From: Alicia White (CE CEN)

To: Wisecup, Tyra

Subject: [EXTERNAL] Whole Foods Market Undeclared Milk in Beef Meatballs in Marinara

Date: Wednesday, February 24, 2021 7:41:13 PM

Thanks for the follow-up. I just received confirmation that we are pushing up the timeline on the 

execution of an allergen change. The new dates are: 3/15 to communicate and 3/29 to implement.

Thanks, 

Alicia

Alicia K. White

Vice President and Associate General CounselMerchandising, Operations and Regulatory 

Whole Foods Market Legal Team

550 Bowie Street

Austin, TX 78703

512.542.0730 Phone

512.482.7730 Fax

alicia.white@wholefoods.com

CONFIDENTIALITY NOTICE:

This transmission may be: (1) subject to the Attorney-Client Privilege, (2) an attorney work product,

(3) strictly confidential, or read; and/or (4) processed by another individual on my behalf. If you are 

not the intended recipient of this message, you may not disclose, print, copy or disseminate this 

information. If you have received this in error, please reply and notify the sender and delete the 

message. Unauthorized interception of this e-mail is a violation of federal criminal law.

From: "Wisecup, Tyra" <Tyra.Wisecup@fda.hhs.gov>

Date: Wednesday, February 24, 2021 at 1:11 PM

To: "Alicia White (CE CEN)" <Alicia.White@wholefoods.com>

Subject: [External] RE: [EXTERNAL] Whole Foods Market Undeclared Milk in Beef Meatballs in 

Marinara

WARNING: This email was received from a source outside of Whole Foods Market. Do not respond, open

any attachments, or click on links in the message if you do not know the sender or cannot verify the

integrity of the message.

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you 

recognize the sender and know the content is safe. 
Afternoon,

We have already had a discussion with USDA/FSIS who is the regulatory agency for meat 

products (with caveats). We will be providing them the information that has been submitted 

and they will take it from here. So I don’t think that I need to meet with you about it.

As to your meeting held today – are you going to be able to expedite the changes? Every 

opportunity to do so would be helpful. Not just to us, but to your customers and I know they 

are important to you.

Oh wait. I see another email from you. Let me see what it says before I hit send...not a 

concern – information that I already had.

Okay. If you could tell me what the decision was from your meeting, I would appreciate it. 

Have a lovely day!

Tyra

From: Alicia White (CE CEN) <Alicia.White@wholefoods.com>

Sent: Wednesday, February 24, 2021 11:57 AM

To: Wisecup, Tyra <Tyra.Wisecup@fda.hhs.gov>

Subject: [EXTERNAL] Whole Foods Market Undeclared Milk in Beef Meatballs in Marinara

Tyra-The attached press release hasn’t gone out yet, but I wanted you to see it first. I am 

available today to discuss the issue and how our new process in Section 4.b and c will

prevent this type of event. We also had a call today to see if we can further expedite this 

new process. It is currently set for 4/19/21. Let me know if you want me to set up a call.

Thanks, 

Alicia

Alicia K. White

Vice President and Associate General CounselMerchandising, Operations and Regulatory 

Whole Foods Market Legal Team

550 Bowie Street

Austin, TX 78703

CAUTION: This email originated from outside of the organization. Do not click links or open attachments 

unless you recognize the sender and know the content is safe. 
512.542.0730 Phone

512.482.7730 Fax

alicia.white@wholefoods.com

CONFIDENTIALITY NOTICE:

This transmission may be: (1) subject to the Attorney-Client Privilege, (2) an attorney work 

product, (3) strictly confidential, or read; and/or (4) processed by another individual on my 

behalf. If you are not the intended recipient of this message, you may not disclose, print, 

copy or disseminate this information. If you have received this in error, please reply and 

notify the sender and delete the message. Unauthorized interception of this e-mail is a 

violation of federal criminal law.
Memorandum 

Date: October 8, 2020

From: Compliance Officer

Dietary Supplement and Labeling Assessment Branch, HFS-608 

Division of Enforcement

CFSAN, Office of Compliance

Subject: Center Decision Memorandum: Warning Letter Recommendation

To: Office of Chief Counsel, GCF-1

CMS # 610862

Manufacturer: Whole Foods Market 

FEI 3007331558

CFSAN supports issuance of a Warning Letter to the above referenced firm for violations of sections 

301(k) and 301(c) of the Act [21 U.S.C. §§ 331(k) and 331(c)]. All charges are added.

As a grocery store chain, Whole Foods Market (WF) is not subject to 21 CFR 117 Subpart C, Preventive 

Controls and, while they may be

.

Recalls for which WF was evaluated

for the time frame of October 2014 through June 2020. It was determined that not all of 

these RES events were related to misbranding. A decision was made to 

The RES event details for each of the events were uploaded into the Firm Background tab in CMS. 

These details were provided by WF and entered by the Recall Coordinator for the recalling ORA 

Division. The event details ho

However, interstate is reported by Whole Foods for the recalls listed in the letter. In 

some instances, 

However, it is our belief 

www.fda.gov

(b) (5) (b) (5) (b) (5)

(b) (5)

(b) (5)

(b) (5)

(b) (5)
Center Decision Memo: Warning Letter Recommendation 

MARCS-CMS #610862

 P a g e | 2

All RES events are now captured in CMS as Work Activities 

. All 11 RES related Work Activities related to this letter are linked in CMS to this case. 

recalls are listed in the examples of recalls included in the Warning Letter for review. Labels 

and additional information are available in the linked Work Activities. The following are the RES events 

covered in this action:

Recall

Event 

ID

Firm FEI

Recall

Initiation 

Date

Center

Classification 

Date

CMS 

WA

# of 

products

Note: RES events highlighted are included as examples in the Warning Letter for review.

CFSAN’s draft letter is attached for the review. This draft letter has been 

approved by CFSAN and is pending final review and clearance. Per most recent directive, 

 will review all charges. 

If you have any questions or need to discuss this case, you may contact me by e-mail at 

tyra.wisecup@fda.hhs.gov or by telephone at 240-402-5854.

Tyra S. Wisecup

(b) (5)

(b) (5) (b) (5) (b) (5)

(b) (4)

(b) (5) (b) (5) (b) (5) (b) (5) (b) (5) (b) (5)
DocuSign Envelope ID: 7C6C4974-87A9-42E4-8711-B0834F00E87D 

Ms. Tyra Wisecup 

Compliance Officer

United States Food and Drug Administration 

Center for Food Safety and Applied Nutrition 

5001 Campus Drive

Office of Compliance (HFS‐ 608), Division of Enforcement 

College Park, Maryland 20740‐ 3835

Re: Response to Warning Letter CMS # 610862 (December 16, 2020) 

Dear Ms. Wisecup:

I write in response to the Warning Letter that Whole Foods Market received from the Food and 

Drug Administration on December 16, 2020, asserting that Whole Foods Market has engaged in 

a pattern of receiving and offering for sale certain food products that are misbranded because 

they do not bear accurate allergen information as required under section 403(w) of the Federal 

Food, Drug, and Cosmetic Act. I am the Chief Operating Officer of Whole Foods Market, and in 

that capacity oversee all store operations, including system improvements, process, controls, 

and procedures. I am also a member of the Whole Foods Market Executive Team. I want to 

convey that Whole Foods Market takes this issue very seriously. As described in detail below, 

the company has undertaken and continues to implement, company-wide efforts to improve our 

ability to ensure that food we sell in all of our retail stores is labeled with accurate allergen 

information. 

