FDA Recall D-0532-2023

Pfizer Inc. · New York, NY

Class III Ongoing 1163 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02

Lot / code: Lot W054586A, EXP 03/2026

Quantity: 1,926 Bottles

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.

Recall record

Recall number: D-0532-2023
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2023-03-08
Classified by FDA Center: 2023-04-13
FDA published: 2023-04-19
Recalling firm: Pfizer Inc.
Firm location: New York, NY

Drug identification

Brand name(s): MEKTOVI
Generic name(s): BINIMETINIB
Manufacturer(s): Array BioPharma Inc.
NDC(s): 70255-010
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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