Why it was recalled
Subpotent Drug
Product description
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
Lot numbers, UPCs & expiration codes
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 sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0614-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 10, 2025
- FDA report date
- Sep 10, 2025
- Quantity
- 7,572 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- IMMUNOCORE, LLC
Original FDA data
Every field from FDA enforcement report D-0614-2025, exactly as published.
Show all FDA fields
- City
- Conshohocken
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97329
- Address
- Six Tower Bridge
- Address (line 2)
- 181 Washington St Ste 540
- Code information
- 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
- Postal code
- 19428-2068
- Report date
- Sep 10, 2025
- Product type
- Drugs
- Recall number
- D-0614-2025
- Classification
- Class II
- Recalling firm
- IMMUNOCORE, LLC
- Product quantity
- 7,572 vials
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US Nationwide
- Recall initiation date
- Jun 10, 2025
- Center classification date
- Sep 3, 2025