We have taken a comprehensive approach to identify the potential causes of allergen-related 

recalls and the corrective actions that would be most effective in addressing those causes. We 

have determined that the allergen-related recalls that Whole Foods Market has conducted have 

occurred for one of two reasons: (1) a system error for our “prepared food products” (those 

products prepared at an individual retail store), which could include both incorrect information 

in our data system for a particular ingredient or product, or error at the retail level in preparing 

and/or labeling a food product for sale in a specific retail store; or (2) a supplier error, where a 

“supplier-provided finished product” (products received by a retail store already packaged and

labeled) is not labeled correctly. We have taken extensive measures to address both of these 

areas of potential vulnerability, and we have bolstered these actions by centralizing our 

oversight of retail food safety at the corporate level, which will help ensure consistency across all 

regions and strengthen our food safety processes and culture.1

As background, Whole Foods Market believes customers within different regions around the 

country have different tastes and needs. We take pride in a region’s ability to create different

1 While the Warning Letter cites five specific recalls, we understand that these recalls were just intended 

to be examples. We think the actions described in this response would clearly address the causes of those 

five recalls. However, we have not addressed each recall specifically in this response. Our specific 

corrective actions for each recall were submitted to the applicable FDA recall coordinator as part of our 

overall efforts in effectuating each recall. The efforts we describe in this response are intended to address 

broadly the potential causes of an allergen-related recall.

Portions of this document contain Trade Secrets / Confidential Commercial Information 

exempt from disclosure under the Freedom of Information Act, 5 U.S.C. § 552(b)(4), 

and we request it be handled accordingly.
DocuSign Envelope ID: 7C6C4974-87A9-42E4-8711-B0834F00E87D 

Ms. Tyra Wisecup

United States Food and Drug Administration 

January 8, 2021

Page 2 of 9

prepared food recipes, procure unique ingredients, and take region-specific initiatives that meet 

the tastes and needs of customers within their region. While Whole Foods Market still holds 

these values, we believe that lack of centralized corporate oversight into these decisions led to 

many of the recalls that we have conducted due to undeclared allergen ingredients. To minimize 

this risk, over the past few years Whole Foods Market has undertaken a company-wide effort to 

centralize many functions at a corporate level, including our food safety program, data 

operations, and oversight of our retail stores. This centralization includes coordinated 

purchasing and supply chain decisions for foods sold in retail stores and for ingredients used to 

prepare foods at retail stores, recipe development for retail prepared foods, and development 

and implementation of and training on centralized food safety processes and procedures, 

including specifically with respect to allergen management.

Before this centralization effort, certain purchasing, supply chain, and recipe formulation 

decisions were made at the regional or store level, and some recalls were also effectuated at that 

level. This means that prepared food recipes, as well as ingredient sourcing and purchasing, 

may have varied by regions or even individual stores, and product composition was more 

challenging and complex to track and ensure accuracy. Under the new centralized framework, 

prepared food recipes will be standardized globally at the corporate headquarters, and 

purchasing and sourcing decisions will be centrally managed. Each prepared food item will have 

a single recipe and either a single supply chain for each ingredient or multiple sources of exactly 

the same ingredient; the data for each item used to generate product labels will also be managed 

centrally. Further, data regarding already manufactured products that are sold in stores will be 

managed at a corporate level, as will approval for product suppliers. In Appendix A, we have 

provided a case study example of how the changes we have made will impact product 

preparation and information accuracy.

As discussed in more detail below and documented in the attached, we have initiated and are 

undertaking the following actions:

1. Centralized oversight of all retail operations at a corporate level. We created a Vice 

President position to oversee global retail food safety, and developed and implemented 

standardized food safety protocols, recipe development processes for foods prepared inhouse, and supplier approval processes. 

Created a global allergen recall task force, which is charged with assessing allergen 

recalls, identifying any needed process improvements company-wide, and overseeing 

corrective actions.

3. Enhanced our supplier approval program for regionally sourced prepared foods and 

bakery products. This process is now centralized at the corporate level and conforms to 

the standards we use to approve suppliers of packaged food products.

4. Reviewed and made necessary changes to internal procedures relating to product 

preparation, label accuracy, and accountability for errors. 

5. Implemented a policy for the Recipe Execution across all retail locations. This policy 

increases in-store requirements for adhering to approved recipes for foods prepared inhouse. Our Team Members at each retail location received training in this policy and 

other enhanced food safety protocols.

2.

Portions of this document contain Trade Secrets / Confidential Commercial Information 

exempt from disclosure under the Freedom of Information Act, 5 U.S.C. § 552(b)(4), 

and we request it be handled accordingly.
DocuSign Envelope ID: 7C6C4974-87A9-42E4-8711-B0834F00E87D 

Ms. Tyra Wisecup

United States Food and Drug Administration 

January 8, 2021

Page 3 of 9

6. Significantly enhanced our retail audit program. This enhanced audit program includes 

a retroactive audit, or “clean-up,” of our ingredient information, recipe storage, and 

label generating systems, as well as regular future company-wide audits of the accuracy 

of recipe and ingredient information.

7. Began the roll-out of a Food Safety Accountability Policy that includes compliance with 

product labeling to ensure that each team member is held to the same food safety 

requirements and expectations company-wide. 

We are confident that these actions will collectively ensure that food products sold in our stores 

are properly labeled and accurately declare the presence of allergens. We hope this information 

helps to convey how critical this issue is to Whole Foods Market. We would appreciate the 

opportunity to meet with you and Mr. Correll, and anyone else appropriate at the agency to 

discuss our actions in more detail, answer any questions you might have, and receive any 

feedback on the information that we have provided. We can make our team available at your 

convenience, and will follow up shortly to schedule this meeting.

I. Centralized Oversight of Retail Operations and Supplier Approval

As you indicate in the Warning Letter, over the past year, Whole Foods Market has conducted a 

number of recalls of products that did not properly declare the presence of major food allergens. 

Our regulatory compliance team and senior food safety leaders identified this as a particular 

area of concern at the start of 2020, and immediately undertook a number of initiatives at the 

corporate level to strengthen our allergen controls and our broader food safety system.

In addition, we are in the midst of a multi-year process of centralizing all of our food safety 

organization and processes, our data operations, our prepared foods system, our data 

information system, and our supplier approval programs. We believe this centralization and 

increased corporate oversight will significantly reduce the opportunities for undeclared 

allergens and other food labeling errors. These centralization efforts have been underway for 

the past few years and implementation will continue throughout this year. We provide more 

detail below about the various specific steps we have taken to help strengthen our allergen 

control program.

A. Centralizing Food Safety Organization and Processes

We have taken a number of measures to centralize our oversight of food safety, which we believe 

will broadly ensure consistency across retail locations and allow us to streamline and verify the 

accuracy of key information. Specifically:

• In October 2019, Whole Foods Market created a new position for Vice President, Retail 

Food Safety, which is intended to globally oversee food safety in our retail stores. Before 

this, we did not have a senior corporate position dedicated specifically to oversight of 

retail food safety. This position is responsible for developing store level Standard 

Operating Procedures and training programs, investigating in-store safety issues, and 

ensuring that continuous improvement programs are developed, implemented, and 

audited. We hired Jeff Edelen, a former leader at The Kroger Co. who was a senior 

manager in retail food safety and regulatory compliance across 2800+ stores in the 

United States.

Portions of this document contain Trade Secrets / Confidential Commercial Information 

exempt from disclosure under the Freedom of Information Act, 5 U.S.C. § 552(b)(4), 

and we request it be handled accordingly.
DocuSign Envelope ID: 7C6C4974-87A9-42E4-8711-B0834F00E87D 

Ms. Tyra Wisecup

United States Food and Drug Administration 

January 8, 2021

Page 4 of 9

With the creation of this new role, we separated our food safety processes into two 

components: Retail Food Safety and Supply Chain Food Safety. Our goal in doing this 

was to allow the newly created Vice President of Retail Food Safety position to focus 

exclusively on retail operations and the Vice President of Quality and Food Safety 

position to manage our supply chain. Our Incident Management Team, which is 

responsible for managing recalls and withdrawals, is part of the Supply Chain Food 

Safety Team; they identify corrective actions for recalls, including any at the retail level 

that are ultimately implemented by the Retail Food Safety Team, so that both teams 

coordinate to ultimately ensure food safety across all Whole Foods Market operations.

