FDA Issues Final Guidance on Mandatory Recalls

The US Food and Drug Administration (FDA) issued a final guidance document for the cosmetic industry as part of the Agency’s ongoing activities to implement the provisions added or required by the Modernization of Cosmetics Regulation Act of 2022, commonly known as MoCRA.

The final guidance “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry” provides clarity on the FDA’s mandatory recall authority for cosmetics under section 611 of the Federal Food, Drug, and Cosmetic Act, as added by MoCRA. 

After reviewing public comments on the draft guidance issued on December 18, 2025, FDA finalized the guidance with no substantive changes from the draft.

FDA said it continues to encourage companies to voluntarily recall violative cosmetics.