L’Oréal SA has voluntarily recalled all lots of its Effaclar Duo in the US over concerns that it may contain cancer-causing chemicals.
The acne treatment is produced under the beauty company’s La Roche-Posay skin care brand and contains benzoyl peroxide (BPO).
Benzene is a known carcinogen that can form at high levels in products containing BPO, which is a common ingredient used for killing acne-causing bacteria.
“In close coordination with the FDA, we have proactively decided to remove the limited remaining units of the current formula of Effaclar Duo from retailers,” L’Oréal SA said in a statement to Bloomberg.
“This decision also enables a seamless transition to our new and improved Effaclar Duo formula, which has been in development since 2024 and will be available to consumers soon.”
It comes after US lab Valisure found high levels of benzene in acne treatments containing BOP made by a number of companies.
Last year, the independent lab filed a petition with the US Food and Drug Administration (FDA) calling for the regulator to recall products, conduct an investigation and revise industry guidance.
The FDA has not yet responded to the petition.
Six class action lawsuits have since been filed against L’Oréal concerning products made by two of its brands, La Roche-Posay and CeraVe, alleging they contain unsafe levels of benzene.
Results from Valisure’s tests showed that on-market BPO products can form over 800 times the FDA concentration limit of two parts per million (ppm) for benzene.
High levels of benzene were not only detected inside BPO products, but also in the air around incubated BPO products, showing that benzene can leak out of some product packages and pose a potential inhalation risk.
Benzene exposure (either via inhalation, orally or through the skin) can potentially result in cancers such as leukaemia and blood cancer of the bone marrow, as well as blood disorders that can be life threatening.
There have been a spate of recalls connected to fears over benzene levels in aerosols in recent years, including dry shampoos and spray-on sun care.
But where these have been linked to manufacturing errors, BPO is an ingredient added directly to products intentionally, making the issue potentially more serious according to experts.
Valisure’s co-founder and President, David Light, said at the time its findings were published: “This discovery of benzoyl peroxide’s fundamental instability and formation of benzene is substantially different than Valisure’s previous findings of benzene in sunscreens, hand sanitisers and other consumer products.
“The benzene we found in sunscreens and other consumer products were impurities that came from contaminated ingredients; however, the benzene in benzoyl peroxide products is coming from the benzoyl peroxide itself, sometimes at hundreds of times the conditional FDA limit.
“This means the problem broadly affects benzoyl peroxide products, both prescription and over-the-counter, and necessitates urgent action.”