• In April 2020, we reorganized the Retail Food Safety Team so that all team members 

supporting food safety in the regional offices now report directly up to the Vice President 

of Retail Safety. This centralized all retail food safety oversight and removed direct 

regional oversight for retail food safety, in order to allow us to focus on common goals 

company-wide and create more consist retail food safety policies and processes. The 

Retail Food Safety Team includes three Senior Team Leaders, seven Area Team Leaders, 

twenty-six Field Food Safety Analysts who report to the Area Team Leaders, a Project 

Manager, a Data Analyst, and a newly created role of Documentation Manager, in order 

to continue work to drive SOP clarity, including specific procedures relating to allergen 

control.

Under this team’s leadership, we issued new and updated food safety procedures in July 

2020 to be incorporated into daily store operations for all of our retail outlets. These 

updated procedures included a “Recipe Management Policy,” which requires the 

following steps for any prepared food products in order to help reduce the risk of 

mislabeled allergen information due to error at the retail level.

o All prepared items must follow a current approved recipe, which is standardized 

and approved at a corporate level.

o Recipes must be followed precisely and accurately, which is monitored by store 

leadership.

o Any temporary recipe modifications and substitutions (typically to address an 

ingredient shortage) that would result in changes to the amount of existing 

ingredients, changes to the cooking method, or the addition or removal of 

ingredients require corporate approval, including verification of any revisions to 

the ingredient statement by the Data Operations Team.

o Production items with multi-ingredients or multi-steps, or those that require 

cooking, require a batched and printed recipe; any production items with multiingredients or multi-steps that do not have a recipe must be formally requested 

following the Data Operations Team's process, in order to obtain approval at a 

corporate level.

o All recipes must be current, accurate, printed, and organized.

Portions of this document contain Trade Secrets / Confidential Commercial Information 

exempt from disclosure under the Freedom of Information Act, 5 U.S.C. § 552(b)(4), 

and we request it be handled accordingly.
DocuSign Envelope ID: 7C6C4974-87A9-42E4-8711-B0834F00E87D 

Ms. Tyra Wisecup

United States Food and Drug Administration 

January 8, 2021

Page 5 of 9

o Any out-of-date recipes must be removed; this effort is centralized and 

communicated to individual stores weekly. 

B. Allergen Recalls Task Force

In September 2020, we established a global Allergen Recalls Task Force to help us improve 

specifically in the area of allergen recalls. This group is a cross-functional team consisting of 

Incident Management, Retail Food Safety, Culinary leadership, Legal, Team Member Services, 

Retail Operations, Data Operations, Continuous Improvement, and Regional leadership. We 

assigned this Task Force a project manager and charged it with creating various work-streams to 

further enhance food safety processes and internal systems to prevent allergen recalls. Since its 

inception this group has met regarding each Whole Foods Market allergen recall to assess the 

cause of the recall and any necessary corrective actions, and to prepare and provide reports 

regarding the recall to regional leadership. This task force is now responsible for allergen recall 

improvement efforts company-wide. 

C. Enhancing Supplier Approval Program

Our Whole Foods Market private label team (Exclusive Brands) has a well-established program 

to support supplier and product food safety for private label packaged products sold in our retail 

stores. We emulated a similar comprehensive program for regionally sourced prepared foods 

and bakery products in June 2019, as this is the category of supplier-provided products where 

we identified the most significant errors in ingredient information. The regionally sourced 

prepared foods and bakery suppliers provide us with branded products that are packed and 

labeled by the supplier and ready to be placed directly on the shelf. They also provide us with 

products intended to be transformed, repacked, or used as an ingredient within a store recipe 

and labeled with a Whole Foods Market brand.

The supplier oversight program is a centrally managed program with dedicated food safety and 

quality resources. As detailed in our Supplier Approval (Appendix B) and Supplier Facility Risk 

Assessment (Appendix C) SOPs, review of suppliers consists of a product risk assessment,

reviewing each facility’s food safety programs including supplier approval procedures, allergen 

controls, environmental monitoring, sanitation, and label control programs. Historical 

regulatory performance is taken into consideration, and a passing third-party 

Food Safety audit is required. In collaboration with business teams, supplier manufacturing 

sites are enrolled into and approved through Supplier food safety issues, including 

regulatory non-conformances, withdrawals, and recalls, trigger escalated due diligence, 

including root-cause analysis, and requirements for corrective and preventive actions. A 

decision can be made based on risk to determine if an on-site follow-up is needed to assure 

appropriate control measures have been implemented.

II. Streamlining Internal Systems and Audit Efforts to Prevent and Detect 

System Error

As background, we use a system called to host prepared food recipes, which includes 

specifications for specific ingredients to be used in each recipe. We have now established and 

implemented new processes so that the centralized Prepared Foods Team develops and 

approves recipes for all foods prepared in-house, often with input from regional teams, and 

within each recipe for a food prepared in-house is assigned a PLU code and an

Portions of this document contain Trade Secrets / Confidential Commercial Information 

exempt from disclosure under the Freedom of Information Act, 5 U.S.C. § 552(b)(4), 

and we request it be handled accordingly.

(b) (4) (b) (4) (b) (4) (b) (4)
DocuSign Envelope ID: 7C6C4974-87A9-42E4-8711-B0834F00E87D 

Ms. Tyra Wisecup

United States Food and Drug Administration 

January 8, 2021

Page 6 of 9

ingredient statement record. Ingredients can only be added to recipes in if they have 

been approved within our process, our supplier and product management system 

that houses and maintains food safety supporting information, as meeting all Whole Foods 

Market ingredient requirements that have been established by our global compliance and food 

safety teams. Once approved, our centralized purchasing teams generally coordinate ingredient 

ordering. The Data Monster Recipe Request (Appendix D) flowchart demonstrates the updated 

steps for initiating and developing a new recipe.

We use as a central location to host all nutrition information, ingredient data, and 

allergen information for ingredients we use in prepared food recipes. This information is then 

translated in in order to generate customer facing nutrition and ingredient 

information. As part of our continuous improvement efforts in food safety, in 2019 we initiated 

a comprehensive review and clean-up effort to centralize recipe data and reduce information 

managed at individual retail stores and to ensure that ingredient information is accurate and 

consistent across all of our internal systems, including , and 

One main objective of this on-going effort is to remove recipes that are no longer in use, 

primarily because the recipes did not have nutrition data verified or used ingredients that were 

not purchased through our centralized ordering system. We are doing this to reduce the amount 

of overall data in our system, which will reduce the risk of retail store employees selecting an 

incorrect recipe when generating labeling information.

We undertook this review by producing reports for each region with items that we deemed were 

misaligned and purged the affected data from all systems. Specifically, these reports identified 

ingredients that were not in the ordering system, recipes that had not yet been approved, recipes 

in that included ingredients that were not available in the purchasing system, and 

ingredients that were in the purchasing system and not attached to recipes in By 

removing this data from our system, we reduced the risk that a recipe that is not actively hosted 

in could be produced and labeled with outdated information.

Further, as part of the clean-up effort, we enhanced the gatekeeping system for new prepared 

foods purchase items within (Valid Item One-Pager, Appendix E) to ensure that we 

have up-to-date ingredients and allergens on all recipes labeled in-house. The workflow 

required the addition of a nutrition gatekeeping step to ensure purchase items were in 

 No new items for use in prepared foods can be purchased without validating 

nutrition source and updating ingredients, including allergens, in our recipe database. In 

addition, no new recipes or PLUs can be created unless all items have a valid nutrition source 

within Ultimately, this clean-up effort also identified certain products that we 

determined needed to be recalled due to inaccurate labeling information, which we believe has 

concentrated the frequency and volume of recalls into a condensed time period over the past 

year. These efforts were, and continue to be, critical in ensuring that the prepared food products 

we sell are labeled correctly.

