The Recall Desk
ModerateFDA (Drugs)·D-0532-2023·Announced 2023-04-19

Prescription Drug Recall: Incorrect Expiration Date on MEKTOVI Labels

Pfizer recalls 1,926 bottles of MEKTOVI (binimetinib) due to incorrect expiration dates on labels. Bottles labeled March 2026 actually expire February 2025.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III labeling error with no reported illnesses or injuries. The hazard is a documentation-related error (incorrect expiration date printed on the label), fitting the rubric criterion of 'minor labeling errors.' Class III recalls typically score 1–2.

Plain-English summary

Pfizer Inc. is recalling 1,926 bottles of MEKTOVI (binimetinib) tablets, 15 mg (NDC 70255-010-02), lot W054586A, distributed nationwide in the USA. MEKTOVI is a prescription drug.

The recall is due to a labeling error. The carton and bottle labels incorrectly state an expiration date of March 2026, when the correct expiration date is February 2025. Patients who received medication with the incorrect label may have used an expired product.

Healthcare providers and patients who have received this lot should verify the actual expiration date. Expired medications should not be used. Patients should contact their healthcare provider with questions about their medication.

The recalled product

Product
MEKTOVI (BINIMETINIB)
Brand
MEKTOVI
Manufacturer
Pfizer Inc.
Hazard
  • labeling-error
  • incorrect-expiration-date

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 (2)

  • Lot W054586A
  • EXP 03/2026

Distribution

Distributed nationwide across the United States.