CLASS II ONGOING Drug recall · Reported 10 Sep 2025 · FDA Enforcement Report
Kimmtrak (tebentafusp-tebn) Injection, 100 mcg recalled by Immunocore
Immunocore is recalling Kimmtrak (tebentafusp-tebn) Injection, 100 mcg/, For intravenous Infusion After Dilution, distributed nationwide in the US. The recall was initiated on 10 Jun 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0614-2025
- FDA event ID
- 97329
- Recalling firm
- Immunocore, Conshohocken, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jun 2025
- FDA classified
- 3 Sep 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Jun 2025 | Recall initiated by company | |
| 3 Sep 2025 | Classified by FDA | +85 days |
| 10 Sep 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
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
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.