KIMMTRAK injection recalled after testing subpotent in three affected lots
KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, is recalled nationwide as a subpotent drug. 7,572 vials are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a subpotent infusion medicine may not deliver the intended dose and no injuries are reported.
Plain-English summary
KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, for intravenous infusion after dilution, in single-dose vials, made by Immunocore Limited in Abingdon, United Kingdom for Immunocore Commercial LLC, is being recalled. Affected lots under NDC 80446-0401-01 are 3D009AA09, 3D009AA10 and 3D009AA25, all with an expiry of 31 MAR 2026, along with non-commercial NDC 80446-0401-99 material listed in the notice. The recall covers 7,572 vials distributed nationwide.
The recall was issued because the product is subpotent. The FDA classified the action as Class II.
Hospitals and infusion centres holding these lots should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- 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…
- Manufacturer
- IMMUNOCORE, LLC
- Category
- Drug — Oncology
- Affected units
- 7,572
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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
Distributed nationwide across the United States.
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