In January 2020, we initiated a project to align all existing purchase items in our recipe 

database to a nutrition source in We began outreach to all suppliers to upload their 

ingredient information into Over the past year we have aligned over 5,000 

purchase items at the ingredient level between and We are targeting mid2021 to have all items in aligned to an ingredient record in Previously we 

did not have a renewal requirement in place, so we often were not notified by the supplier when 

a product ingredient changed. We now can automatically determine when ingredients usedin

Portions of this document contain Trade Secrets / Confidential Commercial Information 

exempt from disclosure under the Freedom of Information Act, 5 U.S.C. § 552(b)(4), 

and we request it be handled accordingly.

(b) (4) (b) (4) (b) (4)(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4)(b) (4) (b) (4) (b) (4) (b) (4) (b) (4)
DocuSign Envelope ID: 7C6C4974-87A9-42E4-8711-B0834F00E87D 

Ms. Tyra Wisecup

United States Food and Drug Administration 

January 8, 2021

Page 7 of 9

foods that we prepare in-house are updated in and update our data systems 

accordingly, through a status alert that occurs when a product record is changed. This status 

alert notifies the Compliance Team via a report that will be sent to Data Operations. Data 

Operations will use that report to assess any changes in the ingredients, including allergens.

To ensure that the streamlined system is working properly, in 2020 the Data Operations Team 

implemented a company-wide ingredient and allergen audit program. Through this audit 

program, we compare the information in each product’s recipe with the information that is 

communicated on each product label in order to verify the accuracy of ingredient information, 

including allergen information, on the product label. We will run this audit annually on every 

recipe in the database (currently approximately 55,000 recipes) as well as quarterly for new or 

seasonal products. We will run the quarterly audit before recipes are used to ensure there is a 

gate to eliminate misalignment of our recipe data system with customer facing 

ingredients/allergens. We expect that this audit program will eliminate the risk of mislabeling 

due to misalignment of data between our recipe system and customer-facing ingredient 

information.

In October 2020, we conducted the first company-wide audit, which identified a number of 

errors (primarily with recipes that are no longer in use); we corrected each of these errors, which 

included updating ingredient information as needed. We conducted a second company-wide 

audit in December 2020 and found no errors, indicating that the ingredient information that we 

provide consumers for every product we prepare in-house matches the recipes in that 

are used to prepare the products.

III. Food Safety at the Retail Level – Recipe Management, Audit, and 

Accountability

While we have extensively overhauled our food safety processes at the corporate level to help 

ensure allergen control, we believe it is equally important that such enhancements are 

implemented down to the retail store level and that our team members understand how best to 

ensure food safety, especially in regards to allergen labeling. Specifically, team members are 

required to follow various SOPs when preparing food to ensure the correct ingredients and 

ingredient labels are being used, including Recipe Execution SOP for Prepared Foods (Appendix 

F), The Daily Work List (Appendix G), Recipe Execution SOP for Bakery (Appendix H), Food 

Labeling and Identification Policy (Appendix I), and Food Safety All-in-One User Guide 

(Appendix J).

As noted above, most critically, in July 2020 we released a new Recipe Management Policy, in 

addition to new and updated food safety materials to incorporate required food safety protocols 

into daily store operations.

In addition, in order to centralize the recipe system, we eliminated the ability of individual 

stores to create their own recipes. We also established a communication escalation process for 

recipe issues, which supplements the Recipe Execution Policy and is part of the Store Process 

SOPs. For example, Team Members must execute only one recipe at a time and collect all 

ingredients prior to starting each recipe. If an ingredient is not available, then the Team 

Member must immediately notify their leadership. Leadership is only allowed to approve single 

ingredient substitutions for the same item (e.g., Roma tomatoes for cherry tomatoes). Other 

ingredient changes (including substituting a different single or multi-ingredient product) must

Portions of this document contain Trade Secrets / Confidential Commercial Information 

exempt from disclosure under the Freedom of Information Act, 5 U.S.C. § 552(b)(4), 

and we request it be handled accordingly.

(b) (4) (b) (4)
DocuSign Envelope ID: 7C6C4974-87A9-42E4-8711-B0834F00E87D 

Ms. Tyra Wisecup

United States Food and Drug Administration 

January 8, 2021

Page 8 of 9

be escalated to designated regional and global points, who then make recipe and labeling 

updates using menu and nutritional analysis software. The recipe is not made available for use 

until the new data is accurately reflected on all recipes, labels, and signs. Finally, to address 

communication between shifts, Team Members must complete an “Incomplete Production Log” 

so no one else attempts to make the recipe until the approval process has been completed.

To reinforce these systems, the Global Retail Food Safety Team assigned all store team members 

and store leadership required allergen training in October 2020, and of those assigned, more 

than 90 percent have already completed that training; the remainder are expected to complete 

the training by early this year. As part of the Allergen Job Aid SOP (Appendix K), a team lead or 

production writer will assign the label and conduct the ingredient verification process for all 

items produced and packaged in-house. A team member will verify each item made or packaged 

in-house matches the applicable ingredient information on the following:

• Product signs

• Ingredient labels

• Beauty labels

• Recipes

• Schematics/planograms

In addition, the team member will review the ingredients to make sure the following 

requirements are met:

• Allergens must be clearly identified:

o Packaged items must have the label on the packaging.

o Unpackaged items must have ingredients displayed with the product.

o Sub-ingredients must be identified [e.g. mayonnaise (expeller pressed canolaoil, 

eggs, water, honey, distilled vinegar, contains less than 2% of salt, spice, lemon 

juice concentrate)].

• Allergen information must include the name of the food source:

o Tree nuts and fish must list the specific species (e.g. Fish Stick Ingredients: Cod, 

Egg, Milk, Salt)

At that same time, we developed and released a Food Safety Self-Audit Tool for team leadership 

to reflect on their department’s practices and take active managerial control to address potential 

learning gaps. The Food Safety Self-Audit Tool directs team leadership as follows, “Pick 3 inhouse produced or packaged products and verify the PLU and ingredient list against the recipe 

used or ingredients on the package.” Retail stores that have consistently received satisfactory 

scores through this tool and through third-party audits facilitated by Everclean are required to 

perform these self-audits weekly; all other stores must perform a self-audit each day. We

Portions of this document contain Trade Secrets / Confidential Commercial Information 

exempt from disclosure under the Freedom of Information Act, 5 U.S.C. § 552(b)(4), 

and we request it be handled accordingly.
DocuSign Envelope ID: 7C6C4974-87A9-42E4-8711-B0834F00E87D 

Ms. Tyra Wisecup

United States Food and Drug Administration 

January 8, 2021

Page 9 of 9

continue to make system improvements by standardizing schematics and planograms, 

eliminating outdated recipes and PLU data, and evaluating recipe nomenclature for consistency 

across our company. Finally, we have developed a unified Food Safety Accountability Policy 

(Appendix L) addressing the responsibilities each team member must uphold to mitigate food 

safety risk as part of team member duties. This new policy went into effect this month.

* * * 

We believe we have taken significant steps in the last two years to streamline and enhance our 

food safety processes. As we continue to further enhance these processes and accountability 

mechanisms, we expect to see a reduction in undeclared allergens recalls. By centralizing the 

system at the corporate level, we have created uniform policies and action items across all our 

retail stores. With the enhancement to our internal systems and supplier programs, we are 

confident we will reduce the opportunities for undeclared allergens and mislabeling. Finally, 

with the Corporate Food Safety Team working directly with regional and store team leadership 

to take corrective actions, we hope to foster an environment that empowers food safety at the 

retail level. We will continue to monitor our processes and procedures through our audit 

program and will assess if any additional actions are needed in the future.

