Contains Nonbinding Recommendations 
 
Initiation of Voluntary 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-2018-
D-2074. 
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 April 2019. 
 
 
U.S. Department of Health and Human Services  
Food and Drug Administration 
Office of Regulatory Affairs  
Center for Biologics Evaluation and Research 
Center for Drug Evaluation and Research 
Center for Devices and Radiological Health 
Center for Food Safety and Applied Nutrition 
Center for Tobacco Products 
Center for Veterinary Medicine 
 
March 2022 
    Contains Nonbinding Recommendations 
 
Initiation of Voluntary 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 Biologics Evaluation and Research 
Center for Drug Evaluation and Research 
Center for Devices and Radiological Health 
Center for Food Safety and Applied Nutrition 
Center for Tobacco Products 
Center for Veterinary Medicine 
 
March 2022 
Recalls 
    Contains Nonbinding Recommendations 
 
Table of Contents 
I. INTRODUCTION ....................................................................................................................... 1 
II. TERMINOLOGY....................................................................................................................... 2 
III. DISCUSSION ........................................................................................................................... 3 
A.  HOW SHOULD A FIRM IN A PRODUCT DISTRIBUTION CHAIN PREPARE TO FACILITATE 
TIMELY INITIATION OF A VOLUNTARY RECALL? ............................................................. 3 
1.  GENERAL PREPARATIONS ............................................................................................ 3 
2.  RECOMMENDED PROCEDURES FOR INITIATING A RECALL AND PERFORMING 
ACTIONS RELATED TO INITIATING A RECALL ............................................................. 5 
B.  WHAT SHOULD A FIRM DO IF THERE IS AN INDICATION OF A PROBLEM WITH A 
DISTRIBUTED PRODUCT? .................................................................................................. 7 
C.  HOW SHOULD A FIRM INITIATE A VOLUNTARY RECALL? ................................................ 9 
D.  HOW DOES FDA WORK WITH A RECALLING FIRM TO INITIATE A VOLUNTARY RECALL 
IN A TIMELY MANNER? ..................................................................................................... 9 
 
   Contains Nonbinding Recommendations 
Initiation of Voluntary Recalls Under 
21 CFR Part 7, Subpart C 
1
Guidance for Industry and FDA Staff  
This guidance represents 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 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 clarify FDAs 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.    
This guidance applies to voluntary recalls2 of products subject to FDAs jurisdiction, including 
any food, drug, and device intended for human or animal use, any cosmetic and biological 
product intended for human use, any tobacco product intended for human use, and any item 
subject to a quarantine regulation under 21 CFR part 1240.  This guidance applies to devices that 
are electronic products regulated as radiology devices subject to 21 CFR part 892.  It does not 
apply to electronic products subject to 21 CFR parts 1003 and 1004.   
1 This guidance has been prepared by the Office of Regulatory Affairs (ORA), in collaboration with the Center for 
Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for 
Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), the Center 
for Tobacco Products (CTP), and the Center for Veterinary Medicine (CVM) at the U.S. Food and Drug 
Administration. 
2 This guidance could also inform actions by manufacturers and distributors to remove or correct a marketed product 
under circumstances that would not meet the definition of a recall, e.g., a market withdrawal.  
1  Contains Nonbinding Recommendations 
FDAs 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 statutory or regulatory requirements are cited.  The use of the 
word should in Agency guidance means that something is suggested or recommended, but not 
required. 
 
II. TERMINOLOGY 
Consignee 
Consignee means anyone who received, purchased, or used the product being recalled. (21 CFR 
7.3(n)). 
Correction 
Correction means 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)). 
Direct Account 
Direct Account, for the purpose of this guidance, means the first consignee in a firms 
distribution chain. 
Initiation of a Recall 
Initiation of a recall, for the purpose of this guidance, means a recalling firms first 
communication about a recall, to its direct accounts or to the public.3 
Market Withdrawal 
Market withdrawal means a firms removal or correction of a distributed product which involves 
a minor violation that would not be subject to legal action by the FDA or which involves no 
violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. 
(21 CFR 7.3(j)). 
Recall  
Recall means a firms removal or correction of a marketed product that the 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. (21 CFR 7.3(g)). 
Recalling Firm 
Recalling firm means the firm that initiates a recall or, in the case of a FDA-requested recall, the 
firm that has primary responsibility for the manufacture and marketing of the product to be 
recalled. (21 CFR 7.3(i)). 
 
