The Recall Desk
HighFDA (Drugs)·D-0008-2023·Announced 2022-10-19

Skincell Mole & Skin Corrector Serum recalled as unapproved drug

Justified Laboratories is recalling Skincell Mole & Skin Corrector Serum. The product was marketed as a drug without FDA approval (NDA/ANDA).

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: FDA Class II unapproved new drug with no reported illnesses or injuries. The product was marketed without FDA approval, making it a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Justified Laboratories is recalling Skincell Mole & Skin Corrector Serum (1 fl oz/30 mL jars, UPC 8 10077 53220 1) due to regulatory violations.

The product was marketed and distributed as a drug without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA. The product has not been evaluated for safety and efficacy.

The product was distributed throughout the United States, including Puerto Rico and Canada. All lots remaining within expiry are included in this recall.

Consumers who have purchased this product should discontinue use and contact the manufacturer or their healthcare provider with questions about the product.

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 53220 1
Manufacturer
Justified Laboratories
Category
Drug — Topical / Dermatological
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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