Medications & Supplements/Prescription Drugs

MEKTOVI (binimetinib) Tablets Recalled for Incorrect Expiration Date

Agency Publication Date: April 13, 2023

Summary

Pfizer Inc. is recalling 1,926 bottles of MEKTOVI (binimetinib) 15 mg tablets because the labels show an incorrect expiration date. The bottles and cartons state a shelf life until March 2026, but the medication actually expires in February 2025. This recall affects the 180-count prescription bottles distributed nationwide by Array BioPharma Inc., a subsidiary of Pfizer.

Risk

Patients may unknowingly use the medication after its actual expiration date of February 2025, which could lead to reduced effectiveness or safety of the drug.

What You Should Do

This recall affects 180-count bottles of MEKTOVI (binimetinib) tablets, 15 mg, with NDC 70255-010-02, lot number W054586A, and a printed expiration date of 03/2026.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information about this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: MEKTOVI (binimetinib) tablets (180-count bottle)

Variants: 15 mg, 180-count bottle, Rx only

Lot Numbers:

W054586A (Exp 03/2026)

NDC:

70255-010-02

Recall #: D-0532-2023. The correct expiration date is February 2025.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91872

Status: Active

Manufacturer: Pfizer Inc.

Manufactured In: United States

Units Affected: 1,926 Bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.