# FDA recall D-0614-2025

> **IMMUNOCORE, LLC** · Class II · drug recall initiated 2025-06-10.

## Product

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

## Reason for recall

Subpotent Drug

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-0614-2025
- **Recalling firm:** IMMUNOCORE, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-10
- **Report date:** 2025-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Conshohocken, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0614-2025

## Citation

> AI Analytics. FDA recall D-0614-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0614-2025. Source: US FDA. Licensed CC0.

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