The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0191-2020·Announced 2019-11-13

Basic Reset CBD Oil Recalled for Lack of FDA Approval

Basic Reset Inc. is recalling 554 bottles of CBD Reset 750 oil because the product was marketed without an approved FDA application.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 low probability of serious adverse health consequences. The specific hazard is regulatory non-compliance (lack of approval) rather than a reported acute physical injury or contamination.

Plain-English summary

Basic Reset Inc. is recalling 554 bottles of Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottles. The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The affected 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. The specific lot numbers involved are 1902411.25 and 1916911.25.

Consumers who have purchased this product should stop using it and contact Basic Reset Inc. for further instructions or a refund.

The recalled product

Product
Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
Manufacturer
Basic Reset Inc.
Affected units
554

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 (2)

  • Lots: 1902411.25
  • 1916911.25

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 →

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