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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

La Roche-Posay Effaclar Acne Treatments Recalled for Benzene Contamination

Agency Publication Date: May 9, 2025
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Summary

L'Oreal USA is recalling approximately 2,241,261 units of La Roche-Posay Effaclar Duo Dual Action Acne Treatment (benzoyl peroxide) and Effaclar Dermatological Acne System kits. The recall was initiated because trace levels of benzene, a human carcinogen, were detected in some lots. While the contamination was initially found in a specific batch, the company is voluntarily recalling all lots of the Effaclar Duo products out of an abundance of caution.

Risk

Benzene is a known human carcinogen. Exposure to benzene can occur through inhalation, orally, and through the skin, potentially leading to an increased risk of cancers such as leukemia and blood disorders of the bone marrow. No injuries or adverse events have been reported to date in connection with this recall.

What You Should Do

  1. This recall affects La Roche-Posay Effaclar Duo Dual Action Acne Treatment (0.7 fl. oz. and 1.35 fl. oz. tubes) and the Effaclar Dermatological Acne System 3-step routine kits containing cleanser, toner, and acne treatment.
  2. Check the lot number and expiration date printed on the bottom flap of the product carton or on the crimp of the plastic tube. This recall affects over 100 distinct lot numbers with expiration dates between March 2025 and June 2026. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information regarding this safety alert.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: La Roche-Posay Effaclar Duo Dual Action Acne Treatment (1.35 fl. oz. / 40 mL)by La Roche-Posay
Variants: 5.5% Benzoyl Peroxide, Tube
UPC Codes:
883140500759
Lot Numbers (62):
MYX46W (Exp 04/30/2025)
MYX31W (Exp 03/2025)
MYX32W (Exp 03/2025)
MYX33W (Exp 03/2025)
MYX34W (Exp 03/2025)
MYX35W (Exp 03/2025)
MYX40W (Exp 03/2025)
MYX41W (Exp 04/2025)
MYX42W (Exp 04/2025)
MYX44W (Exp 04/2025)
MYX45W (Exp 04/2025)
MYX47W (Exp 04/2025)
MYX48W (Exp 04/2025)
MYX49W (Exp 04/2025)
MYX50W (Exp 05/2025)
MYX51W (Exp 05/2025)
MYX52W (Exp 05/2025)
MYX70W (Exp 06/2025)
MYX71W (Exp 06/2025)
MYX72W (Exp 07/2025)
MYX73W (Exp 07/2025)
MYX74W (Exp 07/2025)
MYX75W (Exp 07/2025)
MYX77W (Exp 07/2025)
MYX78W (Exp 07/2025)
MYX80W (Exp 08/2025)
MYX81W (Exp 07/2025)
MYX82W (Exp 08/2025)
MYX83W (Exp 08/2025)
MYX84W (Exp 07/2025)
MYXO0W (Exp 09/2025)
MYXO1W (Exp 08/2025)
MYXO3W (Exp 08/2025)
MYXO4W (Exp 09/2025)
MYXO5W (Exp 09/2025)
MYXO7W (Exp 09/2025)
MYXO8W (Exp 08/2025)
MYXO9W (Exp 09/2025)
MYXD0W (Exp 11/2025)
MYXD1W (Exp 12/2025)
MYXD2W (Exp 11/2025)
MYXD3W (Exp 11/2025)
MYXD4W (Exp 11/2025)
MYXD5W (Exp 11/2025)
MYXD6W (Exp 12/2025)
MYY22W (Exp 02/2026)
MYY23W (Exp 02/2026)
MYY30W (Exp 02/2026)
MYY31W (Exp 03/2026)
MYY32W (Exp 03/2026)

