Public Warning and 
Notification of Recalls Under  
21 CFR Part 7, Subpart C 
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-2016-
D-3548. 
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.  
 
The draft of this guidance was issued in January 2018. 
 
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 Drug Evaluation and Research 
Center for Biologics Evaluation and Research 
Center for Devices and Radiological Health 
Center for Veterinary Medicine 
Center for Tobacco Products 
 
 
FEBRUARY 2019 
 
 
 
   Contains Nonbinding Recommendations 
Public Warning and 
 
Notification of Recalls Under  
21 CFR Part 7, Subpart C 
 
Guidance for Industry and FDA Staff 
 
 
Additional copies are available from: 
Office of Strategic Planning and Operational Policy  
Office of Regulatory Affairs,  
Food and Drug Administration 
 12420 Parklawn Drive, Element Building,  
Rockville, MD 20857 
 
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 Drug Evaluation and Research 
Center for Biologics Evaluation and Research 
Center for Devices and Radiological Health 
Center for Veterinary Medicine 
Center for Tobacco Products 
 
FEBRUARY 2019 
Recalls 
 
 
 
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   Contains Nonbinding Recommendations 
 
 
Table of Contents 
 
I. INTRODUCTION ..................................................................................................................... 4 
II. TERMINOLOGY .................................................................................................................... 5 
III. DISCUSSION ......................................................................................................................... 6 
A.  Public Warnings ............................................................................................................. 6 
1.  Under what circumstances should firms issue public warnings?................................. 6 
2.  Who prepares public warnings? ................................................................................... 8 
3.  What information should be contained in a public warning? ...................................... 9 
4.  How are public warnings distributed and displayed? ................................................ 10 
B.  Public Notification of Recalls ...................................................................................... 11 
IV. REFERENCES ..................................................................................................................... 11 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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   Contains Nonbinding Recommendations 
Public Warning and Notification of 
Recalls Under  
21 CFR Part 7, Subpart C 
Guidance for Industry and FDA Staff 
 
 
This guidance represent the current thinking of the U.S. Food and Drug Administration (FDA, 
 we, or Agency) 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 guidance is to assist and provide recommendations to industry and FDA staff 
regarding the use, content, and circumstances for issuance of public warnings and public 
notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C  
Recalls (Including Product Corrections) Guidance on Policy, Procedures, and Industry 
Responsibilities.  The guidance also discusses what information should be included in a public 
warning, as well as the parties responsible for issuing it.  It represents FDAs current thinking on 
public warning and notification of recalls under 21 CFR Part 7.   
This guidance applies to voluntary recalls of products subject to FDAs jurisdiction, including 
any food, drug, and device intended for human or animal use, any cosmetic and biologic 
intended for human use, any tobacco product intended for human use, and any item subject to a 
quarantine regulation under 21 CFR Part 1240.  However, it does not apply to radiation emitting 
electronic products which are governed only by 21 CFR Parts 1003 and 1004.   
FDA's guidance documents do not establish legally enforceable responsibilities. Instead, 
guidance describes 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 guidance means that something is suggested or recommended, but not 
required. 
 
 
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II. Terminology: 
Recall 
Recall means a firms removal or correction of a marketed product that FDA considers to be in 
violation of the laws it administers and against which the Agency would initiate legal action, 
e.g., seizure.  Recall does not include a market withdrawal or a stock recovery.1 (21 CFR 
7.3(g)) 
Recall Determination  
A recall determination is the assessment the FDA makes in deciding that a firms ongoing or 
completed removal or correction of a marketed violative product constitutes a recall as defined at 
21 CFR  7.3(g). A firms characterization of its action is not determinative of whether the FDA 
would determine that the action is a recall.  A firms action constitutes a recall when it meets the 
definition of recall under 21 CFR  7.3(g).  
Recall Classification 
Recall classification means the numerical designation, i.e., I, II, or III, assigned by the FDA to a 
particular product recall to indicate the relative degree of health hazard presented by the product 
being recalled or considered for recall.  (21 CFR  7.3(m), 7.41(b)). The determination is made 
on the basis of the health hazard evaluation and in consideration of the factors provided at 21 
CFR  7.41.  
Public Warning 
The purpose of a public warning under 21 CFR Part 7 is to alert the public that a product being 
recalled presents a serious health hazard.  It is reserved for urgent situations where other means 
of preventing use of the recalled product appear inadequate.  (21 CFR  7.42(b)(2)).2  Public 
warnings under 21 CFR Part 7 can be disseminated through general or specialized news media, 
e.g., professional or trade press, and/or to specific segments of the population such as physicians, 
hospitals, etc.  The FDA may issue public warnings in a variety of forms, including, but not 
limited to, press releases, emails, and web and social media postings.  
Public Notification of Recalls 
The FDA promptly makes available to the public in the weekly FDA Enforcement Report a 
descriptive listing of each new recall according to its classification, whether it was FDA-
requested or firm-initiated, and the specific action being taken by the recalling firm.  (21 CFR  
                                                 
1 21 CFR  7.3(j) defines market withdrawal to mean a firm's removal or correction of a distributed product which 
involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which 
involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.  Stock 
recovery means a firm's removal or correction of a product that has not been marketed or that has not left the direct 
control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion 
of the lot has been released for sale or use.  21 CFR  7.3(k). 
2 In addition to the public warning authority described in 21 CFR Part 7, the Agency has other authorities to 
disseminate information in an array of circumstances, for example, the Secretarys authority in 21 U.S.C. 375(b) to 
disseminate information about FDA regulated products in situations that the Secretary determines involve imminent 
danger to health or gross deception of the consumer .  Nothing in this guidance is meant to define, shape, or limit 
those authorities in any way.  
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7.50).   
Confidential Commercial Information (CCI) 
Commercial or financial information that is privileged or confidential means valuable data or 
information which is used in one's business and is of a type customarily held in strict confidence 
or regarded as privileged and not disclosed to any member of the public by the person to whom it 
belongs. (21 CFR  20.61(b)).  
 
III. Discussion:  
The FDAs policy is to evaluate the particular circumstances of each individual recall in 
determining whether a public warning is needed in accordance with 21 CFR  7.42(b)(2) as part 
of the recall strategy.  The FDA may issue a public warning or notification before formally 
classifying a recall under 21 CFR  7.41(b).  We note that due to the level of hazard associated 
with Class I recalls, the FDA has generally issued, and/or sought issuance of, public warnings in 
Class I or potential Class I recalls unless specific circumstances indicate that one would not be 
beneficial to the public.  The FDA also recommends and/or issues public warnings for some 
urgent Class II recalls that, while not rising to Class I hazards, still present a serious hazard to 
health.3  
Once the FDA makes a recall determination or classification, the recall will be listed in the 
weekly FDA Enforcement Report in accordance with 21 CFR 7.50.   
 
A.  Public Warnings  
 
1.  Under what circumstances should firms issue public warnings? 
Public warnings are for urgent situations and are issued to alert the public that a product being 
recalled presents a serious hazard to health, and where other means for preventing the use of a 
recalled product appear inadequate.  For instance, public warnings may be appropriate for urgent 
recalls of prescription drugs or medical devices when retail level consignees cannot identify 
persons to whom the drug or device was dispensed.  A public warning is also often needed when 
a recalled product has been widely distributed.   
On the other hand, when recalled products have only been distributed to direct accounts4, and the 
recalling firm has records that show exactly where the products have gone, a prompt and 
effective communication to such accounts informing them of the recall may be adequate to 
                                                 
3 FDA has recommended public warnings for Class II recalls involving, for example, foods with low levels of 
undeclared allergens (e.g., wheat).  While the adverse health consequences may be remote or temporary, FDA is 
committed to acting immediately when necessary to protect the public health. 
4 For internet purchases, the consumer level is considered a direct account.  For some internet purchases, prompt and 
effective communication may not be feasible, and thus distribution to the direct account in an internet transaction 
may warrant a public warning.  Where communication is feasible, the internet seller should attempt to confirm 
receipt of the communication.  
 
