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FDA's Final Guidance on Mandatory Cosmetic Recalls: What Foreign Brands Must Prepare For

MoCRA gave FDA the power to order cosmetic recalls. FDA's final question-and-answer guidance, issued in October 2026, explains when it can use that power, the steps it follows, and what a responsible person must do.

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FDABridge Regulatory Team
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Before the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA could only ask a cosmetic company to recall a product. MoCRA added section 611 to the Federal Food, Drug, and Cosmetic Act, which gives FDA the power to order a recall. In October 2026 FDA finalized its guidance, "Questions and Answers Regarding Mandatory Cosmetics Recalls" (docket FDA-2025-D-2246). The guidance explains how FDA intends to use the power. For brands outside the United States, it shows exactly who FDA will contact and what that company will be expected to do quickly.

Who receives the order: the responsible person

Section 611 orders are addressed to the "responsible person". MoCRA defines this as the manufacturer, packer or distributor of a cosmetic whose name appears on the product label. If your company's name is on the US label, you are the responsible person, even if your facility and staff are outside the United States. That is why the US label contact and your MoCRA records matter. Our guide to the US label contact requirement explains the label side.

Products that are both a cosmetic and a drug, such as sunscreen moisturizers or anti-dandruff shampoos, or both a cosmetic and a device, are not covered by section 611. They may instead be covered by other FDA recall authorities.

The two-part test FDA must meet

FDA can use the mandatory recall power only if it determines both of the following:

  • There is a reasonable probability that the cosmetic is adulterated under section 601 or misbranded under section 602 of the FD&C Act.
  • There is a reasonable probability that using or being exposed to the cosmetic will cause serious adverse health consequences or death.

When FDA makes that assessment, the factors it lists include available serious adverse event data and whether the responsible person has failed to voluntarily stop distribution. In practice, the adverse event file a brand keeps under MoCRA becomes evidence in any recall decision.

Step by step: how a mandatory recall unfolds

  1. Opportunity to act voluntarily. FDA first notifies the responsible person in writing and gives it the chance to stop distribution and recall the product voluntarily, within the time and manner FDA sets.
  2. Order to stop distribution. If the company refuses or does not act as required, FDA may order it to immediately stop distributing the cosmetic. FDA may also require the company to notify manufacturers, distributors, importers, retailers and the public.
  3. Informal hearing. The company receives an opportunity for an informal hearing, held no later than 10 days after the order is issued, under FDA's regulatory hearing procedures in 21 CFR Part 16. The hearing addresses whether there is adequate evidence for the order.
  4. Outcome. After the hearing opportunity, FDA vacates the order, continues the stop-distribution order until a set date, or amends it into a recall order with a timetable and a schedule of updates to FDA. Only the FDA Commissioner can order or vacate a recall under this step.
  5. Public communication. For an amended recall order, FDA ensures that a press release is published naming the product and describing the risk, and that, where available, an image of the product appears on FDA's website.
  6. Termination. FDA generally ends the recall under 21 CFR 7.55, once reasonable efforts have been made to remove or correct the product.

Ten days is very little time for a company that has to brief lawyers, gather batch records and find distribution data across time zones. Voluntary recalls under 21 CFR Part 7 remain the normal route, and acting quickly at step 1 usually avoids an order altogether. Our guide to FDA's recall process for foreign manufacturers explains how voluntary recalls work.

What a foreign brand should have ready

  • Batch-level distribution records showing which US importers, distributors, marketplaces and retailers received each lot.
  • A current adverse event file, with serious adverse events reported to FDA within 15 business days as MoCRA requires. Our article on the 15-business-day serious adverse event rule explains the deadline.
  • A named person who can receive FDA correspondence and make decisions quickly, and a US contact that answers.
  • Accurate MoCRA facility registration and product listings, so FDA and your partners can identify the product, its ingredients and the facility that made it.
  • A short recall plan: who decides, how customers are notified, how stock is held, and how affected units are destroyed or corrected.

The real lesson: problems start with unreported reactions

Mandatory recalls are reserved for serious risks, but they usually follow a pattern of consumer complaints that nobody escalated. Our case study of a skincare brand recall that followed an unreported reaction shows how that pattern develops. A brand that records every complaint, assesses whether it is serious and reports on time gives FDA a reason to rely on voluntary action.

FDABridge supports cosmetic brands with adverse event management, cosmetic facility registration and cosmetic product listing, so the records FDA would ask for are complete before anyone asks.

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