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ACTIVE RECALL — CLASS IIActive recallD-0163-2026/FDA enforcement
Dermarite Industries, LLC·Cosmetics·Aug 27, 2025

Dermakleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, Packaged In…

What you need to know

Class II

  • What happened

    CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. Current good manufacturing practice failures can affect product identity, strength, quality or purity.

  • Action required

    Stop applying or using the product. Check the UPC and lot codes below, then return it to the retailer or contact the manufacturer about a refund or replacement.

Active recall · classified by the FDANationwide (US)More cosmetics

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Product identification

Source: FDA COSMETICS

Brand nameDermarite Industries, LLC
Recalling firmDermarite Industries, LLCNorth Bergen, NJ, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • All lots on or before expiry date 08/2027
Distribution area
Nationwide

Nationwide in the USA

United States

Quantity affected7, 736 tubes
Recall initiationFDA report date: November 26, 2025
FDA recall numberD-0163-2026

Beyond the headline

The recall, in context

Dermarite Industries, LLC initiated this cosmetics recall on August 27, 2025. The FDA enforcement report states: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. The FDA report lists distribution as: Nationwide in the USA.

The FDA enforcement report describes the reason as: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Dermakleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, Packaged In… was made or distributed by Dermarite Industries, LLC in North Bergen, NJ, United States. This page reflects FDA report D-0163-2026, dated November 26, 2025.

Why this is a Class II recall

Class II means the product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. In this recall, current good manufacturing practice failures can affect product identity, strength, quality or purity.

FDA definition

The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote.

What to do now

  1. 1

    Stop using it

    Set the product aside and do not apply it.

  2. 2

    Check the codes

    Compare the lot and date codes against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Product safety recall

Symptoms to watch for

The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.

Higher-risk groups

Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.

What to do now

  1. 1Stop using or eating the product and keep it away from children and pets.
  2. 2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
  3. 3Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Read the official source record for the specific hazard and instructions.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Dermakleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, Packaged In… recall?

Dermarite Industries, LLC recalled Dermakleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, Packaged In… in an FDA Class II enforcement action reported as D-0163-2026. CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

What should I do if I bought this product?

Stop applying or using the product. Check the UPC and lot codes below, then return it to the retailer or contact the manufacturer about a refund or replacement. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Is the Dermarite Industries, LLC recall still active?

Yes. As of the latest FDA enforcement report, this recall is listed as ongoing. Check the official source record for the most current status before making a decision.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record D-0163-2026. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

Brand history

More recalls by Dermarite Industries, LLC

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Ultrasure Anti-perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 ML (4 FL

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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Class I·

Dermarite Industries, LLC

Dermakleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), Packaged In…

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

Nationwide (US)Cosmetics

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.