Immunocore recalls KIMMTRAK (tebentafusp-tebn) injection due to subpotent drug risk. Affected lots expire March 2026. No specific remedy stated in recall notice.
Subpotent Drug
Immunocore is recalling KIMMTRAK (tebentafusp-tebn) injections that may be subpotent. This means the medication might not work as intended, potentially reducing treatment effectiveness. The recall affects specific lots of the product that expire in March 2026.
The product is labeled as 'subpotent,' meaning it may not contain the full amount of active ingredient needed for treatment. This could lead to reduced effectiveness of the medication. However, the recall does not indicate immediate safety risks like injury or death.
Patients receiving KIMMTRAK injections for certain cancers are affected. Those with the specific product lots listed in the recall are most at risk.
Check for the product name KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL. Look for specific lot numbers: 3D009AA02, 3D009AA09, 3D009AA10, or 3D009AA25. The expiration date is March 31, 2026.
Identify the lot number and expiration date on the KIMMTRAK injection vial to determine if it is affected.
The recall states the product may be subpotent, but no specific safety risks are mentioned. The product is not considered immediately dangerous.
The recall does not specify a remedy, so no action is required beyond checking the product details.
Check the lot number on the vial; affected lots are 3D009AA02, 3D009AA09, 3D009AA10, or 3D009AA25 with an expiration date of March 31, 2026.
We’ve drafted a message you can send Immunocore to request your refund or repair — edit it as you like.
Subject: Recall D-0614-2025 — Immunocore Immunocore Hello, I own a Immunocore that is covered by recall D-0614-2025 from Immunocore. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