Please do not hesitate to contact Alicia White at alicia.white@wholefoods.com if you have any 

questions about any of the above. We look forward to the opportunity to discuss our efforts 

further with you at your convenience.

Best Regards,

Jason J. Buechel

Chief Operating Officer

Portions of this document contain Trade Secrets / Confidential Commercial Information 

exempt from disclosure under the Freedom of Information Act, 5 U.S.C. § 552(b)(4), 

and we request it be handled accordingly.
Recalls 13.5 

Home 

Event ID: 86836 Status: Ongoing Updated: 12/11/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 86836 RFR EON ID 

Recall Number(s) F-0168-2021 RFR EON URLs 

District Human And Animal Food West V Coordinator Rochelle Blair 

Firm Awareness Date 11/22/2020 District Awareness Date 11/23/2020 

Center (Int) Center for Food Safety and 

Applied Nutrition 

Coordinator 

Leonara K Darlington 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 3007331558 Name (Int) Whole Foods Market 

Responsible Firm FEI 3007331558 Name Whole Foods Market 

Public Reason for Recall Undeclared allergen (shrimp) due to product mislabeling. 

Edit Mode Viewable Recall Status (Int) Ongoing 

Voluntary/Mandated (Int) Firm Initiated Date (Int) 11/22/2020 

Firm Recommended Recall Depth Consumers/User Date Distribution Chain Notified 11/23/2020 

Recall Initiation Date (Int) 11/23/2020 Firm Initial Notification E-Mail 

Determination Date 12/10/2020 Center Coordinator Assigned Date 12/02/2020 

Classification Date 12/10/2020 FDA Sample Number None 
Complete Reason for Recall Undeclared allergen (shrimp) due to product mislabeling; product was labeled Popcorn Chicken with Sweet 

Chili when it actually contained popcorn shrimp. The firm was alert to the issue by a customer who had an 

allergic reaction. 

Root Cause Other 

Root Cause Narrative Incorrect PLU number was provided to the stores, and therefore when product was repacked into retail sized 

containers at the store level the incorrect label was placed on it. 

Center Comments Class I, CFSAN concurs with audit check strategy. 

Type Of Injury The firm received one consumer report of illness/injury and one complain regarding product defect. 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees 

Number of Foreign Consignees 0 

Distributed From 11/05/2020To 11/22/2020 

Distribution Pattern (Int) U.S distribution to the following: CA and NV. No foreign distribution. 

Manufactured From 11/05/2020To 11/22/2020 

Public Summary of Recall Strategy 

(Int)

On 11/22/20 an email went out to all stores across the region. Stores were instructed to check the fresh 

pack to ensure that Popcorn Chicken Shaker with Sweet Chili (PLU #81789) does not contain Sweet Chili 

Popcorn Shrimp. Stores were told to pull and destroy any packages of Popcorn Chicken Shaker with Sweet 

Chili that contains Popcorn Shrimp, and report quantities in their system. The firm issued a press release on 

11/23/20. 

Recall Strategy On 11/22/20 an email through their system to all stores across the region (48 stores). Stores 

were instructed to pull and destroy the effected product. The firm also removed the PLU code from their 

system so it would no longer scan at checkout. The firm issued a press release on 11/23/20. The firm ran a 

movement report in their inventory system to show which stores had showed movement against the PLU, the 

stores that showed movement were included in the press release. 

Effectiveness Check Level APercent 100 

Audit Check Level BPercent 20 

Audit/Effectiveness Check 

Modification 

RAC Assignment Date Issued 12/01/2020 RAC Assignment Date Completed 12/11/2020 

District RAC Assignment Needed? 

Yes 

District Justification for No Audit 

Check 

District Recommendation for No 

Audit Check Comments 

Center Agrees with District RAC 

Assignment Recommendation 

Yes 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

Center Recommendation 

Justification Comments 

Center Entering Recall 

What Consumers Should Do (Int)

(b) (4) (b) (4) (b) (4) (b) (4)
Expanded Comments for 

What Consumers Should Do (Int)

Firm Press Issued (Int) 11/23/2020 URL (Int) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alertissued-undeclared-shrimp-mislabeled-popcorn-chicken-26-whole-foods-market-stores 

State Press Issued (Int) URL (Int) 

FDA Press Issued (Int) URL (Int) 

Additional Medical Product 

Information (Int)

URL (Int) 

Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

No foreign consignees. No VA consignees. No DoD consignees. 

Consignees Approx. Number Consignees Approx. Number

Distributor 0 Repacker/Relabeler 0 

Retailer Direct Accounts 0

Institution 0 Veterans Administration 0

Medical Facility 0 Department of Defense 0 

Internet Sales 0 Manufacturer 0

Physician 0 USDA 0

Consumer/Patient 0 Other 0 

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

Product Disposition 

Number of Consignees Responding 

to Notification 

Effectiveness Check Information 

Recall Audit Check Count Audit Count Summary : Not Available 

Audit Check Information 

Section of Law Violated 

Preventive Action Taken by Firm 

District Follow-Up 

District Review 

Legal Action 

(b) (4)
Class I Termination 

Recommendation 

Recommended/Prepared By 

District Management Approval Date 

Center Concurrence 

Recall Completed Date 

Termination Letter Date 

CFSAN Center Information

Docs Rcvd at Ctr Date 

HHE Sent 

HHE Signed 

HHE Precedent 

Outbreak Associated N 

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 16-KGT05

Precedent Recall P-7951 

Precedent Policy 

Precedent Policy Comment

Product Description (Int)

(Label/Packaging)

Whole Foods Market Popcorn Chicken Shaker with Sweet Chili Variable weight sold by lb. 

Packed For Whole Foods Market 

Trade Name (Int)

Generic Name (Int)

Product Usage Ready-to-eat for human consumption. 

Product Quantity Distributed (Int)

Recall Number (Int) F-0168-2021 

Product Public Reason for Recall (Int) Undeclared allergen (shrimp) due to product mislabeling. 

Field Recommended Classification Class I 

Center Determination/Classification (Int) Class I 

Center Recommended Depth Consumers/User 

Product Effectiveness Check Level A Percent 100 

Product Audit Check Level B Percent 20 

Code Information (Int) PLU number 81789 Sell by dates through November 27, 2020 

Expected Life 

Shelf Life 

(b) (4)
CFSAN Reason Labeling/undeclared allergen 

Recalling Firm Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title CEO 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address john.mackey@wholefoods.com

Comment 

Manufacturer Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Responsible Firm Information
FEI 3007331558 

Firm Type Manufacturer 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Recall Contact

Official's Name Deirdre Dillon 

Title Senior Food Safety Analysist 

Firm Name (Int) Whole Foods Market 

Address (Int) 6401 Hollis St. 

