Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

KIMMTRAK (tebentafusp-tebn) Injection Recalled by IMMUNOCORE, LLC Due to Subpotent Drug

Date: June 10, 2025
Company: IMMUNOCORE, LLC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact IMMUNOCORE, LLC directly.

Affected Products

KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026

Quantity: 7,572 vials

Why Was This Recalled?

Subpotent Drug

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About IMMUNOCORE, LLC

IMMUNOCORE, LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report