The Recall Desk
ModerateFDA (Drugs)·D-0190-2020·Announced 2019-11-13

Basic Reset Recalls Nuovi Firming Masque for Lack of FDA Approval

Basic Reset Inc. is recalling 339 bottles of Nuovi Firming Masque because the product 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 low probability of serious adverse health consequences. The specific hazard is regulatory (marketing without approval) rather than a direct physical or chemical contamination hazard with reported injuries.

Plain-English summary

Basic Reset Inc. is voluntarily recalling 339 bottles of Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 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 is identified by Lot 30995. The recall covers distribution 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 who have purchased this product should stop using it and contact Basic Reset Inc. for further instructions.

The recalled product

Product
Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA exclusively for Basic Reset 260 W. Main St., Ste 103 Hendersonville, TN 37075
Manufacturer
Basic Reset Inc.
Affected units
339

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: 30995

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 →