Ste. 150 

City (Int) Emeryville

State/Province (Int) California 

Country (Int) United States 

Postal Code (Int) 94608 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address Deirdre.Dillon@wholefoods.com

Comment 

Public Contact

Official's Name Rachel Malish 

Title Communications 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address Rachel.malish@wholefoods.com
Comment 

Summary Help 

WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 

Printed by: Tyra S. Wisecup 

Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration 
Recalls 13.5 

Home 

Event ID: 84020 Status: Terminated Updated: 01/17/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 84020 RFR EON ID 

Recall Number(s) F-0131-2020 RFR EON URLs 

District Human And Animal Food West III Coordinator Casey Hamblin 

Firm Awareness Date 10/09/2019 District Awareness Date 10/09/2019 

Center (Int) Center for Food Safety and 

Applied Nutrition 

Coordinator 

Dehlia Young 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 3012452762 Name (Int) H&F Bread Co LLC 

Responsible Firm FEI 3007331558 Name Whole Foods Market 

Public Reason for Recall Undeclared milk and eggs 

Edit Mode Viewable Recall Status (Int) Terminated 

Voluntary/Mandated (Int) Firm Initiated Date (Int) 10/09/2019 

Firm Recommended Recall Depth Consumers/User Date Distribution Chain Notified 10/09/2019 

Recall Initiation Date (Int) 10/09/2019 Firm Initial Notification Combination

Determination Date 11/07/2019 Center Coordinator Assigned Date 10/31/2019 

Classification Date 11/07/2019 FDA Sample Number None 
Complete Reason for Recall The retail store employees would previously apply a PLU label to the recalled rolls as they came in 

unlabeled. The manufactured then changed its operations and began providing UPC labeled units for retail 

sale. The employees used the previous procedure and continued to "overlabel" the recalled rolls with the PLU 

labels that did not list the milk and eggs in the ingredient statement. 

Root Cause Other 

Root Cause Narrative Employees placed a label over the manufacturers label. The Whole Foods Market label failed to declare milk 

and egg. 

Center Comments Class I. CFSAN concurs with audit check strategy. 

Type Of Injury None reported 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees 

Number of Foreign Consignees 0 

Distributed From 9/23/2019To 10/8/2019 

Distribution Pattern (Int) Michigan, Wisconsin, Illinois 

Manufactured From 9/23/2019To 10/8/2019 

Public Summary of Recall Strategy 

(Int)

The recalling firm issued press on 10/9/19. Affected stores were notified via the online recall notification 

system on 10/9/19 as well. 

Recall Strategy The recalling firm issued press on 10/9/19. Affected stores were notified via the online recall notification 

system on 10/9/19 as well. 

Effectiveness Check Level APercent 100 

Audit Check Level APercent 100 

Audit/Effectiveness Check 

Modification 

RAC Assignment Date Issued 10/23/2019 RAC Assignment Date Completed 11/15/2019 

District RAC Assignment Needed? 

Yes 

District Justification for No Audit 

Check 

District Recommendation for No 

Audit Check Comments 

Center Agrees with District RAC 

Assignment Recommendation 

Yes 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

Center Recommendation 

Justification Comments 

Center Entering Recall 

What Consumers Should Do (Int)

Expanded Comments for 

What Consumers Should Do (Int)

Firm Press Issued (Int) 10/10/2019 URL (Int) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alertundeclared-milk-egg-white-parkerhouse-rolls-issued-four-whole-foods-market-stores 

(b) (4) (b) (4) (b) (4)
State Press Issued (Int) URL (Int) 

FDA Press Issued (Int) URL (Int) 

Additional Medical Product 

Information (Int)

URL (Int) 

Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

Consignees Approx. Number Consignees Approx. Number 

Distributor 0 Repacker/Relabeler 0

Retailer Direct Accounts 0

Institution 0 Veterans Administration 0 

Medical Facility 0 Department of Defense 0

Internet Sales 0 Manufacturer 0

Physician 0 USDA 0

Consumer/Patient 0 Other 0

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

None 

Product Disposition Product was pulled and PLU labels were removed 

Number of Consignees Responding

to Notification 

retail stores 

Effectiveness Check Information 4/4 = 100% 

Recall Audit Check Count Audit Count Summary : Not Available 

Audit Check Information Four recall audit checks were conducted for this recall. All 3177s were endorsed as effective. 

Section of Law Violated Section 402(a)(1) of the Food, Drug and Cosmetic Act 

Preventive Action Taken by Firm Verify previously used PLUs are deactivated before introducing a product containing a UPC. 

District Follow-Up None planned. The issue occurred at the retail level. 

District Review A review of the recall file and 3177s was completed during evaluation of this recall. The recall appears to be 

complete and effective. 

Legal Action None planned (b) (4)

(b) (4)

(b) (4)
Class I Termination 

Recommendation 

DRC recommends termination of this recall. 

Recommended/Prepared By Casey Hamblin 

District Management Approval Jessica Havranek, DCB Date 01/09/2020 

Center Concurrence Angela Alexander 

Recall Completed Date 10/09/2019 

Termination Letter Date 01/17/2020 

CFSAN Center Information

Docs Rcvd at Ctr Date 10/29/2019 

HHE Sent 

HHE Signed 

HHE Precedent P-7907, P-7968 

Outbreak Associated N 

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 03-Y99 

Precedent Recall P-7907, P-7968 

Precedent Policy 

Precedent Policy Comment The level of risk to health posed by the violative product is similar to the level or risk previously 

evaluated in the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market White Parkerhouse Rolls PLU 49557 NET WT. 0 lb 12 oz (340g) packaged 

in a clear plastic bag 12 rolls per bag 

Trade Name (Int) Whole Foods Market 

Generic Name (Int)

Product Usage Food for human consumption 

Product Quantity Distributed (Int)

Recall Number (Int) F-0131-2020 

Product Public Reason for Recall (Int) Undeclared milk and eggs 

Field Recommended Classification Class I 

Center Determination/Classification (Int) Class I 

Center Recommended Depth Consumers/User 

Product Effectiveness Check Level A Percent 100 

Product Audit Check Level A Percent 100 

Code Information (Int) PLU 49557 all lots within date 

Expected Life 

(b) (4)
Shelf Life 10/13/19 

CFSAN Reason Labeling/undeclared allergen 

Recalling Firm Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title President/CEO 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address 

Comment 

Manufacturer Information

FEI 3012452762 

Firm Name (Int) H&F Bread Co LLC 

Address (Int) 1500 Marietta Blvd NW 

City (Int) Atlanta 

State/Province (Int) Georgia 

Country (Int) United States 

Postal Code (Int) 30318-3643 

Telephone 404-3508877 Ext Country Code

Comment 
Responsible Firm Information

FEI 3007331558 

Firm Type Relabeler 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Recall Contact

Official's Name Craig Penigar 

Title Global Quality Assurance 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 512-831-8372 Ext Country Code

Facsimile Ext Country Code

E-mail Address 

Comment 

Public Contact

Official's Name 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address 
Comment Contact: Olivia Petersen, oliviapetersen@wholefoods.com; Consumers with additional questions can call 1- 

844-936-8255 between the hours of 7:00 a.m. and 10:00 p.m. CST, Monday through Friday, or 8:00 a.m. and 

6:00 p.m. Saturday through Sunday. 

Summary Help 

WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 

Printed by: Tyra S. Wisecup 

Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration 
Recalls 13.5 

Home 

Event ID: 84345 Status: Terminated Updated: 01/13/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 84345 RFR EON ID 

Recall Number(s) F-0408-2020 RFR EON URLs 

District Human And Animal Food West III Coordinator Casey Hamblin 

Firm Awareness Date 11/21/2019 District Awareness Date 11/21/2019 

Center (Int) Center for Food Safety and 

Applied Nutrition 

Coordinator 

Melanie Butler 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 3015252759 Name (Int) EMILIA FOODS SRL 

Responsible Firm FEI 3015252759 Name EMILIA FOODS SRL 

Public Reason for Recall Undeclared egg 

Edit Mode Viewable Recall Status (Int) Terminated 

Voluntary/Mandated (Int) Firm Initiated Date (Int) 11/22/2019 

Firm Recommended Recall Depth Consumers/User Date Distribution Chain Notified 11/22/2019 

Recall Initiation Date (Int) 11/22/2019 Firm Initial Notification Combination

Determination Date 12/12/2019 Center Coordinator Assigned Date 12/10/2019 

Classification Date 12/19/2019 FDA Sample Number None 
Complete Reason for Recall It was reported to WFM that a pint of Raspberry Cheesecake Italian Gelato was on the shelf in the West 

Loop WFM store in the Midwest region and inside the pint it appeared to contain the WFM Butter Cookies & 

Sweet Cream Gelato, as it was stocked with the Butter Cookies & Sweet Cream Gelato. The manufacturer is 

in Modena, Italy and produces both of these products that launched this summer. Allergens were cross 

checked for these two items and it was found that the WFM Butter Cookies & Sweet Cream Italian Gelato 

contains: Tree nuts (coconut), Milk, Wheat, and Eggs while the WFM Raspberry Cheesecake Italian Gelato 

declares: Tree nuts (coconut), Milk, Wheat. Leading to undeclared egg in the one pint that was discovered to 

be mislabeled. 