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prevent the use of a recalled product.5 This could be an instance where the product has only 
reached the wholesale level, such as a warehouse or distribution center, and has not been further 
distributed to the retail or consumer level.   
The FDA generally recommends public warning for recalls that are likely to be classified as, or 
have been classified as Class I recalls, unless specific circumstances indicate that the warning 
would not be beneficial to the public. Such circumstances could be where there is not adequate 
information to convey risk and appropriate actions, or when the product is limited to a small 
number of consignees that are easily identified and can be rapidly reached through targeted 
contact. Furthermore, different products might dictate different communication considerations.  
For instance, during a medical device recall, the FDA may consider how patients respond to a 
public warning about a defective product without first having the benefit of consulting with their 
physician.  In these and similar situations, public warnings may be more confusing than helpful. 
The FDA will continue to assess the need for public warnings for voluntary recalls of FDA-
regulated products based on the particular circumstances of the individual recall.  The following 
recalls generally present examples of serious hazards to health such that a public warning may be 
warranted: 
  Recalls of food products initiated by a firm after receipt of consumer reports of illness 
or injury (including allergic reactions), for which there is an active outbreak 
associated with the product or its ingredients, or for which the FDA has substantiated 
reports of illness or injury.  
  Recalls of food products that are intended for or would more likely be consumed by 
vulnerable populations.  Examples of vulnerable human populations include infants, 
toddlers, the elderly, pregnant women, and medically-compromised individuals, who 
may be more susceptible to foodborne hazards than healthy persons. 
 
  Recalls of food products initiated because of manufacturing deviations where the 
consequences of the manufacturing deviations could have significant health impacts; 
e.g., under processed low-acid canned foods which could result in botulism if the 
product is consumed. 
  Recalls of food products initiated because of microbiological pathogen findings (e.g., 
Listeria monocytogenes, Salmonella, etc.) in environmental testing where direct food 
manufacturing contact surfaces are found to be contaminated. 
 
  Recalls of animal food products which may be contaminated with low levels of drugs 
or unsafe food additives. Examples include pet jerky treats contaminated with 
antibiotics, and cat food products containing propylene glycol.  
 
  Recalls of home use medical devices which could malfunction and lead to incorrect 
dosing of drugs or blood volumes.  
                                                 
5 To be adequate to prevent the use of the product, a recalling firm should be able to confirm that business accounts 
received the communication and understood the instructions conveyed in the communication.  FDAs model recall 
return response form, available in FDAs Regulatory Procedures Manual, is one way a recalling firm can document 
such confirmation from business accounts.  
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  Recalls of sterile injectable drug products which may contain particulate matter. 
 
  Recalls of implantable pacemakers or defibrillators where the devices battery may 
fail suddenly and without warning. 
 
The FDA may issue or supplement a firms public warning, among other actions, in the 
following situations: a firm refuses to issue its own public warning when recommended or 
requested by the FDA, an ongoing recall or public warning is not prompt or effective, or the 
FDA learns of a completed recall where new adverse events associated with the product are 
reported after completion of the recall. The FDA will generally provide a timeframe for when the 
firm should issue a public warning based on the circumstances of the individual recall.  While 
timeframes will vary depending on the recall and product, these firms should generally issue a 
public warning within 24 hours of the FDA notifying the firm that it believes a public warning is 
appropriate.  
 
2.  Who prepares public warnings? 
The FDA generally gives firms the first opportunity to prepare and issue public warnings during 
recalls. For instance, for firm-initiated recalls, recalling firms are expected to develop their own 
recall strategy. The recall strategy addresses, among other things, whether a public warning is 
needed and how it will be issued.  In most cases, the FDA reviews and comments on the recall 
strategies, including any public warnings developed by firms (see 21 CFR  7.42(b)(2)). Firms 
should include any drafted public warning as part of their submission of the recall strategy to the 
extent that it does not delay strategy development or recall initiation.6  In other situations that 
warrant an immediate warning, firms may choose to issue public warnings without the FDAs 
review.  The FDA may supplement that warning with its own public statement, if necessary.  
When the FDA believes that a public warning is appropriate and the recalling firm does not 
include one in its initial recall strategy, the FDA will generally request one from the recalling 
firm.   
In some situations, the FDA may prepare and issue public warnings on its own initiative and in 
accordance with 21 CFR  7.42(b)(2).  This may occur, for instance, when the public needs 
immediate warning concerning a product and the firm has not issued a public warning or a firms 
public warning is deficient. The FDA will ordinarily work with the recalling firm to ensure the 
factual accuracy of a public warning. However, the FDA is not required to contact the firm 
before issuing a public warning or allow its review of the proposed statement.  
If a firm issues a public warning that is deficient in any respect (see also section III.A.3 in this 
document), the FDA may supplement or correct that warning with its own public warning. If a 
firms public warning is not reasonably likely to be adequately received by the target audience, 
the FDA may ask the firm to reissue its public warning and/or the FDA may issue its own public 
warning.  Additionally, the FDA may publicly issue information that may address outstanding 
questions about the nature of the incident and/or the Agencys actions.  
                                                 
