Quick Facts at a Glance
- Recall Date
- June 10, 2025
- Hazard Level
- HIGH
- Brand
- IMMUNOCORE
- 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
- IMMUNOCORE
- Product type
- Injection
- Model numbers
- NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, NDC 80446-0401-99 Lot #: 3D009AA02
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 10, 2025
Reported by FDA DRUG
September 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Subpotent Drug
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact IMMUNOCORE, LLC or your healthcare provider for guidance. Notification method: N/A
About This Product
KIMMTRAK (tebentafusp-tebn) Injection is used for treating specific cancers. Patients buy this product as part of their treatment regimen for serious health conditions, particularly melanoma.
Why This Is Dangerous
The drug's subpotency means it may not contain the necessary potency to effectively treat patients, potentially compromising their health and treatment outcomes.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on KIMMTRAK for cancer treatment may face disruption in their regimen, leading to possible treatment delays or ineffectiveness.
Practical Guidance
How to identify if yours is affected
- Check the lot number on the KIMMTRAK vial.
- Ensure it matches one of the recalled lots: 3D009AA09, 3D009AA10, 3D009AA25, 3D009AA02.
- Examine the expiration date, which should be March 31, 2026.
Where to find product info
Lot numbers and expiration dates are typically printed on the product packaging or the vial label itself.
What timeline to expect
Expect resolution for refunds or replacements within 4-6 weeks after contacting the manufacturer or your healthcare provider.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer.
- Seek follow-up communications if replies are delayed.
- Contact the FDA or a consumer protection agency for additional support.
How to prevent similar issues
- Always check for recalls before starting new medications.
- Consult with your healthcare provider about any changes or recalls in your medications.
Documentation advice
Keep records of your KIMMTRAK injections, including lot numbers, expiration dates, and any correspondence regarding the recall.
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Product Details
- Product: KIMMTRAK (tebentafusp-tebn) Injection 100 mcg/0.5 mL - Manufactured by: Immunocore Limited - Product of: Denmark - Lot Numbers: 3D009AA09, 3D009AA10, 3D009AA25, 3D009AA02 - Expiration Date: March 31, 2026 - NDC Numbers: 80446-0401-01, 80446-0401-99 - Quantity: 7,572 vials
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product expiration date: March 31, 2026
- Stop using the product immediately.
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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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