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 violation of labeling or manufacturing requirements that may cause temporary or medically reversible health issues. The specific hazard is regulatory non-compliance (lack of NDA/ANDA) rather than a direct physical or chemical hazard like contamination or injury.
Plain-English summary
Basic Reset Inc. is recalling 25 bottles of BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg. The product is distributed by Biogenyx, Inc. in Hendersonville, TN. The specific lot number is 1902411.25.
The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This indicates the product was distributed without the necessary regulatory authorization for marketing as a drug.
The product 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 Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
- Manufacturer
- Basic Reset Inc.
- Category
- Drug — CBD Product
- Hazard
- 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)
- Lots: 1902411.25
Distribution
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.
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