On October 22, 2026, the U.S. Food and Drug Administration (FDA) finalized its guidance on how it will use its power to order mandatory recalls of cosmetics. The guidance, Questions and Answers Regarding Mandatory Cosmetics Recalls, was announced in the Federal Register on October 23 and takes effect immediately. FDA made no substantive changes from the draft it released on December 18, 2025.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) gave FDA mandatory recall authority over cosmetics for the first time, as we noted in our May overview of MoCRA. The new guidance explains how that authority will work in practice: who receives an order, what FDA must prove, and what happens after an order is issued.
Who Receives a Recall Order
Orders go to the “responsible person”: the manufacturer, packer, or distributor whose name appears on the product label. For many imported cosmetics, that is the U.S. company listed on the label as distributor, not the overseas manufacturer. Importers that put their own name on product labels should assume they would be the party FDA contacts.
Soap is not covered, and neither are products regulated as both cosmetics and drugs, such as sunscreens and antiperspirants. Those products fall under FDA’s separate drug and device recall authorities.
What FDA Must Show
FDA can act only if it finds a reasonable probability of both of the following:
- The cosmetic is adulterated (for example, contaminated, made under insanitary conditions, or lacking adequate safety substantiation) or misbranded (for example, carrying false or incomplete labeling).
- Use of or exposure to the product will cause serious adverse health consequences or death.
FDA may rely on inspection findings, lab results on raw materials or finished products, adverse event reports, consumer and trade complaints, and whether the product is used by vulnerable groups such as infants, older adults, or pregnant women.
How the Process Works
- Voluntary first. FDA gives the responsible person written notice and a chance to stop distribution and recall the product voluntarily.
- Order to stop distribution. If the company refuses or does not act within the time FDA sets, FDA may order it to stop distributing the product immediately.
- Informal hearing. The company may request a hearing, which must be held within 10 days of the order.
- Final decision. After the hearing, FDA may cancel the order, keep it in place, or expand it into a full recall with a timetable and reporting schedule. Only the FDA Commissioner can order a recall, and that power cannot be delegated.
Ignoring an order is a prohibited act under federal law and can lead to an injunction or criminal prosecution.
Public Exposure
FDA can require the company to notify the public and everyone in the supply chain who makes, distributes, imports, or sells the product. For a mandatory recall, FDA will also issue its own press release naming the product and describing the risk, along with a product image when available. That means a mandatory recall carries brand risk well beyond the cost of pulling inventory.
Why It Matters
FDA expects most cosmetic recalls to remain voluntary, and the agency received only seven comments on the draft. But the guidance makes clear that a company that refuses to cooperate can now be forced to act, and that FDA will put the product’s name in front of the public. Responding quickly to an FDA request for a voluntary recall is the best way to keep control of the process.
What Importers Should Do Now
- Confirm whose name is on your product labels and who in your organization would receive and respond to an FDA notice.
- Build or update a written recall plan, including how you would notify customers and retailers.
- Keep distribution records that show where each lot went, so a recall can be traced quickly.
- Review complaint files and serious adverse event reports for issues that could trigger FDA attention.
- Make sure facility registrations, product listings, and safety substantiation records are current.
- Check products that may be regulated as drugs (sunscreens, antiperspirants) since different recall rules apply.
ASK Alba™: Questions about how MoCRA affects your cosmetics imports? Our trade compliance team can help you review labeling, registration, and recall readiness. Contact us today.
References
- FDA: Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry
- FDA guidance document (PDF)
- Federal Register: Notice of availability of final guidance (Doc. 2026-21679)
- Federal Register: Draft guidance notice, December 18, 2025 (90 FR 59129)
- Alba Wheels Up: FDA Expands Cosmetics Oversight Under MoCRA (May 5, 2026)
