The Recall Desk
HighFDA (Drugs)·D-0009-2023·Announced 2022-10-19

Skincell Mole & Skin Corrector Serum Recalled Due to Unapproved Drug Status

Justified Laboratories is recalling Skincell Mole & Skin Corrector Serum because it was marketed without FDA approval. The affected product was distributed throughout the United States, Puerto Rico, and Canada.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for an unapproved drug, representing a risk-of-harm product where safety and efficacy have not been established through FDA review. No illnesses or injuries have been reported, which prevents the classification from reaching 'Severe' or 'Critical' per the rubric.

Plain-English summary

Justified Laboratories is recalling Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars (UPC 8 10077 53221 8), because the product was marketed and distributed without an FDA-approved new drug application (NDA/ANDA). This regulatory violation means the product's safety and efficacy have not been evaluated by the FDA.

The affected product was distributed in the United States, including Puerto Rico, and Canada. All lots within their expiration date are included in this recall.

Consumers who have purchased this product should stop using it immediately. If you have experienced any skin reactions or other health concerns after using this product, contact a healthcare provider. The product should be disposed of or returned to the place of purchase for a refund.

The recalled product

Product
Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8
Manufacturer
Justified Laboratories
Category
Drug — Topical / Over-the-Counter
Hazard
  • unapproved-drug

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 lots remaining within expiry.

Distribution

Distribution scope not specified by the agency.

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