Tebentafusp-tebn Recall: KIMMTRAK Injection 100 mcg/0.5 mL
Announced 2025-09-10 · FDA
The FDA is recalling 7,572 vials of KIMMTRAK (tebentafusp-tebn) Injection due to subpotent drug. The recall covers NDC 80446-0401-01 with lots 3D009AA09, 3D009AA10, 3D009AA25 and NDC 80446-0401-99 with lot 3D009AA02, all expiring 31 MAR 2026, distributed nationwide in the US. No corrective action is listed.
| Brand | IMMUNOCORE, LLC |
|---|---|
| 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 | Subpotent Drug |
| Severity | moderate |
| Units affected | 7572 |
| Distribution | US Nationwide |
| Agency | FDA |
| Recall / campaign no. | 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 |
WHAT YOU SHOULD DO
- Check your inventory for recalled KIMMTRAK vials using the listed NDCs and lot numbers and expiration dates.
- Do not use any recalled vials.
- Contact your healthcare provider or supplier to arrange return, disposal, or replacement per recall instructions.
- If you have used the product and have concerns, seek medical advice.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.