 
3 Initiating a recall in accordance with the provisions in 21 CFR part 7 does not negate any regulatory requirements 
that might be applicable with respect to the violative product (e.g., the requirement to report the initiation of a 
correction or removal in accordance with 21 CFR 806.10). 
2 
  Contains Nonbinding Recommendations 
III. DISCUSSION 
A.  HOW SHOULD A FIRM IN A PRODUCT DISTRIBUTION CHAIN PREPARE TO FACILITATE 
TIMELY INITIATION OF A VOLUNTARY RECALL? 
It is critical for firms in a product distribution chain to be recall ready.  FDA recommends that 
a firm make the following preparations as appropriate and applicable to its operations in advance 
of when a recall may be needed:4 
 
1.  GENERAL PREPARATIONS 
  Identify appropriate personnel.  Specific personnel should, and sometimes must,5 be 
assigned recall-related responsibilities and possess the authority to take the steps needed 
to implement a product recall when necessary.  The need for identification of alternate 
personnel should be considered.  When a firm anticipates that its recall efforts would be 
complex or have other complicating factors (e.g., a large or multi-layered distribution 
chain), the establishment of a recall team may be appropriate.  For example, a recalling 
firm could designate a team of employees that includes a recall coordinator and personnel 
with decision-making authority to initiate a product recall. 
 
  Train personnel on their responsibilities.  Personnel who have been identified to perform 
recall activities should be trained on a regular basis so they have a thorough 
understanding of the recall procedures they are being asked to perform.  A firm that 
anticipates complex recalls may want to consider additional preparatory steps, such as 
mock recalls, to verify the firms recall readiness.  Mock recalls familiarize personnel 
with the recall process and may improve the effectiveness of the firms recall program.  
The firm should also consider establishing metrics appropriate to its recall plan and 
consider taking actions to improve its recall plan, such as making modifications to 
procedures or training its personnel, if it is not satisfied with the results of a mock or 
actual recall. 
 
  Establish a recall communications plan.  Such a plan should address internal 
communications, communications with FDA, and communications to direct accounts or 
the public in the event that a recall is deemed necessary.  The firm should consider 
identifying specific points of contact for each of these types of communications ahead of 
time, and should maintain draft templates that help the firm issue recall communications 
promptly, e.g., notification letters to direct accounts and draft press releases.6  FDA 
encourages the use of electronic communications for conveying voluntary recall 
communications about FDA-regulated products.7   
 
4 Recall plans and initiation procedures should be specific to the firm or facility.  Firms should consider writing 
additional plans or procedures as appropriate to their business operations, e.g., to address a complex distribution 
chain. 
5 See, e.g., 21 CFR 507.38(a)(2) and 21 CFR 117.139(b). 
6 Model recall communications templates are available on the FDA website (visit 
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls). 
7 See FDAs guidance Using Electronic Means to Distribute Certain Product Information, which represents the 
current thinking of FDA on this topic.  We update guidances periodically.  For the most recent version of a 
 
3 
  Contains Nonbinding Recommendations 
 
  Identify any reporting requirements for distributed products.  Certain problems with a 
distributed product may trigger a requirement to make a report to FDA.  Examples of 
reporting requirements include but are not limited to: 
 
  A report to the Reportable Food Registry.8  
o
  An adverse event report for a dietary supplement.9  
o
  A Field Alert Report for a distributed human or animal drug product.10  
o
  A report of a product deviation associated with the manufacturing of certain 
o
biologics.11   
  A report in advance of a discontinuance or interruption in a firm or facilitys 
o
production of a life-saving drug that is likely to lead to a meaningful disruption in 
your own supply of that drug.12   
A firm may also be required to submit a report to FDA when it conducts a product 
correction or removal, e.g., the correction or removal of certain medical devices13 or 
when it recalls infant formula.14  A firm should know in advance whether its product is 
associated with any legal or regulatory requirements to make a report to FDA.   
 
