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).
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 (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.
- Category
- Drug — Cosmetic/Drug Hybrid
- 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
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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