FDA Issues Draft Guidance on Mandatory Cosmetic Recalls

United Safety Agents
Dec 27, 2025
2 min read

FDA Issues Draft Guidance on

Mandatory Cosmetic Recalls

On December 18, 2025, The Food and Drug Administration (FDA) took another step in enhancing the safety of the cosmetics industry by releasing a Draft Guidance for Industry on Mandatory Cosmetic Recalls. This move further expands the Modernization of Cosmetics Regulation Act (MoCRA), which shifts the responsibility for recalls from companies to the FDA. Under MoCRA, the FDA now has the authority to mandate recalls for cosmetic products they deem adulterated or those that could cause serious health risks or even death. This change aims to increase transparency and ensure safer practices in the cosmetic sector.

The Draft Guidance addresses several common questions about FDA's new recall authority. It clarifies what qualifies as a cosmetic product under this authority, when a cosmetic is considered adulterated or misbranded, it outlines the types of serious adverse health consquences or fatalities that could trigger a recall. Additionally, the document details the steps the FDA will follow prior to issuing a recall, the process of a hearing by the responsible person and its possible outcomes, public notices, and recall terminations.

FDA Q&A Include:

To invoke mandatory recall, FDA must determine:
- there is a reasonable probability the cosmetic is adulterated; and
- there is a reasonable probability that the use of or exposure to the cosmetic will cause serious adverse health consequences or death.
Before ordering a mandatory recall, the FDA will first notify the responsible person and offer an opportunity to voluntarily stop distributing the product within a timeframe and manner specified by the agency. If the responsible person declines to take this action, the FDA may proceed with a mandatory recall.
An informal hearing may be granted to the responsible person no later than 10 days after the date of issuance FDA's recall.
An informal hearing may result in one of the following outcomes:
- The recall is vacated;
- The recall is continued; or
- The recall is amended.
The responsible person is required to notify all relevant parties involved in the manufacturing, distribution, importation, or sale of the recalled product.
FDA will ensure that a press release announcing the recall is issued, including, at a minimum, the product name, a description of the associated risk, guidance for consumers on similar unaffected products, and an image of the product posted on FDA’s website, along with any necessary alerts and public notices.
A recall will be terminated once FDA determines that appropriate actions have been taken to remove or correct the product in accordance with the recall strategy. FDA will then issue written notice to the responsible person confirming that the recall has been terminated.
Refusal or failure to follow mandatory cosmetic recall will be subjecy to injunction and/or criminal prosecution.