Contains Nonbinding Recommendations 
Questions and Answers Regarding 
Mandatory Food Recalls: Guidance for 
Industry and FDA Staff
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to https://www.regulations.gov.  Submit written comments to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.  All comments should be identified with the docket number 
FDA-2015-D-0138 listed in the notice of availability that publishes in the Federal Register.  
For questions or information regarding this guidance, contact the Office of Regulatory 
Affairs (ORA), Office of Strategic Planning and Operational Policy (OSPOP), Food and 
Drug Administration at ORAPolicyStaffs@fda.hhs.gov.  
U.S. Department of Health and Human Services 
Food and Drug Administration  
Office of Regulatory Affairs 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
November 2018  Contains Nonbinding Recommendations 
Table of Contents 
 
 
 
I. Introduction .................................................................................... 3
   
II. Background ..................................................................................... 3
   
III. Questions and Answers .................................................................. 4
   
 
 
 
   
  2  Contains Nonbinding Recommendations 
Questions and Answers Regarding 
Mandatory Food Recalls: Guidance for 
1
Industry and FDA Staff  
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on this topic.  It does not establish any rights for any person and is not binding on the FDA or the 
public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
for this guidance as listed on the title page. 
 
 
I.  Introduction 
 
The purpose of this document is to provide guidance to industry and FDA staff on the 
implementation of the mandatory food recall provisions of section 423 of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C.  350l] , which was added by section 206 of 
the FDA Food Safety Modernization Act of 2011 (FSMA).  The guidance in this document is in 
the form of Questions and Answers and provides answers to common questions that might arise 
about these mandatory recall provisions and FDAs current thinking regarding their 
implementation. 
 
The FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required. 
 
II.  Background 
 
The FDAs mandatory food recall authority went into effect when FSMA was enacted on 
January 4, 2011.  Section 423 of the FD&C Act, as added by section 206 of FSMA, gives the 
FDA the authority to order a responsible party to recall an article of food where the FDA 
determines that there is a reasonable probability that the article of food (other than infant 
formula) is adulterated under section 402 of the FD&C Act [21 U.S.C.  342] or misbranded 
under section 403(w) of the FD&C Act [21 U.S.C.  343(w)] and that the use of or exposure to 
such article will cause serious adverse health consequences or death to humans or animals 
(SAHCODHA). 
                                                 
1 This guidance has been prepared by the Office of Regulatory Affairs in cooperation with the Center for Food 
Safety and Applied Nutrition and the Center for Veterinary Medicine at the U.S. Food and Drug Administration.  
  3  Contains Nonbinding Recommendations 
 
III.  Questions and Answers 
 
This list of Questions and Answers is intended to provide answers to common questions about 
the mandatory recall provisions in section 423 of the FD&C Act and the FDAs current thinking 
regarding their implementation. 
 
1.  Why is mandatory food recall authority important?  
 
Before FSMA was enacted, the FDA relied on responsible parties to voluntarily recall 
violative food products (except infant formula recalls which are described under section 
412 of the FD&C Act).  The FDA continues to rely on responsible parties to voluntarily 
recall violative food products; however, FSMAs mandatory recall authority allows the 
FDA to mandate a recall when a responsible party chooses not to conduct a voluntary 
recall when the criteria under section 423 of the FD&C Act are met.  The FDA can use its 
mandatory recall authority when the FDA determines that there is a reasonable 
probability that an article of food is adulterated under section 402 of the FD&C Act 
and/or misbranded under section 403(w) of the FD&C Act and where there is a 
reasonable probability that the use of or exposure to such food would cause 
SAHCODHA.  
 
2.  What foods are subject to the FDAs mandatory food recall authority? 
 
The articles of food that are subject to the FDAs mandatory recall authority are all 
articles of food (other than infant formula) that are manufactured, processed, packed, or 
held at a food facility that is required to register under section 415(a) of the FD&C Act.  
Infant formula is not covered under section 423 because it has its own recall requirements 
under section 412 of the FD&C Act. 
 
The term food refers to (1) articles used for food or drink for man or other animals, (2) 
chewing gum, and (3) articles used for components of any such article (section 201(f) of 
the FD&C Act [21 U.S.C.  321(f)]).     
 
