FDA finalizes Q&A guidance on mandatory cosmetic recalls under MoCRA

On October 23, 2026, FDA announced in the Federal Register the availability of a final guidance titled Questions and Answers Regarding Mandatory Cosmetics Recalls (docket FDA-2025-D-2246). The guidance explains how FDA will carry out section 611 of the FD&C Act, added by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which lets FDA order a responsible person to cease distribution and recall a cosmetic. It finalizes the draft announced on December 18, 2025. FDA received seven comments on the draft and made no substantive changes.

Under the guidance, FDA expects most violative cosmetics to keep being recalled voluntarily. A mandatory recall can follow when FDA finds a reasonable probability that a cosmetic is adulterated or misbranded and that its use will cause serious adverse health consequences or death, and the responsible person does not act voluntarily, with an opportunity for an informal hearing. Evidence FDA may weigh includes inspection observations, sample results for raw materials, finished cosmetics and environmental swabs from the facility, epidemiological data, the vulnerability of users, serious adverse event data and complaints. The guidance notes that the law's definition of a serious adverse event includes an infection.

This is guidance, which isn't legally binding. It describes the agency's current thinking.