US, including Puerto Rico. Sold by: Radnostix, Inc. Model numbers: Lot 3666245; Lot 4546213; Lot 4951280. Expirations: 02/28/2026 for first two lots, 09/30/2027 for Lot 4951280.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 2,699 blister cartons recalled
- Distributed nationwide in US including Puerto Rico
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Safety Guide
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