IMMUNOCORE, LLC

IMMUNOCORE's KIMMTRAK (Tebentafusp-tebn) Subpotency Triggers Class II US Nationwide Recall

IMMUNOCORE, LLC has initiated a Class II recall for 7,572 vials of KIMMTRAK (tebentafusp-tebn) Injection due to subpotency, impacting US nationwide distribution. This voluntary action, initiated June 10, 2025, highlights critical quality control challenges in a complex global supply chain spanning Denmark, the UK, and the US. Procurement and regulatory teams must assess immediate supply risks and ensure robust quality oversight for specialized oncology therapeutics.