Division of Compliance Management and Operations
GUIDANCE FOR INDUSTRY
Product Recalls, Including
Removals and Corrections
This guidance document is intended to provide guidance and
instructions to FDA regulated industry for obtaining information to help fulfill the
Agencys plans regarding product recalls. It represents the agencys current
thinking on product recalls. This guidance does not create or confer any rights for or on
any person and does not operate to bind the Food and Drug Administration (FDA) or the
public. An alternative approach may be used if such approach satisfies the requirements of
the applicable statute, regulations, or both. To discuss an alternative approach, contact
the FDA staff responsible for implementing this guidance. If you cannot identify the
appropriate FDA staff, call the appropriate number listed on the title page of this
guidance. This guidance is available electronically to the public.
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs
Office of Enforcement
Division of Compliance Management and Operations
1350 Piccard Drive HFC-210
Rockville, MD 20850
Date Issued: 11/3/03
This guidance is intended to assist those members of industry regulated by the Food and
Drug Administration (FDA) in handling all aspects of a product recall, including all
corrections and removals. The guidance includes a checklist of documentation and
information that FDA utilizes to evaluate, classify, monitor and audit product recalls.
Various statutory provisions and regulations, described below, authorize 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 FDA's request.
This guidance provides more specific recommendations and applies to both mandatory and
voluntary recalls of all FDA-regulated products (i.e. food, including animal feed; drugs,
including animal drugs; medical and radiological devices; cosmetics; human biological
products including blood; and human tissue.)
This is a level 2 guidance document published for immediate implementation in
accordance with FDA's good guidance practices (21 CFR 10.115). This guidance sets forth
the agency's existing practices in the handling of recalls. Interested parties may submit
comments on this guidance to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be
identified with the docket number listed in the notice of availability that publishes in
the Federal Register.
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.
Certain statutory provisions authorize mandatory recalls of infant formula (21 USC §
350a(e)-(g)), medical devices (21 USC § 360h(e)), and human biological products (42 USC
§ 262). Additionally, FDA regulations set forth specific requirements for mandatory
infant formula recalls (Subpart E of 21 CFR Part 107), medical device corrections and
removals (21 CFR Part 806), and mandatory human tissue recalls (Subpart D of 21 CFR Part
1270). In addition to the requirements in these statutory provisions and regulations, the
guidance's specific recommendations would also apply to these types of recalls. In the
context of a mandatory recall, those conditions in the guidance that are already set forth
in a statute and/or regulation would be requirements, rather than recommendations, under
the applicable statute and/or regulation.
FDA believes the cooperation of manufacturers and distributors in expediting recall
activities is vital because of the determination that a distributed product is potentially
hazardous to the public or animals and/or is in violation of the Federal Food, Drug, and
Cosmetic Act (the Act). Recalling firms are urged to notify the local FDA District Recall
Coordinator as soon as a decision is made that a recall is appropriate and prior to the
issuance of press or written notification to customers. For your local recall coordinator,
please check the following website: http://www.fda.gov/ora/inspect_ref/iom/iomoradir_monitors.html#recall
It is recommended that you submit the information outlined in this guidance to your
local FDA District Recall Coordinator as soon as possible after the decision to recall is
made and the coordinator notified. It is recommended that you do not wait to submit this
information until ALL applicable information is prepared and assembled prior to FDA
notification. This "early" notification will allow FDA the opportunity to review
and comment on your written notification and to offer guidance and assistance in your
A. Recall Submission to FDA
We recommend that you include the following information in your recall submission:
- PRODUCT INFORMATION:
- Product name (include brand name and generic name)
- Model, catalogue, or product order number(s)
- Description of the product
- Include if product is powder, liquid, tablet, capsule, etc.
- Include the intended use or indications.
- If the product is perishable, include the expected shelf life.
- Include type of packaging (i.e. box, flexible plastic, glass).
- TWO COMPLETE SETS OF ALL
labeling to your Local FDA District Recall Coordinator. Include:
- Product labeling (including ALL private labels)
- Individual package label
- Case label (photocopy acceptable)
- Package Inserts
- Directions for Use
- Promotional Material (if applicable)
Additional information for Drug recalls:
- NDA/ANDA/NADA Number
- NDC Number
- Indicate if prescription or OTC
- Route of Administration
Additional information for Medical Device recalls:
Additional information for Biological recalls:
CODES (Production Identification Numbers):
- License number
- Registration number
- Lot/Unit Numbers
(NOTE: If "all lots" are involved or the product is not coded, explain how
non-recalled, or reintroduced product may be distinguished from product subject to recall.
