1. Home
  2. Cosmetics
  3. Cosmetics Compliance & Enforcement
  4. FDA Recall Policy for Cosmetics
  1. Cosmetics Compliance & Enforcement

FDA Recall Policy for Cosmetics

What's New

December 18, 2025

The FDA announces the availability of a draft guidance document entitled "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry."

This draft guidance, when finalized, will aim to provide clarity on the FDA's mandatory recall authority for cosmetics under section 611 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

A recall is a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws we administer and against which we would initiate legal action, such as seizure [Title 21 of the Code of Federal Regulations (CFR), section 7.3(g)]. Most recalls of cosmetics generally occur voluntarily in accordance with 21 CFR part 7. The FDA continues to encourage firms to voluntarily recall violative cosmetics and expects most violative cosmetics will continue to be voluntarily recalled. MoCRA added section 611 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), providing the FDA with mandatory recall authority over cosmetics. If the agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, the FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily. 

21 CFR Part 7 generally provides the FDA’s recall policy, primarily for voluntary recalls, including the components of a recall strategy. The following provides further information on recalls of cosmetics.

What is the FDA's role in a recall?

Typically, a firm can voluntarily initiate a recall, or the FDA can request that a firm voluntarily recall a product. If certain criteria are met, the FDA can order a responsible person to cease distribution and recall cosmetic (i.e., a “mandatory recall”). For more information, please refer to the section below: What is the FDA’s mandatory cosmetic recall authority?). 

The following are examples of the FDA’s roles in the context of a voluntary recall:

  • We monitor the progress of a recall reviewing firm status reports [21 CFR 7.53]. The recalling firm will ordinarily be responsible for conducting effectiveness checks, but the FDA will assist in this task where necessary and appropriate. [21 CFR 7.42(b)(3)].

  • We evaluate the health hazard [21 CFR 7.41] presented by the product under recall and assign a classification to indicate the degree of hazard posed by such a product [21 CFR 7.3(m)]:

    • Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
    • Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
    • Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

    The FDA includes the recall classification in the FDA’s Enforcement Reports, a weekly public notification that the FDA issues with general information about recalls [see 21 CFR 7.50].   

  • If we believe that a public warning is necessary, (i.e., when a recalled product presents a serious hazard to health and where other means for preventing the use of a recalled product appear inadequate), we ensure that either the FDA or the firm issues the public warning [21 CFR 7.42(b)(2)]. In some situations, for example if a firm is unwilling to issue a public warning, unduly delays issuing one, or issues one that is deficient in any respect, the FDA may issue a public warning on its own initiative, or supplement or correct a public warning with its own public warning.
  • If we request a recall, we will develop a recommended strategy for each recall, including the necessity for any public warning. If the firm develops a recall strategy, we review and recommend changes, as appropriate, for that strategy [21 CFR 7.42]. A recall strategy should take into account several factors as outlined in 21 CFR 7.42(a)(1)(i-v).  
  • We make sure that all reasonable efforts have been made to remove or correct the recalled product in accordance with the recall strategy, before providing written notification that a recall is terminated [21 CFR 7.55].

What is a cosmetic firm's responsibility in a recall?

Under the guidelines in 21 CFR Part 7, you should do the following in the context of a voluntary recall:

  • You should notify your customers. The content, format, and extent of notification should be commensurate with the hazard presented by the product and the recall strategy developed for the product, as detailed in 21 CFR 7.49.
  • When you initiate a recall, you should notify the appropriate FDA Office of Inspections and Investigations (OII) Division office [21 CFR 7.46(d)].
  • You should submit periodic recall status reports to the appropriate FDA OII Division office so that we may assess the progress of the recall [21 CFR 7.53]
  • If your firm decides to issue its own public warning, you should submit such a statement and plan for its distribution to the FDA for review and comment [21 CFR 7.42(b)(2)].
  • You should conduct effectiveness checks, as described in 21 CFR 7.42(b)(3).
  • You should evaluate your recall for termination when all possible customer responses have been received and it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product [see 21 CFR 7.55(a)].
  • You may request termination of your recall by submitting a written request to the appropriate FDA OII Division office [21 CFR 7.55(b)].

How can a cosmetic firm make the recall process easier and more effective?

The best way to minimize the burden of product recalls is to do a thorough job of preventing product adulteration and misbranding to begin with. But in case a recall does become necessary, companies can minimize the disruptiveness by being prepared in advance. The following are some guidelines:

  • Prepare and maintain a contingency plan for initiating a recall in accordance with the recall regulations. Refer to 21 CFR Part 7 to determine the steps you should incorporate into this plan [21 CFR. 7.59(a)].
  • Use sufficient coding, such as production lot and/or batch numbers, to make possible positive lot identification and to facilitate effective recall of all violatice lots [21 CFR 7.59(b)]. Lot numbering is not required by law for cosmetics. However, it allows you to determine whether some or all lots of a product need to be recalled. 
  • Maintain adequate distribution records to facilitate location of products being recalled. Maintain distribution records for a period of time exceeding the shelf life and expected use of the product [21 CFR 7.59(c)].

What should a cosmetic firm do to prevent the manufacture and distribution of violative products?

In addition to the corrective actions of removing a violative product from the market and either destroying it or bringing it into compliance, you should take the kind of corrective actions that prevent a similar problem from occurring in the future. For example, you should--

  • determine why the violation occurred,
  • determine what changes you should make to keep the problem from happening again, and
  • implement those changes.

These are some of the things an FDA investigator will look for if we conduct an inspection related to a recall. To learn more about what to expect during a recall-related inspection, you may check refer to the FDA's Investigations Operations Manual, Chapter 8, "Investigations." To learn more about FDA's policies and procedures regarding recalls, you may refer to the FDA's Regulatory Procedures Manual, Chapter 7, "Recall Procedures."

What is the FDA’s mandatory cosmetic recall authority?

(MoCRA) expanded the FDA’s authority to regulate cosmetics. Among other provisions, MoCRA added section 611 to the FD&C Act, providing the FDA with mandatory recall authority over cosmetics. Section 611 of the FD&C Act gives the FDA the authority to order a responsible person (as defined in section 604 of the Act) to cease distribution and recall a cosmetic if it determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of exposure to such cosmetic will cause serious adverse health consequences or death, and the responsible person fails to voluntarily cease distribution and recall the product when provided the opportunity.

As defined in section 604 of the FD&C Act, a responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. 

The FDA has announced the availability of a draft guidance document entitled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.” This draft guidance, when finalized, will aims to provide clarity on the FDA's mandatory recall authority for cosmetics under section 611 of FD&C Act).

More Resources

Updated July 29, 2002. This document is current. It is updated only as needed.

Back to Top