CLASS III ONGOING Drug recall · Reported 19 Apr 2023 · FDA Enforcement Report
Mektovi (binimetinib) tablets, 15 mg recalled by Pfizer
Pfizer is recalling Mektovi (binimetinib) tablets, 15 mg, distributed nationwide in the US. The recall was initiated on 8 Mar 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0532-2023
- FDA event ID
- 91872
- Recalling firm
- Pfizer, New York, NY
- Brand
- Mektovi
- Manufacturer
- Array BioPharma Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 8 Mar 2023
- FDA classified
- 13 Apr 2023
- Reported
- 19 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 8 Mar 2023 | Recall initiated by company | |
| 13 Apr 2023 | Classified by FDA | +36 days |
| 19 Apr 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot W054586A, EXP 03/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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