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          Product Recalls, Including Removals and CorrectionsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Product Recalls, Including Removals and Corrections
					Guidance for Industry
		
		March 2020


	Download the  Final Guidance Document 

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		    Guidance Issuing Office
          Center for Devices and Radiological Health
          Center for Biologics Evaluation and Research
          Center for Drug Evaluation and Research
          Center for Food Safety and Applied Nutrition
          Center for Tobacco Products
          Center for Veterinary Medicine


This guidance document is intended to provide guidance and recommendations to FDA-regulated industry regarding what information firms should give to the Food and Drug Administration (FDA) and how they should notify their customers about product recalls. This guidance is intended to assist those members of industry regulated by the FDA in handling most aspects of a product recall, as well as some removals and corrections which do not meet the definition of a recall under 21 CFR 7.3. The guidance includes a checklist of documentation and information that industry can provide to the FDA that will be used by FDA to evaluate, classify, monitor and audit product recalls. Various statutory provisions and regulations, described below, authorize the FDA to require recalls of certain products in particular circumstances. Additionally, subpart C of part 7 of FDA regulations (21 CFR 7.40-59) provides general guidance for the voluntary recall of products, including those recalls initiated by a firm on its own and at the FDA's request. This guidance provides more specific recommendations and applies to voluntary and, to the extent that the guidance does not conflict with statute or regulation, mandatory recalls of all FDA-regulated products (i.e., food, including animal food; drugs, including animal drugs; medical and radiological devices and products; cosmetics; tobacco products; and biological products.)


 
	Submit Comments
	   		  			  			Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
						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 comments should be identified with the title of the guidance.

                                                                                  Content current as of:
      03/02/2020
         
                  
Regulated Product(s)
		 Animal & Veterinary
			  			     			  			     Biologics
			     			  			     Cosmetics
			     			  			     Dietary Supplements
			     			  			     Drugs
			     			  			     Food & Beverages
			     			  			     Medical Devices
			     			  			     Radiation-Emitting Products
			     			  			     TobaccoTopic(s)
			  RecallsSearch for FDA Guidance Documents

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