Root Cause Other 

Root Cause Narrative The pint labeled as Raspberry Cheesecake Italian Gelato SKU has been mistakenly placed in the case 

containing the pints of Butter Cookies and Sweet Cream Italian Gelato SKU by the pints suppliers personnel. 

The mistake occurred because of a lack of controls at the beginning and at the end of packaging production. 

The random intake check control decided that the packaging product was conforming with the specs. Further 

random check controls before the finished product production start was also indicating that the pack was 

conform with the specs. Even the final control to the finished product made before pints are placed in the 

case did not produce evidence of mislabeling pints. 

Center Comments Class II. CFSAN concurs with audit check strategy. 

Type Of Injury None reported 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees

Number of Foreign Consignees 0 

Distributed From To

Distribution Pattern (Int) Nationwide 

Manufactured From 06/03/2019To 06/19/2019 

Public Summary of Recall Strategy 

(Int)

The firm made the decision to recall on 11/21-22/19. A press release was sent out on 11/22/19. The affected 

consignees were notified via email beginning on 11/22/19. 

Recall Strategy The firm made the decision to recall on 11/21-22/19. Consignees were notified via emails to the stores 

affected through our recall management tool, and email to UNFI for the official notice on 11/22/19. 

Effectiveness Check Level APercent 100 

Audit Check Level MPercent 0 

Audit/Effectiveness Check 

Modification 

RAC will be assigned per OSPOP recall guidance doc 

RAC Assignment Date Issued 12/11/2019 RAC Assignment Date Completed 12/26/2019 

District RAC Assignment Needed? 

Yes 

District Justification for No Audit 

Check 

District Recommendation for No 

Audit Check Comments 

Center Agrees with District RAC 

Assignment Recommendation 

Yes 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

(b) (4) (b) (4) (b) (4) (b) (4)
Center Recommendation 

Justification Comments 

Center Entering Recall 

What Consumers Should Do (Int)

Expanded Comments for 

What Consumers Should Do (Int)

Firm Press Issued (Int) 11/22/2019 URL (Int) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alertissued-due-undeclared-egg-whole-foods-market-brand-raspberry-cheesecake-italian-gelato 

State Press Issued (Int) URL (Int) 

FDA Press Issued (Int) URL (Int) 

Additional Medical Product 

Information (Int)

URL (Int) 

Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

1 distribution company, (distributor) then to 

 No VA/DOD/Foreign consignees 

Consignees Approx. Number Consignees Approx. Number

Distributor Repacker/Relabeler 0

Retailer Direct Accounts 0

Institution 0 Veterans Administration 0

Medical Facility 0 Department of Defense 0

Internet Sales 0 Manufacturer 0

Physician 0 USDA 0

Consumer/Patient 0 Other 0

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

 from Whole Foods Market Stores 

Product Disposition Destroyed. No CODs are available from stores. 

Number of Consignees Responding 

to Notification 

1 distribution company, (distributor) then to all responded to the 

recall. 

Effectiveness Check Information 100% 

Recall Audit Check Count Audit Count Summary : Not Available 

(b) (4)

(b) (4)

(b) (4) (b) (4) (b) (4) (b) (4) (b) (4)
Audit Check Information 25 EFFECTIVE 4 INEFFECTIVE BY RECALLING FIRM 1 COULD NOT BE DETERMINED. Some of the 

affected product was see for sale on the retail shelves. Per the recalling firm, "We have received notice that 

FDA officials are finding the recalled pints of the WFM Raspberry Gelato with best by date JUN 11 2021. The 

reason this product is being found on shelves now is because all of our stores completed the recall and 

removed any possible affected product on shelf. Separate instructions were given to DCs and that was to 

remove and destroy all master cases of the WFM Butter Cookies & Sweet Cream Italian Gelato (bb JUN 11 

2021) because the misfiled product would have been packed with the Butter Cookies Gelato. The product that 

stores are now carrying in store is correctly labeled and unaffected." 

Section of Law Violated Section 402 of the Food, Drug and Cosmetic Act 

Preventive Action Taken by Firm Specific training will be provided to the packaging suppliers personnel highlighting all rules and procedures 

that must be followed during a change of SKU. Registration modules will be introduced to give evidence of 

SKU change: in this module the change of SKU will be verified and it will be signed by person Responsible for 

that control. In the gelato manufacturing facility will be placed a further training to the relevant operatives and 

supervisors. The number of controls during the whole production process will be implemented. QA Emilia 

Foods will be present for production controls at least once a month at the gelato manufacturing facility. The 

personnel of gelato manufacturing facility will verify that every single pint corresponds to the SKU starting 

from the ongoing production to the end of the production; at the end of every production all the remaining 

packaging must be removed. Moreover the personnel at the end of the cooling tunnel will verify that all the 

pints are corresponding to the on going production and they will also check the matching between the 

produced pints and the carton label of the finished product. 

District Follow-Up No follow-up is planned by the division. The responsible firm will be inspected at the discretion of CFSAN. 

District Review A review of the recall file, mfrs CAPA and RACs was completed during evaluation of this recall. The recall 

appears to be complete and effective. 

Legal Action None planned. 

Class I Termination 

Recommendation 

Recommended/Prepared By Casey Hamblin 

District Management Approval Jessica Havranek, DCB Date 01/10/2020 

Center Concurrence

Recall Completed Date 11/22/2019 

Termination Letter Date 01/13/2020 

CFSAN Center Information

Docs Rcvd at Ctr Date 12/09/2019 

HHE Sent 12/12/2019 

HHE Signed 12/19/2019 

HHE Precedent 10293 

Outbreak Associated N 

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 13-AGT03
Precedent Recall 10293 

Precedent Policy 

Precedent Policy Comment

Product Description (Int)

(Label/Packaging)

Whole Foods Market Raspberry Cheesecake Italian Gelato 1 Pint (473mL) UPC 9948248024 

packaged in a clear plastic container 

Trade Name (Int) Whole Foods Market 

Generic Name (Int)

Product Usage Food for human consumption 

Product Quantity Distributed (Int)

Recall Number (Int) F-0408-2020 

Product Public Reason for Recall (Int) Undeclared egg 

Field Recommended Classification Class I 

Center Determination/Classification (Int) Class II 

Center Recommended Depth Consumers/User 

Product Effectiveness Check Level A Percent 100 

Product Audit Check Level M Percent 0 

Code Information (Int) L.P. JUN/11/19 E. JUN/11/21 A103-1 

Expected Life 

Shelf Life 6/11/2021 

CFSAN Reason Labeling/undeclared allergen 

Recalling Firm Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title CEO 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

(b) (4)
City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address 

Comment 

Manufacturer Information

FEI 3015252759 

Firm Name (Int) EMILIA FOODS SRL 

Address (Int) Via Emilia Est 903 

City (Int) Modena 

State/Province (Int)

Country (Int) Italy 

Postal Code (Int)

Telephone Ext Country Code

Comment 

Responsible Firm Information

FEI 3015252759 

Firm Type Manufacturer 

Firm Name (Int) EMILIA FOODS SRL 

Address (Int) Via Emilia Est 903 

City (Int) Modena 

State/Province (Int)

