US FDA Publishes Final Guidance on Mandatory Cosmetic Recalls

The US Food and Drug Administration (FDA) published its final guidance on mandatory cosmetic recalls, setting out how the FDA may exercise its authority to require the recall of cosmetic products from the US market.

The guidance is part of the FDA’s ongoing implementation of the Modernisation of Cosmetics Regulation Act of 2022 (MoCRA), which gave the FDA the authority to order the recall of cosmetic products in certain circumstances. While cosmetic recalls are generally carried out voluntarily by companies, the guidance explains when the FDA may intervene and require a recall, how the process would work and what would be expected of businesses.

In particular, the FDA may require a recall where there is a reasonable probability that a cosmetic product is adulterated or misbranded and that it’s use or exposure could cause serious adverse health consequences. The guidance also explains the steps the FDA must take before issuing a mandatory recall order, including providing the responsible person with an opportunity to voluntarily cease distribution and recall the affected product.

The guidance was initially published in draft form in December 2025 and has now been finalised without substantive changes following the review of public comments. It does not introduce new recall power but provides further information on how the existing provisions under MoCRA will be applied.

Further information is available here FDA website.