The Recall Desk
ModerateFDA (Drugs)·D-0197-2020·Announced 2019-11-13

Biogenyx CBD Oil Recalled for Lack of FDA Approval

Basic Reset Inc. is recalling Biogenyx CBD Oil because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The specific reason is regulatory (lack of approval) rather than a reported acute safety incident like injury or death.

Plain-English summary

Basic Reset Inc. is recalling 25 bottles of BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg. The product is distributed by Biogenyx, Inc. in Hendersonville, TN.

The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This means the product has not been evaluated by the FDA for safety, efficacy, or quality.

The affected product, identified by Lot 1902411.25, was distributed in the United States (including Puerto Rico and U.S. Virgin Islands), Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, and Greece. Consumers should stop using the product and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
Manufacturer
Basic Reset Inc.
Affected units
25

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 1902411.25

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 11 recalled by Basic Reset Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →