Asenapine Sublingual Tablets — Class III drug recall D-0380-2021
Terminated recall by SigmaPharm Laboratories LLC, reported 2021-05-26, distributed nationwide. Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent i
| Recall number | D-0380-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SigmaPharm Laboratories LLC, Bensalem, PA, United States |
| Recall initiated | 2021-04-19 |
| Classified | 2021-05-14 |
| Reported by FDA | 2021-05-26 |
| Terminated | 2022-09-26 |
| Distributed | Nationwide (US) |
| Quantity | 8,786 bottles |
| NDC | 42794-0016, 42794-0016-08, 42794-0016-10, 42794-0016-22, 42794-0017, 42794-0017-08, 42794-0017-10, 42794-0017-22 |
| Lot numbers | 2012801, 2012901, 2013001, 2100101, 2100501 |
| Expiration dates | 2022-08-20, 2022-11-20 |
Product
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
Reason for recall
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
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-0380-2021. 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.