The U.S. Food and Drug Administration (FDA) issued the final guidance “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry” as part of our ongoing activities to implement the provisions added or required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This guidance clarifies the FDA’s mandatory recall authority for cosmetics under section 611 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by MoCRA. After reviewing public comments on the draft guidance issued on December 18, 2025, the agency is finalizing the guidance with no substantive changes from the draft guidance.
The final guidance provides information on:
- When FDA may order a mandatory recall.
- The process the FDA will follow when implementing a mandatory recall.
- Expectations for industry compliance with mandatory recall orders.
The FDA continues to encourage companies to voluntarily recall violative cosmetics on the market. For more information on cosmetics guidance and regulation, visit the FDA Cosmetics page.