FDA Drug recall D-0380-2021
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
- FDA Drug
- Class III
- terminated
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class III recall of Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10 by Sigmapharm Laboratories, citing incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0380-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-04-19 |
| Published | 2021-05-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sigmapharm Laboratories |
| Distribution | US |
Product
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
Reason
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Identifiers
| ndc | 42794-016-22 |
|---|---|
| ndc | 42794-016-08 |
| ndc | 42794-016-10 |
| ndc | 42794-017-22 |
| ndc | 42794-017-08 |
| ndc | 42794-017-10 |
| code_info | Lots # 2012801, 2012901, 2013001 & Lot 2100501, Exp AUG 2022; 2100101, Exp NOV 2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0380-2021%22
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