  Use adequate product coding.  Certain products have specific product coding 
requirements.  Examples of product coding requirements include but are not limited to: 
 
  Many human prescription drug products must use a product identifier.15  
o
  Blood and blood components generally have container label requirements.16   
o
  Many medical devices must bear a unique device identifier (UDI) on their labels 
o
and device packages.17   
Whether required or not, firms should use sufficient coding of regulated products to make 
possible positive lot identification and to facilitate the effective recall of all violative lots.  
(21 CFR 7.59(b)).  The coding used should allow for identification of the production and 
 
guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents. 
8 See section 417 of the FD&C Act [21 U.S.C. 350f]. 
9 See section 761 of the FD&C Act [21 U.S.C. 379aa-1]. 
10 See 21 CFR 314.81(b)(1) (human drug regulation); 21 CFR 514.80(b)(1) (animal drug regulation). 
11 See 21 CFR 600.14; 21 CFR 606.171; see also 21 CFR 1271.350.  
12 See 80 FR 38915 and section 506C of the FD&C Act [21 U.S.C. 356c].  FDA requests that you immediately 
notify Drug Shortage Staff at drugshortages@fda.hhs.gov (for products regulated by CDER) or 
cbershortage@fda.hhs.gov (for products regulated by CBER). 
13  See 21 CFR 806.10.  As used in this guidance, a firm in the medical device context under 21 CFR 806.10 means a 
device manufacturer or importer.  See 21 CFR 806.10(a).  Moreover, device user facilities, manufacturers, 
importers, and distributors are subject to the medical device reporting regulations under 21 CFR part 803.  
14 See 21 CFR 107.240(a). 
15 See, e.g., section 582(b)(2) of the FD&C Act [21 U.S.C. 360eee1].  
16 See 21 CFR 606.121.  
17 See 21 CFR part 801, subpart B and https://www.fda.gov/medical-devices/device-advice-comprehensive-
regulatory-assistance/unique-device-identification-system-udi-system.  In some cases, the device itself must be 
directly marked with a UDI. 21 CFR 801.45. 
4 
  Contains Nonbinding Recommendations 
control data created for each lot,18 batch, or unit.  Product coding facilitates a correct 
accounting of affected product, so it may help a recalling firm accurately define and limit 
the scope of the recall.  Additionally, product coding may allow consignees to separate 
violative product lots from unaffected lots.  Product coding may also help the public, e.g., 
by helping consumers recognize an affected product in their possession.   
 
  Maintain distribution records.  Certain products have specific requirements related to the 
maintenance of distribution records.  Examples of distribution records requirements 
include but are not limited to:19 
 
  Distribution requirements for finished medical devices.20  
o
  Product tracing requirements for certain human prescription drug product 
o
transactions.21  
  Distribution and receipt records for blood and blood products.22   
o
  Distribution records for drug products for animals, medicated feed for animals, 
o
and Type A medicated articles.23   
Whether required or not, distribution records should be maintained by the recalling firm 
to facilitate the location of products being recalled. These records should be retained for a 
period of time that exceeds the shelf life and expected use of the product and is at least 
the length of time specified in other applicable regulations concerning records retention.  
(21 CFR 7.59(c)).  Distribution records should identify the direct accounts that received 
the recalled product by name, physical address where the product was delivered, and a 
contact telephone number.  Distribution records also must conform with any applicable 
requirements.  Any direct accounts that further distribute the product should maintain 
records of their own direct accounts to ensure that the recalling firms instructions are 
extended to all consignees in the distribution chain. 
 