Provide an explanation of your lot number coding system.)
- Expiration date(s) or Use by date(s) or Expected shelf life of product.
- Serial numbers (medical devices)
- UPC codes
- Firm name, address, city, state, zip code
- Identify firm type (i.e. manufacturer, importer, broker, repacker, own-label
CONTACTS for Recalling Firm:
- Name/title/phone/fax number/e-mail address for RECALL contact
- Name/title/address/phone/fax number of the most responsible individual for the recalling
- Name/title/phone/fax number/e-mail address for public contact
IDENTIFY FIRM RESPONSIBLE FOR THE VIOLATION/PROBLEM:
- Firm name, address, city, state, zip code
- FDA registration number, if applicable
REASON FOR THE RECALL:
- Firm name, address, city, state, zip code
HEALTH HAZARD ASSESSMENT:
- Explain in detail how product is defective and/or violative.
- Explain how the defect affects the performance and safety of the product. (Also see #5,
Health Hazard Assessment)
- If the recall is due to the presence of a foreign object, describe the foreign objects'
size, composition, hardness, and sharpness.
- If the recall is due to the presence of a contaminant (cleaning fluid, machine oil,
paint vapors), explain level of contaminant in the product. Provide labeling, a list of
ingredients and the Material Safety Data Sheet for the contaminant.
- If the recall is due to failure of the product to meet product specifications, provide
the specifications and report all test results. Provide copies of any sample
- If the recall is due to a label/ingredient issue, provide and identify the correct and
incorrect label(s), description(s), and formulation(s).
- Please explain how the problem occurred and the date(s) it occurred.
- Explain how the problem was discovered and the date discovered.
- Please explain if the problem/defect affects ALL units subject to recall, or just a
portion of the units in the lots subject to recall.
- Explain why this problem affects only those products/lots subject to recall.
- Provide detailed information on complaints associated with the product/problem:
- Date of complaint
- Description of complaint -include details of any injury or illness
- Lot Number/Serial Number involved
- Medical Device Complaints - include copies of MedWatch-MDRs
- If a State agency is involved in this recall, identify Agency and contact.
- Drug recalls (NDA/ANDA/NADA/ANADA products) provide details for
any Field Alert submitted
VOLUME OF RECALLED PRODUCT:
- Please provide your assessment of the health risk associated with the deficiency.
NOTE: A recall decision does not depend solely on the health risk of the product.
Defective products and misbranded products where no health hazard exists are still in
violation of the law and should be recalled.
- For recalls of products such as human tissue and biological products, including
blood products, due to donor suitability/viral marker testing, provide copies of:
- donor screening form
- test results, including viral marker test results for implicated unit, viral marker test
results for subsequent donations, and, if available, confirmatory test results.
- SOPs that show the acceptance criteria for donor screening and/or viral
marker testing, that was not met for the product(s) subject to recall.
- Total quantity produced
- Date(s) produced
- Quantity distributed
- Date(s) distributed
- Quantity on HOLD by Recalling firm and its distribution centers.
- Indicate how the product is being quarantined
- Estimate amount remaining in marketplace
- distributor level
- retail level
- pharmacy or veterinary level (drugs)
- user level (i.e. Medical Devices)
- Provide the status/disposition of marketed product, if known, (e.g. used,
transfused, implanted, used in further manufacturing, or destroyed).
- Number of DIRECT accounts (customers you sell directly to) by type, for example:
- users (medical devices - hospitals, clinics, laboratories)
- consumers (internet or catalog sales)
- federal government consignees
- foreign consignees (specify whether they are wholesale distributors, retailers or users)
- Geographic areas of distribution, including foreign countries.
- Provide a consignee list (names/address/city/state/contact name/phone number) to
the local District Recall Coordinator. Be sure to include any foreign (including Canadian)
customers and federal government consignees (USDA agencies, Veterans Affairs, Department
- Indicate what the consignee list represents (i.e. all customers who were shipped
recalled product; all customers who were sold recalled product; all customers who
may have been shipped or sold recalled product because it was
sold to them within the applicable time period.)
- Was product sold under a government contract? If yes, provide contract number, contract
date and implementation date. If no, indicate so.
- Was product sold to any federal, state, or local agency involved in the school lunch
program? If yes, list the consignees and provide quantity and sale and shipment date.
In addition, it is recommended that you notify both "ship to" and "bill
to" customers of the recall so that
- "Ship to" customers retrieve the product from their location.
- "Bill to" customers, if responsible, initiate the subrecall.
- Indicate the level in the distribution chain to which you are extending the recall.
(i.e. wholesale/retail/pharmacy/medical user)
If your recall only extends to the wholesale/distributor level, we recommend that you
explain your rationale for not recalling to retail/pharmacy level.
- Indicate the method of notification (i.e. mail, phone, facsimile, e-mail). It is
advisable to include a written notification so customers will have a record of the recall
and your instructions.
- Indicate how letters will be sent to customers (e.g. overnight mail, first class mail,
certified mail, facsimile)
- If initial notification is by phone, provide a copy of the phone script to FDA.
- If you have a web site, you should consider posting the recall notification on the web
site as an additional method of recall notification. (Note: This is not recommended as a
sole means of customer notification.)
- Report on what you have instructed customers to do with the recalled product.
- It is helpful for recalling firms to know the name and title of the Recall Contact for
each of its consignees. Addressing a recall notification letter to a recall contact will
expedite the recall process and reduce the potential for the notification letter to get
- If product is to be returned, explain the mechanics of the process.
- Explain if this recall will create a market shortage that will impact on the consumer.
- Report on recall effectiveness check strategy. Include your actions for
non- responders. See: <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm>
- Determine and provide your course of action for out-of-business distributors.
- Provide a proposed method of destruction, if applicable.
- If the product is to be "reconditioned", explain how and where the
reconditioning will take place. Please provide details of the reconditioning plan to your
local FDA District Recall Coordinator before implementation. All reconditioning must be
conducted under any applicable CGMPs.
- Describe how reconditioned product will be identified so it is not confused with
recalled (pre-reconditioned) product.
In addition, we recommend that:
- You contact your local FDA District Recall Coordinator prior to product destruction. FDA
will review your proposed method of destruction and may choose to witness the destruction.
- The recalling firm and customers keep adequate documentation of product destruction (and
whether or not destruction was witnessed by an FDA investigator).
- Field corrections, (i.e. product relabeling), be performed by recalling firm
representatives, or under their supervision and control. It is not recommended that a
disinterested party such as a wholesaler or retailer be responsible for field corrections.
For Drug Recalls: Misbranded drugs for re-labeling should be returned to the recalling
- You contact your local District Recall Coordinator prior to release of reconditioned
B. Public Notification
- PRESS RELEASE:
In a situation where the product may pose a significant health hazard
and recalled product is in the hands of consumers, a press release is usually appropriate.
Issuance of a press release should be the highest priority and it should be issued promptly.
Unique situations will be handled on a case-by-case basis.
- GUIDANCE FOR WRITTEN RECALL NOTIFICATION LETTERS: Recall Notifications
should be flagged in large bold print "URGENT: [insert "FOOD",
"DRUG", "MEDICAL DEVICE", etc.] RECALL or CORRECTION.
Envelopes should be similarly flagged. FDA recommends that you include the following
information in a recall notification:
- PRODUCT IDENTIFICATION:
- Include an accurate and complete description of the product and any codes used to
identify the product, e.g. lot/unit numbers, expiration date, serial numbers, catalog
numbers, model numbers, and UPC codes.
- Consider including a copy of the product label with the recall notification. This could
be helpful for wholesalers and retailers in identifying and removing the recalled product.
- DESCRIPTION OF THE PROBLEM:
- Identify the problem and any potential health hazard(s) associated with
- DEPTH OF THE RECALL:
- The recall notification should clearly identify the depth to which the
recall is to extend (e.g. wholesale, retail, or user level). If the recall is to the retail
level, a statement should read This recall is to the retail level.
- If the product could have been further distributed by your customers, then you should
include instructions to subrecall. Subrecall instruction should also include the depth of
the recall, e.g. If you have further distributed this product, you should notify
your customers to the retail level.
- If your customers are instructed to conduct subrecalls, it is advisable to provide them
with the date range that the recalled product was distributed. Wholesalers/ distributors
may need this information in order to identify customers they shipped/sold recalled
You should consider providing a subrecall letter with your notification package for your
customers to further notify their sub accounts. You are then assuring that the information
to sub accounts is accurate and complete.
- INSTRUCTIONS TO CUSTOMERS:
- Your recall INSTRUCTIONS should be clear. For example:
- Remove product from sale
- Cease distribution
- Subrecall (if appropriate)
- Return product
- Explain procedure for product correction
- Include a RETURN RESPONSE card/form. This return response card/form
should include all instructions from your recall letter. Your customers should be
required to indicate that they followed every instruction.
