Basic Reset Recalls Miracle Facelift Masque for Lack of FDA Approval
Basic Reset Inc. is recalling Miracle Facelift Masque because it 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 temporary or medically reversible adverse health consequence. The specific hazard is regulatory non-compliance (lack of NDA/ANDA approval) rather than a specific physical or chemical hazard like contamination or injury.
Plain-English summary
Basic Reset Inc. is recalling Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, manufactured by Kim Kaufman Productions in Nashville, TN. The product is being recalled because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recall covers all units of the product. The distribution pattern includes 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 further instructions.
The recalled product
- Product
- Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN.
- Manufacturer
- Basic Reset Inc.
- Category
- Drug — Cosmetic/Drug Hybrid
- Hazard
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)
- ALL
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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