Benzoyl Peroxide Acne Medication

Product: La Roche-Posay Effaclar Duo Dual Action Acne Treatment (0.7 fl. oz. / 20 mL)by La Roche-Posay
Variants: 5.5% Benzoyl Peroxide, Tube
UPC Codes:
3606000508804
Lot Numbers:
MYX30W (Exp 03/2025)
MYX43W (Exp 04/2025)
MYX41W (Exp 04/2025)
MYX42W (Exp 04/2025)
MYX40W (Exp 04/2025)
MYX51W (Exp 05/2025)
MYX50W (Exp 05/2025)
MYX60W (Exp 05/2025)
MYX71W (Exp 06/2025)
MYX90W (Exp 08/2025)
MYX91W (Exp 09/2025)
MYX92W (Exp 08/2025)
MYXO0W (Exp 09/2025)
MYX93W (Exp 09/2025)
MYXD1W (Exp 11/2025)
MYXD2W (Exp 11/2025)
MYXDOW (Exp 09/2025)
MYXD4W (Exp 11/2025)
MYXD3W (Exp 11/2025)
MYY22W (Exp 02/2026)
MYY21W (Exp 02/2026)
MYY20W (Exp 02/2026)
MYY41W (Exp 04/2026)
MYY40W (Exp 04/2026)
MYY42W (Exp 04/2026)
MYY43W (Exp 04/2026)
MYY52W (Exp 05/2026)
MYY51W (Exp 05/2026)
MYY50W (Exp 05/2026)
MYY60W (Exp 06/2026)

Benzoyl Peroxide Acne Medication

Product: La Roche-Posay Effaclar Dermatological Acne System (3 Step Routine Kit)by La Roche-Posay
Variants: 3 Step Acne Routine Kit
UPC Codes:
883140035282
883140035275
Lot Numbers:
MYX30W (Exp 03/31/2025)
MYX32W (Exp 03/31/2025)
MYX33W (Exp 03/31/2025)
MYX41W (Exp 04/30/2025)
MYX42W (Exp 04/30/2025)
MYX43W (Exp 04/30/2025)
MYX44W (Exp 04/30/2025)
MYX45W (Exp 04/30/2025)
MYX50W (Exp 05/31/2025)
MYX51W (Exp 04/30/2025)
MYX52W (Exp 04/30/2025)
MYX53W (Exp 05/31/2025)
MYX70W (Exp 07/31/2025)
MYX80W (Exp 07/31/2025)
MYX81W (Exp 07/31/2025)
MYX90W (Exp 08/31/2025)
MYX91W (Exp 08/31/2025)
MYX92W (Exp 08/31/2025)
MYX93W (Exp 08/31/2025)
MYXD0W (Exp 09/30/2025)
MYXO1W (Exp 09/30/2025)
MYXO2W (Exp 09/30/2025)
MYXO3W (Exp 09/30/2025)
MYXO4W (Exp 09/30/2025)
MYXO5W (Exp 09/30/2025)
MYY21W (Exp 02/28/2026)
MYY23W (Exp 02/28/2026)
MYY26W (Exp 02/28/2026)
MYY27W (Exp 02/28/2026)
MYY31W (Exp 03/31/2026)
MYY32W (Exp 11/30/2025)
MYY33W (Exp 11/30/2025)
MYY34W (Exp 03/31/2026)
MYY50W (Exp 05/31/2026)
MYY51W (Exp 05/31/2026)
MYY60W (Exp 05/31/2026)
MYY61W (Exp 03/31/2026)
MYY62W (Exp 06/30/2026)
MYY63W (Exp 06/30/2026)
MYY64W (Exp 06/30/2026)
MYY72W (Exp 06/30/2026)
MYY73W (Exp 06/30/2026)
MYY74W (Exp 06/30/2026)
MYY75W (Exp 06/30/2026)
MYY76W (Exp 06/30/2026)

Kit includes Gel Cleanser, Clarifying Solution, and Acne Treatment

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96390
Status: Active
Manufacturer: L'Oreal USA
Sold By: Retailers nationwide
Manufactured In: United States, France
Units Affected: 2 products (2,226,801 bottles; 14,460 bottles)
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

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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 ยท 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.