In March 2025, the U.S. Food and Drug Administration (FDA) announced the voluntary recall of numerous over-the-counter acne treatment products sold in stores and online because they were found with benzene, which is a known carcinogen. Benzene is associated with serious health risks, including an increased risk of cancer. The FDA's actions to recall these over-the-counter acne products occurred after testing in a laboratory found those acne treatment formulations to have higher benzene than expected levels. The recall included many over-the-counter products sold in retail stores and online across the United States.

FDA Recall of Acne Treatments Contaminated with Benzene (2025)

Recall , July 30, 2025

FDA Recall Announcement – March 2025

In March 2025, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of several over-the-counter acne treatment products that contain benzene, a known carcinogen, currently available to consumers both in stores and online throughout the U.S.

Health Risks of Benzene

Benzene exposure is associated with potentially serious health consequences, particularly increased cancer risk. Level of unacceptable benzene amounts were reported in several acne formulations tested in the FDA laboratory, resulting in an immediate FDA regulatory response.

FDA Response and Regulatory Action

To address consumer safety, the FDA moved quickly to mitigate public health risks and consumer complaints. Under its regulatory framework, the FDA instructed manufacturers and retailers to immediately remove affected products from physical and online marketplaces.

Consumer Responsibility

Consumers should check the acne treatment products they have, to see if they have affected lot numbers and expiration dates for the recall. Consumers should dispose of any contaminated products safely, and those who are impacted should report the product through the FDA’s recall notification process. [1]

FDA-Listed Acne Product Recalls due to Benzene Contamination (March 2025)

Brand

Product Name

Type

Issue

Recall Status

La Roche-Posay

Effaclar Duo Dual Action Acne Treatment

Acne Treatment

Contains benzene (known carcinogen)

Voluntary retail recall

Walgreens

Acne Control Cleanser

Cleanser

Contains benzene

Voluntary retail recall

Proactiv

Emergency Blemish Relief Cream

Blemish Cream

Contains benzene

Voluntary retail recall

Proactiv

Skin Smoothing Exfoliator

Exfoliator

Contains benzene

Voluntary retail recall

SLMD

Benzoyl Peroxide Acne Lotion

Acne Lotion

Contains benzene

Voluntary retail recall

Walgreens

Tinted Acne Treatment Cream

Acne Cream

Contains benzene

Voluntary retail recall

Zapzyt

Acne Treatment Gel

Acne Gel

Contains benzene

Voluntarily removed from shelves

Reasons for the Recall

The recall resulted from the discovery of benzene contamination in multiple batches of these acne treatment products. Benzene is a hazardous chemical that poses serious health hazards when absorbed through the skin in topical products or when inhaled. Benzene is a Class 1 carcinogen (i.e., known to cause cancer in humans), and even low cumulative exposure over time has been associated with:  

  • Leukemias and other cancers
  • Physical skin effects including irritation and rash.
  • Neurological effects including dizziness, headaches, and cognitive reduction.
FDA Recall of Acne Treatments Contaminated with Benzene blog

While benzene was detected in these acne treatments, it was not mentioned as an ingredient on the product labels, causing concern with unintentional consumer exposure. The FDA acted based on their ongoing responsibility to protect the public by continuing to evaluate and ensure the safety of them over the counter (OTC) products- particularly those used daily by large numbers of consumers.

Product name: Proactiv Emergency Blemish Relief Cream

Brand: Proactiv

Product: Blemish Relief Cream

Product image:

Treatemetn Cream

Source : Walgreens Tinted Acne Treatment Cream

Product example: Walgreens Tinted Acne Treatment Cream

Brand: Walgreens

Product: Tinted Acne Treatment Cream

Product image:

Source : Proactiv Emergency Blemish Relief Cream

 

Health Risks from Benzene

Exposure to benzene, mainly in products applied directly to skin, can result in:

  • Carcinogen:

Long-term exposure to benzene has a well-established association with leukemia and other blood cancers.

  • Skin reactions:

Benzene causes rashes, swelling, and other allergic reactions upon contact with skin.

  • Neurological Effects:

Short-term exposure results in dizziness, nausea, and confusion.

  • Organ toxicity:

Long-term exposure to benzene is associated with damage to vital organs (e.g., liver and kidneys).

Consumers should be aware of the risks of continued usage of the recalled products, even if the benzene levels of the contaminants are only at a very low concentration.

FDA Fed Benzo

The FDA moved forward with regulatory action after it validated their findings of benzene contamination.

Voluntary recall:

The FDA facilitated voluntary recalls of acne related treatment products with manufacturers. The batches and lot code numbers attached to the product recalls will ensure the products are no longer for sale to restrict possible exposure for consumers.

Retailers:

The FDA requested all retailers, and online sellers cease selling the recalled products immediately to ensure no one else can purchase any additional units for use.

Consumer Guidelines:

Consumers who purchased the affected products are encouraged to:

  • Stop using the products immediately as they are recalled.
  • Check lot numbers and expiry date and dispose of the affected products as instructed if they have any.

Report adverse reactions (skin irritation, dizziness, etc.) to the Food and Drug Administration Med Watch Adverse Event Reporting

Consumer Safety Alert

The FDA issued a consumer safety alert on recalls and further clarified actions consumer’s that purchased the affected acne products should take:

Stop using:

  • Consumers should stop use of acne products immediately as they recalled. Return or dispose.
  • Consumers should return the affected products to the merchant or dispose of them according to the manufacturer’s instructions.

Seek health care advice:

If consumers experience any negative effects, skin irritation, rashes, dizziness being some examples, care or advice from a health care provider is warranted.

Report adverse events:

All adverse health events from the use of the recalled products must be reported directly to the FDA MedWatch Adverse Event Reporting program.

To ensure your cosmetic products meet the best safety standards, contact Food Research Lab for their expert formulation and compliance services. Protect your brand, and your consumers with Food Research Lab.