Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
MEKTOVI (binimetinib)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was 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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
70255-0010-02
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Mektovi Binimetinib NDC 70255-0010 |
15 mg/1 | Tablet, Film Coated Oral |
Array BioPharma Inc. | Rx |
- Recalling firm
- Pfizer Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0532-2023 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
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All 2023 recalls
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All labeling / mix-up recalls
Class II · Moderate risk
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Nystatin 500 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 5bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
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