KIMMTRAK (tebentafusp-tebn) Injection Recalled Due to Subpotency

The US Food and Drug Administration (FDA) has issued a Class II recall for KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, a prescription biologic used for intravenous infusion after dilution. The recall affects 7572 vials from Lot Numbers: 3D009AA02, 3D009AA09, 3D009AA10, and 3D009AA25, all with an expiration date of March 31, 2026. The recall was initiated on June 10, 2025, due to the drug being found subpotent, failing to meet established potency specifications. The product was manufactured by Immunocore Limited in the United Kingdom and distributed in the US by Immunocore Commercial LLC, based in Conshohocken, Pennsylvania.

The recall was voluntarily initiated by Immunocore LLC and classified by the FDA as Class II on September 3, 2025, which denotes a situation where use of the product may cause temporary or medically reversible adverse health consequences, with a low likelihood of serious injury. While the company did not issue a press release, consignees were notified through appropriate channels. The product was distributed nationwide in the United States, highlighting the importance of pharmacist and clinician vigilance in identifying and removing the affected lots from clinical use.

KIMMTRAK (tebentafusp-tebn) is a T cell receptor (TCR) therapeutic indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma, a rare and aggressive form of eye cancer. As a biologic therapy intended for a precision-targeted patient population, potency is essential for ensuring therapeutic efficacy and optimizing immune-mediated tumor destruction.