The term food includes dietary supplements, which are deemed to be food under the 
FD&C Act (section 201(ff) of the FD&C Act [21 U.S.C.  321(ff)]).  The term dietary 
supplement refers, with certain exceptions, to a product that is labeled as a dietary 
supplement, is intended for ingestion, is intended to supplement the diet, and contains at 
least one dietary ingredient.  Dietary ingredient(s) in these products include: vitamins, 
minerals, herbs or other botanicals, amino acids, and substances for use by man to 
supplement the diet by increasing total dietary intake.  Dietary ingredients can also be 
extracts, metabolites, constituents, concentrates, or a combination of any of the above-
mentioned dietary ingredients.         
 
3.  What is a responsible party under section 423 of the FD&C Act? 
 
  4  Contains Nonbinding Recommendations 
The responsible party with respect to an article of food under section 423 of the FD&C 
Act is defined under section 417 of the FD&C Act.  Section 417(a)(1) defines the term 
responsible party as a person who submits the registration under section 415(a) of the 
FD&C Act [21 U.S.C.  350d(a)] for a food facility that is required to register under 
section 415(a), at which such article of food is manufactured, processed, packed, or held.  
Person is defined in section 201(e) of the FD&C Act [21 U.S.C.  321(e)] as including 
individuals, partnerships, corporations and associations.  As such, the owner, operator, or 
agent in charge of a facility who is responsible for submitting the registration is also 
responsible for implementing and assuring the recall is performed, if so ordered under 
section 423 of the FD&C Act. 
 
4.  What are the criteria for a mandatory recall?  
 
Before the FDA can use its mandatory recall authority under section 423 of the FD&C 
Act, the FDA must make the determination that there is a reasonable probability that the 
article of food (other than infant formula) is adulterated under section 402 of the FD&C 
Act or misbranded under section 403(w) of the FD&C Act.  The FDA must also make a 
determination that there is a reasonable probability that the use of or exposure to such 
food will cause SAHCODHA. 
 
5.  What process will FDA follow for a mandatory recall? 
 
Once the FDA has determined that the criteria for a mandatory recall have been met, the 
FDA must first provide the responsible party (as defined in section 417(a)(1) of the 
FD&C Act) with an opportunity to voluntarily cease distribution and recall the article of 
food.  The FDA will notify the responsible party of this opportunity in writing using an 
expeditious method of delivery. If the responsible party refuses or does not voluntarily 
cease distribution and recall the article of food within the time and manner prescribed by 
the FDA, if so prescribed, the FDA may order the responsible party to cease distributing 
the article of food, order the responsible party to give notice to certain other persons to 
cease distributing the article of food, and give the responsible party an opportunity to 
request an informal hearing2 to be held not later than 2 days after the issuance of the 
order.    
 
After these steps are completed, the FDA may order a recall under section 423(d) of the 
FD&C Act if it is determined that the removal of the article from commerce is necessary.  
Only the FDA Commissioner has the authority to order a recall under section 423(d).  If 
necessary, recall orders under section 423(d) shall be vacated by the Commissioner.  
 
If the FDA orders a recall under section 423 of the FD&C Act, the FDA will generally 
follow the process for termination of the recall in accordance with 21 C.F.R. 7.55. 
 
6.  When is a food considered adulterated under section 402 of the FD&C Act? 
                                                 
2 The informal hearing will be conducted in accordance with the procedures in 21 C.F.R. Part 16, Regulatory 
Hearing Before the Food and Drug Administration, to the extent that such procedures are not in conflict with section 
423 of the FD&C Act. 
  5  Contains Nonbinding Recommendations 
 
There are many reasons a food may be adulterated under section 402 of the FD&C Act 
including, but not limited to: 
  If the food bears or contains any poisonous or deleterious substance which 
may render it injurious to health; consists in whole or in part of any filthy, 
putrid, or decomposed substance, or is otherwise unfit for food; or has been 
prepared, packed, or held under insanitary conditions whereby it may have 
become contaminated with filth, or whereby it may have been rendered 
injurious to health; 
  If the food is a dietary supplement or contains a dietary ingredient that 
presents a significant or unreasonable risk of illness or injury under the 
conditions of use recommended or suggested in labeling; is a new dietary 
ingredient for which there is inadequate information to provide reasonable 
assurance that such ingredient does not present a significant or unreasonable 
risk of illness or injury; or is a dietary supplement declared by the Secretary to 
pose an imminent hazard to public health or safety. 
 