2.  RECOMMENDED PROCEDURES FOR INITIATING A RECALL AND PERFORMING 
ACTIONS RELATED TO INITIATING A RECALL 
In addition to these preparations, FDA recommends that firms consider preparing, maintaining, 
and documenting written procedures (in paper or electronic format) for initiating a recall and 
 
18 On Sept. 23, 2020, FDA issued the Requirements for Additional Traceability Records for Certain Foods 
proposed rule (85 FR 59984).  If finalized as proposed, this rule would establish certain recordkeeping requirements 
for persons who manufacture, process, pack, or hold certain foods, including requirements related to establishing 
and maintaining traceability lot codes and linking the codes to other information identifying the food throughout the 
supply chain.  Additional information is available at https://www.fda.gov/food/food-safety-modernization-act-
fsma/fsma-proposed-rule-food-traceability. 
19 On Sept. 23, 2020, FDA issued the Requirements for Additional Traceability Records for Certain Foods 
proposed rule (85 FR 59984).  If finalized as proposed, this rule would establish certain recordkeeping requirements 
for persons who manufacture, process, pack, or hold certain foods, including requirements related to maintaining 
distribution records.  Additional information is available at https://www.fda.gov/food/food-safety-modernization-
act-fsma/fsma-proposed-rule-food-traceability. 
20 See 21 CFR 820.160.  
21 See, e.g., section 582(b)(1) of the FD&C Act [21 U.S.C. 360eee-1].   
22 See 21 CFR 606.165. 
23 See 21 CFR 211.196, 225.110, and 226.110, respectively. 
5 
  Contains Nonbinding Recommendations 
performing actions related to initiating a recall.  This recommendation does not supersede any 
specific recall plan requirements, e.g., for human or animal food.24  Written recall procedures 
help to minimize delays created by uncertainty as to the appropriate actions to take when a 
decision is made to initiate a recall.  In advance of when a recall may be needed, a firm should 
incorporate written recall procedures into its training for personnel to help ensure that necessary 
actions are carried out effectively and to minimize the disruptive effect a recall can have on the 
firms business.  Such procedures should be considered as part of a comprehensive written 
contingency plan for use in initiating and effecting a recall in accordance with [21 CFR] 7.40 
through 7.49, 7.53, and 7.55. (21 CFR 7.59(a)).     
For recalling firms, having specific procedures for initiating a recall and performing actions 
related to initiating a recall may help reduce the amount of time a violative product is on the 
market.  For consignees, having such procedures may help extend the recall throughout the 
distribution chain, in accordance with the instructions received from the recalling firm.   
A firms written procedures for initiating a recall and performing actions related to initiating a 
recall should assign responsibility and describe the steps to perform all actions as appropriate to 
the firm or facility, such as: 
  Ceasing distribution, shipment, and/or sales of affected product(s). 
 
  Developing a recall strategy.  As set forth in 21 CFR 7.42, a recall should be initiated 
according to an approved strategy developed by the recalling firm after considering 
various factors, including, but not limited to, the potential risk to those exposed to the 
product and the ease in identifying the product.  21 CFR 7.42(b) states which elements a 
recall strategy will address, including the depth of the recall.  In addition, FDA 
recommends that the recall strategy suit the individual circumstances of the particular 
recall and help guide the recalling firms decisions related to recall depth and the need for 
additional actions such as public warnings.  The recall strategy should take into account 
the possibility that the scope of the recall may expand should additional lots or products 
be shown to be affected. 
 
  Notifying direct accounts about the product being recalled, including what should be 
done with respect to the recalled product.  A recalling firm is responsible for promptly 
notifying each of its affected direct accounts about the recall.  (21 CFR 7.49(a)).  
Communication with appropriate points of contact at each direct account is the most 
effective way to ensure that direct accounts know the product in question is subject to a 
recall.  Timely recall communications allow the direct account to act quickly and 
effectively to implement the recall.  Where appropriate, instructing the direct account to 
further notify its own direct accounts about the recall is essential to extending the recall 
throughout the product distribution chain.   
 