6 Firms are reminded that, under 21 CFR  7.42, they need not delay the initiation of a recall pending the FDAs 
review of their recall strategy. 
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3.  What information should be contained in a public warning? 
The purpose of a public warning is to alert the public that a product being recalled presents a 
serious hazard to health. As such, a public warning should include: a) information to help 
identify the recalled product including images, numerical product information (e.g., lot number, 
expiration date, serial number, unique device identification (UDI) number), packaging 
information or brand names; b) the geographic areas and dates of distribution of the affected 
product; c) a thorough description of the product defect, health hazard involved, and reason(s) 
for recall (e.g., product testing, environmental sampling, etc.); d) the name and contact 
information for the recalling firm; e) instructions to consumers or users; f) the number and nature 
of any illnesses/injuries/complaints associated with the product, related to the product defect; and 
g) a description of common symptoms of any illness of concern. The headline of the public 
warning should include the brand name, type of product, and the hazard prompting the recall 
(e.g., XYZ chocolate chip cookies recalled for potential Salmonella contamination.).   
In some cases, it may also be necessary to include the recalling firms supply-chain relationships 
in order to alert the public of the product being recalled. When possible, the FDA encourages 
firms to provide specifics about firms it sold product to in order to help people better identify and 
avoid recalled product.7    
What should not be included 
Public warnings should not contain content that detracts from or defeats the purpose of the 
warning.  Brief and succinct warnings are generally better at informing consumers of a product 
hazard and helping consumers understand the importance of avoiding the product. On the other 
hand, messages that cloud or lengthen a warning may distract a consumer and should be avoided.  
Generally, firms should not promote the qualities of the product being recalled, other products 
sold by the firm, or the firm in general, as part of a public warning. Phrases such as an 
abundance of caution, that can be seen as trying to minimize the hazard, should not be used, for 
example, when illnesses or injury have resulted, or when there are positive results for pathogens 
associated with the finished product or ingredients. 
What might make a public warning deficient 
A public warning may be considered deficient if, among other things, it does not adequately 
identify the recalled product, describe the health hazard involved, or identify relevant 
information about the products distribution.  A public warning might also be considered 
deficient if, on the basis of the FDAs media monitoring, it is determined that the warning did 
not sufficiently reach the target audience (e.g., the firms release was not disseminated 
sufficiently by the news media; the firms warning for a nationally-distributed product was 
issued only to a regional audience; no Spanish translation was made available for a product 
largely used by Spanish-speaking populations).  A factual statement in a firms public warning 
that the FDA is unable to verify might also cause the FDA to issue a separate public warning.  
                                                 
7 FDAs recall communications are intended to be as informative as possible within the scope of the Agencys 
authority for information disclosure.  For example, depending on the circumstances, certain information such as 
supply-chain relationships and product distribution data may be CCI, which is generally protected from public 
disclosure.  FDAs regulations authorize the release of CCI, in relevant part, when necessary to effectuate a recall. 
(21 CFR  20.91). 
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The FDA will take actions to correct or supplement deficient public warnings as described in this 
guidance.  The Agency encourages firms issuing public warnings to monitor media coverage and 
take further action to raise public awareness if media coverage appears to be insufficient. 
 
4.  How are public warnings distributed and displayed? 
 
Firms and the FDA can alert the public about a recall by various means, including issuing press 
releases to the media, sending emails to a listserv or subscription service, and posting on the 
FDA and company websites or social media.  All of these methods could be used to issue a 
public warning. 
 
Issuing the Public Warning through a Press Release 
It is critical that public warnings are distributed in a way that ensures that the information 
conveyed in the warning actually reaches the public. To this end, the FDA is open to different 
vehicles of dissemination that best convey the information of the particular recall.  Historically, 
the FDA and industry have used general news media, as well as specialized news media, e.g., 
professional or trade press, among other means.  When warranted, the FDA recommends that 
firms use press release distribution services or other mechanisms that ensurethe information in 
the press release will be appropriately relayed to the public, e.g., through news media outlets.  
Part of a firms responsibility to inform a consumer of a recalled product includes taking earnest 
efforts to ensure that the information is actually distributed. 
Firms issuing public warnings through press releases should also consider the area of distribution 
of the recalled product.  The distribution of the release should match the distribution of the 
product: if the product is available online or is distributed nationally, the public warning should 
also be available online and/or distributed nationwide.  Similarly, if the product is only available 
in a regional market, and the FDA and the firm are confident that no consumers from outside that 
region may have received it, the distribution of the public notification may be similarly targeted.  
If it is apparent that a significant percentage of consumers using the recalled product speak a 
language other than English, firms should consider having the public warning translated into that 
language and distributed via the appropriate distribution service. 
Posting a Public Warning or Press Release on a firm or FDA Webpage 
In many cases, a firm will announce a removal of an FDA regulated product from the market or 
correction8 through a press release or other public announcement prior to the FDA reviewing and 
determining the action to be a recall.  The FDA may post the information in or the text of the 
announcement on FDA.gov/recalls9 if the FDA believes the announcement is factually correct 
and beneficial to consumers.   
The FDA does not typically post a firms announcement of an action that the FDA believes will 
                                                 
