# FDA recall D-0197-2020

> **Basic Reset Inc.** · Class II · drug recall initiated 2019-10-18.

## Product

BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

## Reason for recall

Marketed without an Approved NDA/ANDA

## Distribution

United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

## Key facts

- **Recall number:** D-0197-2020
- **Recalling firm:** Basic Reset Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-18
- **Report date:** 2019-11-13
- **Termination date:** 2021-10-27

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Hendersonville, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0197-2020

## Citation

> AI Analytics. FDA recall D-0197-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0197-2020. Source: US FDA. Licensed CC0.

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