 
24 See 21 CFR 117.139 and 507.38 (unless otherwise exempt from the requirements of 21 CFR parts 117 and 507, 
for human or animal food with a hazard requiring a preventive control, a firm must establish a written recall plan for 
the food).  See also the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for 
Human Food; Chapter 14: Recall Plan (October 2019) (when final, this guidance will represent FDAs current 
thinking on this topic).  We update guidances periodically.  For the most recent version of a guidance, check the 
FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 
6 
  Contains Nonbinding Recommendations 
As noted above, FDA encourages the use of electronic communications for conveying 
voluntary recall communications about FDA-regulated products.  If your recall 
communications plan specifies that you will contact your direct account by telephone, we 
recommend that your recall communications plan also specify that you will confirm that 
telephone communication in writing (e.g., follow up the telephone call with a written or 
electronic communication) and/or document the telephone communication in an 
appropriate manner.  (See 21 CFR 7.49(b)).   
 
  Providing response instructions to notified direct accounts.  The recall 
o
communication should include instructions for the method (e.g., written response 
form, telephone call or electronic communication) that the direct account can use 
to respond to the notification, and should include points of contact for follow-up 
communication at the recalling firm.  
 
  Including instructions for appropriate disposition of recalled product.  Direct 
o
accounts should be given clear instructions regarding appropriate disposition of 
recalled product, e.g., through return or destruction of the product.  Instructions 
for appropriate disposition of recalled product help the recalling firm and 
consignees ensure that the product will not remain a risk to the public.  
Disposition may be subject to federal, state, and local requirements.   
 
  When appropriate, notifying the public about a product that presents a health hazard.25 
 
B.  WHAT SHOULD A FIRM DO IF THERE IS AN INDICATION OF A PROBLEM WITH A 
DISTRIBUTED PRODUCT?   
Certain products have specific regulatory requirements related to identifying,26 investigating27 
and reporting28 product problems.  While compliance with regulatory requirements is necessary, 
we also recommend that all firms: 
Identify the problem.   As appropriate, a firm should implement procedures to identify indicators 
that there may be a problem with a distributed product that suggests it may be in violation of the 
FD&C Act and other laws administered by FDA.  Examples of such indicators may include but 
are not limited to:  
 
25 See also FDAs final guidance Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; 
Guidance for Industry and FDA Staff, which represents the current thinking of FDA on this topic.  We update 
guidances periodically.  For the most recent version of a guidance, check the FDA guidance web page at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 
26 See, e.g., requirements to review postmarketing reporting of adverse experiences for human drugs under 21 CFR 
314.80(b); see also quality program requirements for human cell, tissue, and cellular and tissue-based products 
(HCT/P) under 21 CFR 1271.160(b)(2); see also preventive control management components for food for humans 
(21 CFR 117.140) and food for animals (21 CFR 507.39).  
27 See, e.g., the requirement to maintain procedures for investigating the cause of medical device product, processes 
and quality system nonconformities under 21 CFR 820.100(a)(2)); see also the requirement to review drug product 
production records and investigate any failure or discrepancy under 21 CFR 211.192; see also verification 
requirements for transactions involving certain human prescription drugs in sections 582(b)(4), 582(c)(4), 582(d)(4) 
and 582(e)(4) of the FD&C Act [21 U.S.C. 360eee-1]. 
28 See supra footnotes 8-14 and accompanying text. 
7 
  Contains Nonbinding Recommendations 
  An internal report of a product specification deviation.  
  Out-of-specification testing results for a product.  
  Consumer complaints about a product.  
  Inspectional observations or laboratory analytical results related to a product, 
communicated by a regulatory authority, and indicating noncompliance with applicable 
product regulations.  
  Reports of adverse events, e.g., illness, injury, or death associated with product use.   
 
