The U.S. Food and Drug Administration (FDA) has finalized guidance explaining when and how it can order a mandatory recall of a cosmetic product, a power the agency gained for the first time under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The guidance, Questions and Answers Regarding Mandatory Cosmetics Recalls, was announced in the Federal Register on October 23 and finalizes a draft the agency released in December 2025. The FDA said it received seven public comments on the draft, which it described as “broadly supportive,” and published the final version “as drafted with no substantive changes.”
For decades, cosmetic recalls in the U.S. were voluntary: the FDA could ask a company to pull a product, but it couldn’t make it. MoCRA, signed into law in December 2022 as the biggest overhaul of cosmetics regulation since 1938, changed that, and the new guidance spells out how the agency plans to use the authority. The FDA says it still expects most problem products to be recalled voluntarily.
“This isn’t a complete shift from a voluntary recall system to a mandatory recall system,” explains cosmetic chemist Kelly Dobos. “It formalizes a backstop that FDA can use in the really rare situation where a company declined to take action.”
Under the guidance, the FDA must find a “reasonable probability” both that a product is adulterated or misbranded and that using it or being exposed to it will cause “serious adverse health consequences or death.” A product can be considered adulterated if it contains a harmful substance, was made under unsanitary conditions, contains an unapproved color additive or lacks adequate substantiation of its safety. In weighing a case, the agency may consider inspection findings, lab results, serious adverse event reports and consumer complaints, as well as whether the people likely to use the product are especially vulnerable, such as infants, pregnant women, the elderly or people who are medically compromised.
The company named on the label always gets the first chance to stop distribution and recall the product voluntarily. If it refuses or doesn’t act within the time the FDA sets, the agency can order it to immediately stop distributing the product, and the company is then offered an informal hearing within 10 days. After that, the FDA can drop the order, extend it or turn it into a formal recall with a set timetable and required progress reports. Only the FDA Commissioner can order a recall, and that power can’t be delegated.
For a mandatory recall, the FDA says it will issue a press release naming the product and describing the risk, and, where practical, pointing out similar products that aren’t affected. A company that ignores an order could face an injunction or criminal prosecution.
The rules apply to cosmetics only. Products that are also regulated as drugs or medical devices, such as sunscreens and dandruff shampoos, fall under separate recall authorities, and soap is excluded.
“When there’s a serious safety issue with a beauty product, getting it off the market shouldn’t depend entirely on whether the company agrees to recall it,” says Dallas dermatologist Elizabeth Houshmand, MD. “This gives FDA a way to step in if a brand won’t act. That’s an important protection for consumers and the products they use every day.”
The guidance is nonbinding and reflects the FDA’s current thinking. The full text is available on the FDA’s website.
