Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Cosmetics Recalls & Alerts

Cosmetics Recalls & Alerts Home
          Cosmetics
          Cosmetics Compliance & Enforcement
          Cosmetics Recalls & Alerts
          FDA Recall Policy for CosmeticsCosmetics Recalls & Alerts FDA Recall Policy for Cosmetics
  
  	
    Share
    Post
    Linkedin

    Email
    PrintBack to Recalls & Alerts

A recall is a firm's removal or correction of a marketed product that 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)]. FDA strongly recommends that firms become familiar with the complete guidelines, including the components of a recall strategy, in 21 CFR Part 7. The following is an introduction.

What is FDA's role in a recall?
	What is a cosmetic firm's responsibility in a recall?
	How can a cosmetic firm make the recall process easier and more effective?
	What should a cosmetic firm do to prevent similar problems?What is FDA's role in a recall?

FDA has no authority under the FD&C Act to order a recall of a cosmetic, although it can request that a firm recall a product. However, we do have an active role in recalls. For example:

We monitor the progress of a recall [21 CFR 7.53]. In addition to reviewing firm status reports, we may conduct our own audit checks at wholesale or retail customers to verify the recall's effectiveness.
	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 a product under recall [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.
	If we believe that public notification is necessary, we assure that either FDA or the firm issues the public notification [21 CFR 7.42(b)(2)]. If the firm is unwilling to issue a press release, or unduly delays issuing a press release, we will issue one. FDA also issues general information about recalls through a weekly publication, the FDA Enforcement Report [21 CFR 7.50], which provides information on all recalls that have been assigned a classification.
	If we request a recall, we develop a recommended strategy for each recall that sets forth how the Agency expects it to be carried out and the necessity for any press release. If the firm develops a recall strategy, we review and comment on that strategy [21 CFR 7.42(a)(2)].
	We make sure that the product is destroyed or suitably reconditioned [21 CFR 7.55].back to top

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

Under the guidelines in 21 CFR Part 7, you are expected to do the following:

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 district office [21 CFR 7.46(d)].
	You should submit periodic recall status reports to the appropriate FDA district office so that we may assess the progress of the recall [21 CFR 7.53]
	If FDA or your firm determines that a public warning is necessary, you should submit such a statement and plan for its distribution to 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 are responsible for the disposition of the recalled product, whether the product is destroyed or brought into compliance [21 CFR 7.55].back to top

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 damage by being prepared in advance. The following are some tips:

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 need to incorporate into this plan [21 CFR. 7.59(a)].
	Assign production lot or batch numbers. 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. If the products do not have lot numbers, it may be necessary to recall all product on the market, since it will most likely be impossible to identify the specific production runs involved [21 CFR 7.59(b)].
	Maintain adequate distribution records to facilitate location of products being recalled. Maintain them for a period of time exceeding the shelf life and expected use of the product [21 CFR 7.59(c)].back to top

What should a cosmetic firm do to prevent similar problems?

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 FDA's Investigations Operations Manual, Chapter 8 (PDF 2.26 MB). To learn more about FDA's policies and procedures regarding recalls, you may check FDA's Regulatory Procedures Manual, Chapter 7, "Recall Procedures."

More Resources

FDA Authority Over Cosmetics
	Guidance & Regulations
	How FDA Evaluates Regulated Products: Cosmetics
	Key Legal Concepts: Interstate Commerce, Adulterated, and Misbranded
	Cosmetics Recalls and Alerts
	Enforcement Reports
	Report a ProblemUpdated July 29, 2002. This document is current. It is updated only as needed.

back to top

                                                                                  Content current as of:
      03/03/2022
              
              
Regulated Product(s)
		 CosmeticsCosmetics Recalls & Alerts
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop