FDA Finalizes Rules for Mandatory Cosmetics Recalls

The FDA can now force a beauty brand to recall an unsafe product, and the agency has just explained exactly how. On October 23, the U.S. Food and Drug Administration announced final guidance in the Federal Register, detailing when and how it will order mandatory recalls of cosmetics — an authority it gained for the first time under the Modernization of Cosmetics Regulation Act of 2022, known as MoCRA.

The document, Questions and Answers Regarding Mandatory Cosmetics Recalls, finalizes a draft released in December 2025. The FDA received seven public comments on the draft, described them as "broadly supportive," and published the final version "as drafted with no substantive changes."

What changed after 85 years?

For decades, cosmetic recalls in the U.S. were voluntary. The FDA could ask a company to pull a product. It could not make it. MoCRA, signed into law in December 2022 as the biggest overhaul of cosmetics regulation since 1938, changed that. The new guidance spells out how the agency plans to use its new leverage. 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."

What triggers a mandatory recall?

The FDA must find a "reasonable probability" of two things at once: that a product is adulterated or misbranded, and that using or being exposed to it will cause "serious adverse health consequences or death." A product counts as 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. It can also weigh whether likely users are especially vulnerable — infants, pregnant women, the elderly or people who are medically compromised.

How does the process work?

The company named on the label always gets the first chance to stop distribution and recall the product voluntarily. If it refuses, or fails to act within the time the FDA sets, the agency can order an immediate halt to distribution. The company then gets an informal hearing within 10 days. After that, the FDA can drop the order, extend it, or convert it into a formal recall with a set timetable and required progress reports. Only the FDA Commissioner can order a recall, and that power cannot be delegated.

A mandatory recall comes with a public press release naming the product and describing the risk, and, where practical, pointing out similar products that are not affected. A company that ignores an order could face an injunction or criminal prosecution.

What's covered — and what isn't?

The rules apply to cosmetics only. Products also regulated as drugs or medical devices, such as sunscreens and dandruff shampoos, fall under separate recall authorities. 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 sits on the agency's website. Brands that once could stall on a voluntary recall now face a commissioner with a legal crowbar — and, for the first time since 1938, nowhere to hide.