Provide examples of ALL recall communications (include letters,
attachments, envelope) to your Local District Recall Coordinator.
IMPORTANT: All customers in the distribution chain should be NOTIFIED
of the recall, preferably in writing. Here are some examples of why this is important.
- In the case of a human drug recall, FDA does not believe it is appropriate for a
salesman to visit a doctor's office and remove product without notifying the physician or
responsible staff. Physicians may be treating patients that may suffer or have suffered
some adverse effect from the drug subject to recall. With knowledge of the recall and the
reason for the recall, the physician can better evaluate a patient's condition and provide
appropriate patient care.
- In the case of products sold at retail stores, FDA does not believe it is appropriate
for a salesman or broker representatives to remove product from retail shelves without
informing store management of the recall. Failure to inform store management of the recall
could result in product that is in storage, in transit to the store, or returned by
customers, being offered for sale. The salesmen or broker representatives may not have
knowledge or access to the recalled products stored in back rooms. Recalled products that
are in-transit to the store would then be sold to customers. Recalled products returned by
customers may be placed back on store shelves.
C. Evaluation of the Recall
- EFFECTIVENESS OF THE RECALL:
It is the recalling firms responsibility to assure
that the recall is effective. Therefore, we recommend that you consider effectiveness
checks for every recall. The purpose of an effectiveness check is to verify your recall
notification letter was received by the customer, that the customer read and understood
the letter and followed the recall instructions. The effectiveness check should also
verify your recall reached the appropriate level in the distribution chain.
The effectiveness check is your means of evaluating the effectiveness of your recall.
If your effectiveness checks indicate that the recall notification was not received, read
and/or instructions followed, then you should take necessary steps to make the recall
effective. These steps may involve sending out a follow up notification that better
identifies the product, better explains the problem and/or provides better instructions to
Your District Recall Coordinator will provide a copy of a FDA document, Methods
for Conducting Recall Effectiveness Checks.
Note: In addition to the effectiveness checks conducted by recalling firms, FDA may
also contact a percentage of your customers (referred to as audit checks) as a means of
assuring the recalling firm and its consignees are carrying out their recall
responsibilities. If FDA's audit checks determine the recall to be ineffective,
the recalling firm (or sub recalling firm if such is the case) will then be asked by FDA
to take appropriate actions, including re-issuing recall notifications.
- RECALL STATUS REPORTS:
You will be asked to provide Recall Status Reports after
initiating a recall (usually on
a monthly basis but more frequently when indicated) to your local District Recall
Coordinator. The reports requested will usually include the following information:
- Dates customers notified
- Number of customers notified
- Number of customers responding
- Quantity of RECALLED product returned or accounted for
- Details of your recall effectiveness checks
- ROOT CAUSE OF THE PROBLEM THAT RESULTED IN THE RECALL:
We recommend that you provide
this information to your local District Recall Coordinator once the root cause has been
established. It is important to establish the root cause of the problem so that
appropriate preventative measures can be taken.
- CORRECTIVE ACTIONS TO PREVENT FUTURE OCCURRENCES OF THE PROBLEM:
We recommend that
you explain the corrective actions planned or underway that will prevent a similar problem
from occurring. We further recommend that you provide this information to your local
District Recall Coordinator when it has been established.
- TERMINATION OF THE RECALL:
We recommend that you evaluate your recall for termination
when all possible customer responses have been received and it is reasonable to assume
that the recalled product has been recovered, corrected, reconditioned, or destroyed. A
final status report and documentation of recalled product disposition should be provided
to your local District Recall Coordinator before FDA will consider formal termination of
the recall action. See: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=7.55
Note: Upon receipt of necessary termination information, the districts recall
coordinator will prepare a recall termination document for Center and/or district
management concurrence. When concurrence is obtained, the district office will notify the
recalling firm that FDA considers the recall terminated.
Additional Guidance and/or Requirements:
21CFR Part 7, Subparts A and C - Recalls - General guidelines
21CFR Part 107, Subpart E - Mandatory recall of Infant Formula
21 CFR Part 1270 - Human Tissue
PHS Act - 42 U.S.C. 262 - Mandatory recall of biological products
21 CFR Part 806 - Medical Device Corrections and Removals
FD&C Act, 518(e) - Mandatory Device Recalls
FDA DISTRICT RECALL COORDINATORS
A current list of FDA recall coordinators can be found on FDAs website at: