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:

                Search for FDA Guidance Documents

Search for FDA Guidance Documents

                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents Home
          Regulatory Information
          Search for FDA Guidance Documents
          Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart CSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C
					Guidance for Industry and FDA Staff
		
		March 2022


	Download the  Final Guidance Document 

    Final

	  
	  
	Share
    Post
    Linkedin

    Email
    PrintDocket Number:
		    FDA-2018-D-2074
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine
          Office of Regulatory Affairs
          Center for Food Safety and Applied Nutrition
          Center for Biologics Evaluation and Research
          Center for Devices and Radiological Health
          Center for Drug Evaluation and Research
          Center for Tobacco Products


The purpose of this guidance is to clarify FDA’s recommendations for industry and Agency staff regarding timely initiation of voluntary recalls under 21 CFR part 7, subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities.  The guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices.  It also discusses preparations firms in the distribution chain should consider making to ensure timely responses to a recall communication.  Additionally, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA.


 
	Submit Comments
	   		  			    		Submit Comments Online
					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2018-D-2074.



  
	Questions?
	
  Contact Point
          ORA Office of Strategic Planning and Operational Policy (OSPOP)
				    		    	
		    		    	Contact for guidance document questions
		ORAPolicyStaffs@fda.hhs.gov

                                                                                  Content current as of:
      03/10/2022
         
                  
Topic(s)
			  Recalls
				    				       				    				       Investigation & EnforcementSearch for FDA Guidance Documents

        Search for FDA Guidance Documents

          
                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents
 
 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