7.  When is a food considered misbranded under section 403(w) of the FD&C Act? 
 
Section 403(w) refers to product labeling required to be present if a food, other than a 
raw agricultural commodity, bears or contains a major food allergen.  Major food 
allergens are defined at section 201(qq) of the FD&C Act [21 U.S.C.  321(qq)] as milk, 
egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and any food 
ingredients that contain a protein derived from these foods (with limited exceptions noted 
under section 201(qq)(2)).  Under section 403(w), a food, other than a raw agricultural 
commodity, is misbranded if it bears or contains a major food allergen and the label for 
the food does not identify the name of the food source from which the major food 
allergen is derived, either through a Contains statement or in the ingredient list, as 
specified under section 403(w). 
 
8.  What evidence or circumstances might the FDA consider when deciding to move 
forward with a mandatory food recall under section 423? 
 
The FDA will evaluate all applicable evidence, when determining whether there is a 
reasonable probability the article of food (other than infant formula) is adulterated under 
section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act and 
that the use of or exposure to such article will cause SAHCODHA.  These circumstances 
or evidence may include:  
  Significant food safety observations made during establishment inspections; 
  Results from sample analyses, which may include those for raw materials or 
finished food products, and certain sample swabs from the food facility 
manufacturing environment; 
  Epidemiological data (e.g., food borne outbreak data directly related to the food 
product that suggest disease or injuries have already occurred from the 
consumption of/exposure to the product); 
  6  Contains Nonbinding Recommendations 
  Vulnerability of the population that normally consumes or is exposed to the food 
product (the assessment of the hazard will take into account the segment of the 
population, e.g., infants, toddlers, the elderly, pregnant women, medically-
compromised individuals, certain pets, young livestock); 
  Nature of the food product (e.g., Ready-to-eat food3, raw, cooked); 
  Reportable Food Registry data;  
  Consumer and trade complaints; and 
  Whether the responsible party has failed to initiate a voluntary recall. 
 
9.  What are some examples or situations when the FDA would deem a food product to 
represent a SAHCODHA risk? 
 
Examples of situations generally representing a SAHCODHA risk include, but are not 
limited to, Listeria monocytogenes (Lm) or Salmonella spp. in Ready-to-eat foods, certain 
undeclared allergens in food products, E. coli O157:H7 in leafy greens, and botulinum 
toxin found in food products.  Some past Class I food recalls representing this risk have 
included: 
 
  Peanut butter, alfalfa sprouts, and deli products found to be contaminated with 
Salmonella spp.; 
  Under-processed canned chili that contained Clostridium botulinum toxin; 
  Smoked salmon and pumpkin seeds found to be contaminated with Lm.; 
  Products containing undeclared allergens (e.g., milk, peanuts, or eggs); 
  Baby food that posed a choking hazard; 
  Horse feed contaminated with elevated levels of monensin; 
  Pet foods contaminated with elevated levels of melamine and cyanuric acid, or 
contaminated with Salmonella spp. or Lm.; 
  Sheep feed containing elevated levels of copper. 
 
10.  How will the FDA publicize information about the mandatory recall?   
 
In accordance with section 423(g) of the FD&C Act, the FDA will ensure that a press 
release is published regarding the recall, as well as alerts and public notices, as 
appropriate, to provide notification to affected consumers and retailers.  The publication 
will include, at a minimum, the name of the article of food subject to recall, a description 
of the risks associated with the food, and to the extent practical, information about similar 
articles of food that are not affected by the recall. 
                                                 
3 Per 21 C.F.R. 117.3, Ready-to-eat food (RTE food) means any food that is normally eaten in its raw state or any 
other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without 
further processing that would significantly minimize biological hazards. 
  7