Investigate the problem.  The firms procedures should assign responsibility and describe the 
steps to investigate a problem with a distributed product.  These steps may include but are not 
limited to:   
  A timely investigation to determine whether a deviation in manufacturing occurred and, 
as applicable, whether the safety, effectiveness, purity, or potency of distributed products 
may have been affected or whether a product may be otherwise adulterated or 
misbranded. 
  A prompt evaluation by a qualified person and following established criteria, to ensure 
that potential risks are consistently and adequately assessed and investigated for products 
potentially affected.  
 
The recalling firm need not delay initiation of a voluntary recall pending completion of the 
investigation. 
 
Make decisions and take action.  The firms procedures should assign responsibility and describe 
the steps to ensure that decisions are made to control defective and potentially harmful products 
in a timely manner.  The procedures should address: 
 
  Deciding whether to initiate a voluntary recall. 
  The appropriate scope of the recall, e.g., the groups of units to be recalled as identified by 
product coding, or in instances where the product does not bear a code, a description of 
the units distributed within a specific date range or period of time.  For guidance on 
adequate product coding, see Question A in section III of this document.   
  The appropriate depth of the recall, i.e., depending on the products degree of hazard and 
extent of distribution, the firms recall strategy should specify the level in the distribution 
chain to which the recall is to extend.  (21 CFR 7.42(b)(1)). 
  The need to discontinue production and distribution of affected product. 
 
Consult with FDA about the problem.  If a firm has questions about its examination of a product 
problem, we encourage the firm to consult with FDA while its own investigation is ongoing.  A 
comprehensive list of FDA Recall Coordinator contact information, organized by product type 
and location, is available on FDAs website.29  
 
 
29 ORA Recall Coordinators, https://www.fda.gov/safety/industry-guidance-recalls/ora-recall-coordinators  
8 
  Contains Nonbinding Recommendations 
C.  HOW SHOULD A FIRM INITIATE A VOLUNTARY RECALL?   
A firm should initiate a voluntary recall by promptly notifying each of its affected direct 
accounts about the recall, and by issuing a press release or other public notice, if appropriate.  
FDA considers the date of a firms first communication about a recall, either to its direct 
accounts or to the public, to constitute the date of initiation.  
We recommend that the recalling firm follow the initiation procedures in its recall plan to 
implement the recall in accordance with 21 CFR 7.46 (firm-initiated recall).  This includes 
executing its prepared recall communications plan.  Among the information generally requested 
by the FDA under 21 CFR 7.46(a) are copies of the firms issued or proposed recall 
communications.  If provided, FDA will review the content of the proposed communications and 
recommend changes as appropriate. 
A recalling firm need not delay initiation of a voluntary recall pending FDAs review of its recall 
strategy or recall communications.  Section 7.49(c) of 21 CFR provides general content 
guidelines for recall communications.30   
In addition, a recalling firm should clearly identify the level in the distribution chain to which the 
recall is to extend and should provide instructions to direct accounts to extend the recall to their 
own direct accounts if the product could have been further distributed.  We have previously 
issued procedural guidance regarding press releases and written recall notification letters.31  
Nevertheless, and notwithstanding any requirements for firms to submit a report to FDA for 
certain products, a firm that initiates a recall because it believes the product to be violative is 
requested to notify FDA immediately.  (21 CFR 7.46(a)).32 
As appropriate, a recipient of a recall communication, i.e., a notified direct account or consignee, 
should implement its own recall initiation procedures to extend the recall promptly to its direct 
accounts that may have received the affected product, in accordance with the instructions 
received from the recalling firm.  (See 21 CFR 7.49(d)).  Where necessary, follow-up 
communication should occur for any direct account that fails to respond to a recall 
communication to ensure the direct account has received and understands the recall 
communication.  (See 21 CFR 7.49(c)(2)). 
 