8 A correction is a repair, modification, adjustment, relabeling, destruction or inspection (including patient 
monitoring) of a product without its physical removal to some other location. 21 CFR  7.3(h). 
9 This webpage also provides links to various FDA Center webpages, where public warnings of recalls of products 
specific to that Center are also posted. 
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not be considered a recall. Further, not all recalls are posted on the FDA.gov/recalls page since 
not all recalls warrant a public warning and not all firms will issue a press release, depending on 
the circumstances. When the FDA posts removal or correction information that has been 
publicized by a firm, we do so as a public service and it does not necessarily mean that the 
situation is urgent or that the product presents a serious hazard to health, such that it would be 
considered a public warning as the term is defined in this guidance document.  Information on 
major product recalls that the FDA believes merit expanded coverage due to the impact they 
have on public health can be found at 
https://www.fda.gov/Safety/Recalls/MajorProductRecalls/default.htm.  When a firm posts its 
public warning on its own webpage, it should ensure that the warning is prominently displayed 
and accessible from both its home page and a web search.  The posting should remain publicly 
accessible until the product is no longer expected to be used or consumed.   
 
B.  Public Notification of Recalls 
The FDA provides public access to information on recalls by posting a listing of recalls 
according to their classification in the FDA Enforcement Report, whether they were requested by 
FDA or firm-initiated, and the specific action taken by the recalling firm.10 The FDA 
Enforcement Report is designed to provide a public listing of products in the marketplace that 
are being recalled.  Unlike with public warnings, the recalls listed in the FDA Enforcement 
Report are not limited to urgent situations that present serious hazards to health and are not 
necessarily used to alert the public about the risk or hazard of a product under recall.   
Information on all recalls will be provided in the FDA Enforcement Report, regardless of the 
level of the hazard.  The FDA will attempt to promptly post public notifications; however, delays 
might occur due to the timeliness of a firms recall submission, the availability of facts, and other 
factors outside the FDAs control. The FDA may consider delaying public notification if it may 
cause unnecessary and harmful anxiety in certain consumers (e.g., when a patient needs to hear 
first from his doctor about a defective implanted medical device). The FDA is not required to 
provide firms with an opportunity to review and comment on public notifications, but may 
consult with a firm to ensure factual accuracy or when otherwise warranted.  
Public notifications of recalls will only be posted in the FDA Enforcement Report after the FDA 
makes a determination that the action is a recall under 21 CFR  7.3(g).  If the recall posted in 
the FDA Enforcement Report has not yet been classified, the FDA will document the recall as 
not yet classified.11  
IV. References 
1.  U.S. Food and Drug Administration.  Guidance for Industry: Product Recalls, Including 
Removals and Corrections. Last updated 08/22/2014.  
https://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm 
 
                                                 
10 We note that, although they are not the subject of this guidance document, mandatory recalls are also listed in the 
FDA Enforcement Report.  
11 FDA has begun posting information relating to some voluntary recalls when this information is provided to the 
agency, prior to the review and possible classification. 
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2.  U.S. Food and Drug Administration.  Recalls, Market Withdrawals, & Safety Alerts. 
Last updated 04/04/2017.  
https://www.fda.gov/Safety/Recalls/default.htm 
 
3.  U.S. Food and Drug Administration.  Industry Guidance for Recalls. Information on 
Recalls of FDA Regulated Products. Last updated 08/15/2014.  
http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm 
 
4.  U.S. Food and Drug Administration. Recalls, Corrections and Removals (Devices). Last 
updated 01/03/2017.  
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequire
ments/RecallsCorrectionsAndRemovals/default.htm 
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