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  5. FDA Recall: Asenapine

FDA Recall Asenapine

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Asenapine with NDC 42794-016 was initiated on 04-19-2021 as a Class III recall due to incorrect product formulation; product was manufactured with the incorrect art cherry flavor flavoring agent instead of art black cherry flavor flavoring agent The latest recall number for this product is D-0379-2021 and the recall is currently terminated as of 09-26-2022 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0379-202104-19-202105-26-2021Class III6266 bottlesAsenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.Terminated
D-0380-202104-19-202105-26-2021Class III8786 bottlesAsenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.