D.  HOW DOES FDA WORK WITH A RECALLING FIRM TO INITIATE A VOLUNTARY 
RECALL IN A TIMELY MANNER?   
FDA is committed to working cooperatively with a recalling firm whenever possible to facilitate 
the orderly and prompt removal of, or correction to, a violative product in the marketplace, 
particularly when the product presents a danger to public health.  FDA recall coordinators 
organized by product type (e.g., a food, drug, medical device, or tobacco product) and located 
throughout the country, act as Agency points-of-contact for recalling firms and offer assistance.  
Recall coordinators provide a recalling firm with information about the recall process and are 
available to work closely with the firm throughout the course of the recall.  For example, recall 
coordinators may assist the firm with determining whether the action is a recall as defined in 21 
 
30 See also supra footnote 6 and accompanying text. 
31 Information on Recalls of FDA Regulated Products,  
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls  
32 But see footnote 33.  
9 
  Contains Nonbinding Recommendations 
CFR 7.3(g), and if so, with developing an appropriate recall strategy; with reviewing the 
recalling firms communications to direct accounts or to the public about the recall; and with 
monitoring the destruction, reconditioning, or disposition of the recalled product.  For certain 
products, FDA recall coordinators may assist by referring the firm to another regulatory body 
outside FDA with primary responsibility for monitoring the product recall (e.g., voluntary recalls 
of certain alcoholic beverages are monitored by the Alcohol and Tobacco Tax and Trade 
Bureau). 
A recalling firm located in the United States should contact a Division Recall Coordinator within 
the FDA Office of Regulatory Affairs (ORA).33  If the firm is located outside of the United 
States and is recalling a product exported to the United States, then the recalling firm should 
contact ORA Headquarters.  A comprehensive list of FDA Recall Coordinator contact 
information, organized by product type and location, is available on FDAs website.34  
FDA officials may initiate discussions with a firm about a product problem.  When FDA 
determines that a distributed product violates the law, it may inform the firm and may 
recommend that it cease distribution and recall the product in accordance with 21 CFR part 7 and 
Agency procedures.  If the firm voluntarily decides under any circumstances to recall the 
product, then the action is considered a firm-initiated recall under 21 CFR 7.46.   
Under certain circumstances, FDA may also request that a firm initiate a recall under 21 CFR 
7.45.35  FDA-requested recall is generally pursued only after conducting discussions with the 
firm.  FDA must make all of the following determinations before requesting a recall under 21 
CFR 7.45: 
(1) That a product that has been distributed presents a risk of illness or injury or gross 
consumer deception;  
(2) That the firm has not initiated a recall of the product; and 
(3) That an Agency action is necessary to protect the public health and welfare.  
 
During an FDA-requested recall the recalling firm may be asked to provide FDA with any or all 
information listed in 21 CFR 7.46(a).  This information includes, but is not limited to, the 
identity of the product involved, the reason for the removal or correction, and the date and 
circumstances under which the product deficiency or possible deficiency was discovered.  If the 
firm agrees to recall the product based on FDAs request, then the action is still considered a 
voluntary recall.   
In the event that a recalling firms actions do not adequately protect the public from a violative 
product, i.e., the firm fails to initiate a recall effectively, FDA may consider taking other 
appropriate actions.  
 
33 For recalls of CBER-regulated products included in CBERs Direct Recall Classification (DRC) program, the 
DRC program is the primary means by which firms communicate with FDA regarding the recall.  The DRC program 
refers to the classification of biologics recalls directly by personnel in CBER.  Further information on the DRC 
program may be found at:  https://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-
evaluation-research/direct-recall-classification-program  
34 ORA Recall Coordinators, https://www.fda.gov/safety/industry-guidance-recalls/ora-recall-coordinators  
35 For medical devices, where FDA finds that there is a reasonable probability that the device would cause serious, 
adverse health consequences or death, FDA may initiate a mandatory recall by following certain procedures under 
21 CFR part 810. 
10