# FDA recall D-0379-2021

> **SigmaPharm Laboratories LLC** · Class III · drug recall initiated 2021-04-19.

## Product

Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020    NDC 42794-016-10.

## 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

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0379-2021
- **Recalling firm:** SigmaPharm Laboratories LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-04-19
- **Report date:** 2021-05-26
- **Termination date:** 2022-09-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bensalem, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0379-2021

## Citation

> AI Analytics. FDA recall D-0379-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0379-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*