MEKTOVI — Class III drug recall D-0532-2023
Ongoing recall by Pfizer Inc., reported 2023-04-19, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March
| Recall number | D-0532-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2023-03-08 |
| Classified | 2023-04-13 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 1,926 bottles |
| Reason classes | labeling |
| NDC | 70255-0010, 70255-0010-02, 70255-0010-03 |
| Lot numbers | W054586A |
| Expiration dates | 2026-03 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0532-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.