KIMMTRAK (tebentafusp-tebn) Injection recall
FDA recall D-0614-2025 · initiated Jun 10, 2025
IMMUNOCORE, LLC recalled KIMMTRAK (tebentafusp-tebn) Injection in Jun 2025 — an FDA Class II recall (D-0614-2025) because Subpotent Drug.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 7,572 vials
Details
- 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
- Recalling company
- Immunocore Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide
- Initiated
- Jun 10, 2025
- FDA report date
- Sep 10, 2025
Frequently asked
- Was KIMMTRAK (tebentafusp-tebn) Injection recalled?
- IMMUNOCORE, LLC recalled KIMMTRAK (tebentafusp-tebn) Injection in Jun 2025 — an FDA Class II recall (D-0614-2025) because Subpotent Drug. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was KIMMTRAK (tebentafusp-tebn) Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0614-2025 was: Subpotent Drug
- Is a recalled KIMMTRAK (tebentafusp-tebn) Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of KIMMTRAK (tebentafusp-tebn) Injection are affected?
- Distributed: US Nationwide. The recall covers these lots — 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. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0614-2025.