Medications & Supplements/Topical Products

Skincell Mole & Skin Corrector Serum Recalled for Unapproved Drug Marketing

Agency Publication Date: October 7, 2022

Summary

Justified Laboratories is recalling all lots of Skincell Mole & Skin Corrector Serum (1 fl. oz./30 mL jars). This product was marketed as a treatment for moles and skin corrections without required FDA approval for safety and effectiveness. No incidents or injuries related to this product have been reported to date.

Risk

These products are unapproved new drugs that have not undergone FDA evaluation for safety or efficacy. Using unapproved topical treatments for moles and skin lesions can lead to skin damage or a failure to properly diagnose and treat serious underlying skin conditions.

What You Should Do

This recall affects Skincell Mole & Skin Corrector Serum (1 fl. oz./30 mL jars) distributed by Justified Laboratories, Arlington, Texas.
Identify affected products by checking for UPC codes 810077532201 or 810077532218. All lots currently within their expiration dates are included in this recall.
If you have health concerns regarding the use of this product, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Justified Laboratories for further instructions.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Skincell Mole & Skin Corrector Serum (1 fl. oz./30 mL)

UPC Codes:

810077532201

Lot Numbers:

All lots remaining within expiry

Recall #: D-0008-2023

Product: Skincell Mole & Skin Corrector Serum (1 fl. oz./30 mL)

UPC Codes:

810077532218

Lot Numbers:

All lots remaining within expiry

Recall #: D-0009-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90828

Status: Resolved

Manufacturer: Justified Laboratories

Manufactured In: United States

Units Affected: 2 products (Unknown; Unknown)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Skincell Mole & Skin Corrector Serum (1 fl. oz./30 mL jars) distributed by Justified Laboratories, Arlington, Texas.

Identify affected products by checking for UPC codes 810077532201 or 810077532218. All lots currently within their expiration dates are included in this recall.

If you have health concerns regarding the use of this product, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Justified Laboratories for further instructions.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Skincell Mole & Skin Corrector Serum (1 fl. oz./30 mL)

UPC Codes:

810077532201

Lot Numbers:

All lots remaining within expiry

Recall #: D-0008-2023

Product: Skincell Mole & Skin Corrector Serum (1 fl. oz./30 mL)

UPC Codes:

810077532218

Lot Numbers:

All lots remaining within expiry

Recall #: D-0009-2023