Country (Int) Italy 

Postal Code (Int)

Telephone Ext Country Code

Comment 

Recall Contact

Official's Name Ashley Dia Zuaiter 

Title Quality Assurance Incident Analyst 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 
Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address ashley.zuaiter@wholefoods.com

Comment Office: 512 542-0426 Cell: 512-815-5701 

Public Contact

Official's Name 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address 

Comment Betsy.Harden@wholefoods.com 512.542.3198

Summary Help 

WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 

Printed by: Tyra S. Wisecup 

Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration 
Recalls 13.5 

Home 

Event ID: 84888 Status: Terminated Updated: 04/07/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 84888 RFR EON ID 

Recall Number(s) F-0764-2020 F-0765-2020 F 

-0766-2020 F-0767-2020 

RFR EON URLs 

District Human And Animal Food West III Coordinator Casey Hamblin 

Firm Awareness Date 02/04/2020 District Awareness Date 02/04/2020 

Center (Int) Center for Food Safety and 

Applied Nutrition 

Coordinator 

Leonara K Darlington 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 3007331558 Name (Int) Whole Foods Market 

Responsible Firm FEI 3007331558 Name Whole Foods Market 

Public Reason for Recall Undeclared milk 

Edit Mode Viewable Recall Status (Int) Terminated 

Voluntary/Mandated (Int) Firm Initiated Date (Int) 02/04/2020 

Firm Recommended Recall Depth Consumers/User Date Distribution Chain Notified 02/04/2020 

Recall Initiation Date (Int) 02/04/2020 Firm Initial Notification Combination

Determination Date 03/02/2020 Center Coordinator Assigned Date 02/18/2020 

Classification Date 03/02/2020 FDA Sample Number None 

Complete Reason for Recall Undeclared milk due to an internal label error. Milk declaration was not included on the initial label creation. 
Root Cause Other 

Root Cause Narrative Internal labeling error discovered through a label inspection. 

Center Comments Class I, CFSAN concurs with audit check strategy. 

Type Of Injury No allergic reactions have been reported to date. 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees

Number of Foreign Consignees 0 

Distributed From 02/03/2020To 02/03/2020 

Distribution Pattern (Int) Kentucky, Maryland, New Jersey, Pennsylvania, Ohio, Virginia and Washington D.C. 

Manufactured From 02/03/2020To 02/03/2020 

Public Summary of Recall Strategy 

(Int)

The recalling firm issued a press release on 2/4/2020. The affected retail stores were notified of the recall 

electronically on 2/4/2020 via an internal recall system. 

Recall Strategy The recalling firm issued a press release on 2/4/2020. The affected retail stores were notified of the recall

electronically on 2/4/2020 via an internal recall system. Notified stores must confirm theyve completed the 

recall online. 

Effectiveness Check Level APercent 100 

Audit Check Level EPercent 0 

Audit/Effectiveness Check 

Modification 

RAC Assignment Date Issued RAC Assignment Date Completed 

District RAC Assignment Needed? 

No 

District Justification for No Audit 

Check 

Firm has history of effective audit 

checks

District Recommendation for No 

Audit Check Comments 

Firm has a very extensive history 

of effective recalls. The firm has an 

effective in house recall monitoring 

system. The root cause was an 

internal label printing error. 

Center Agrees with District RAC 

Assignment Recommendation 

Yes 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

Center Recommendation 

Justification Comments 

Center Entering Recall 

What Consumers Should Do (Int)

Expanded Comments for 

What Consumers Should Do (Int)

Firm Press Issued (Int) 02/04/2020 URL (Int) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alertissued-undeclared-milk-bundt-cake-and-chocolate-dipped-cookies-sold-44-whole-foods 

State Press Issued (Int) URL (Int) 

(b) (4) (b) (4) (b) (4)
FDA Press Issued (Int) URL (Int) 

Additional Medical Product 

Information (Int)

URL (Int) 

Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

. No 

Foreign/DOD/VA consignees 

Consignees Approx. Number Consignees Approx. Number

Distributor 0 Repacker/Relabeler 0 

Retailer Direct Accounts 0

Institution 0 Veterans Administration 0

Medical Facility 0 Department of Defense 0 

Internet Sales 0 Manufacturer 0

Physician 0 USDA 0

Consumer/Patient 0 Other 0 

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

cases, 

Product Disposition The recalled product was destroyed 

Number of Consignees Responding 

to Notification 

consignees 

Effectiveness Check Information 44/44 = 100% 

Recall Audit Check Count Audit Count Summary : Not Available 

Audit Check Information No recall audit checks were done for this recall. The firm has a history of effective recalls using their FoodiQ 

system.

Section of Law Violated Section 402(a)(1) of the Food, Drug and Cosmetic Act 

Preventive Action Taken by Firm Labels are being audited at the Global and store locations prior to product deployment 

District Follow-Up The issue was an internal label error by Whole Foods Market. No manufacturing location was implicated 

therefore no follow-up will be conducted outside of this recall. 

District Review A review of the recall file was conducted during evaluation of this recall. The recall appears to be complete 

and effective. 

Legal Action None planned. 

Class I Termination 

Recommendation 

DRC is recommending termination concurrence. 

Recommended/Prepared By Casey Hamblin 

(b) (4) (b) (4)

(b) (4)

(b) (4)

(b) (4)
District Management Approval Chad Whitwell, ADCB Date 04/06/2020 

Center Concurrence Angela Alexander 

Recall Completed Date 02/04/2020 

Termination Letter Date 

CFSAN Center Information

Docs Rcvd at Ctr Date 02/18/2020 

HHE Sent 

HHE Signed 

HHE Precedent P-7907 

Outbreak Associated N 

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 03-R02 

Precedent Recall P-7907 

Precedent Policy 

Precedent Policy Comment The level of risk to health posed by the violative product is similar to the level or risk previously 

evaluated in the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Chocolate Fudge Mini Bundt Cake sold by the slice packaged in Self Serve and Plastic clam 

shell containers PLU 21287 

Trade Name (Int) Whole Foods Market 

Generic Name (Int)

Product Usage Food for human consumption 

Product Quantity Distributed (Int) (total) 

Recall Number (Int) F-0764-2020 

Product Public Reason for Recall (Int) Undeclared milk 

Field Recommended Classification Class I 

Center Determination/Classification (Int) Class I 

Center Recommended Depth Consumers/User 

Product Effectiveness Check Level A Percent 100 

Product Audit Check Level E Percent 0 

Code Information (Int) Best by Dates Through Feb 08 2020 

Expected Life 

Shelf Life 2/8/2020 

CFSAN Reason Labeling/undeclared allergen 

Product : 2 Industry-Product Code

(b) (4)
03-R02 Precedent Recall 

P-7907 Precedent Policy 

Precedent Policy Comment 

The level of risk to health posed by the violative product is similar to the level or risk previously evaluated in 

the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Marble Bundt Cake sold by the slice packaged in Self Serve and Plastic clam shell containers PLU 45162 Trade Name (Int)

Whole Foods Market Generic Name (Int)

Product Usage 

Food for human consumption Product Quantity Distributed (Int)

 (total) Recall Number (Int)

F-0765-2020 

Product Public Reason for Recall 

(Int)

Undeclared milk Field Recommended Classification 

Class I 

Center Determination/Classification

(Int)

Class I Center Recommended Depth 

Consumers/User Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Best by Dates Through Feb 08 2020 Expected Life 

Shelf Life 

2/8/2020 CFSAN Reason 

Product : 3 Industry-Product Code

03-H02 Precedent Recall 

P-7907 Precedent Policy 

Precedent Policy Comment 

The level of risk to health posed by the violative product is similar to the level or risk previously evaluated in 

the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Dark Chocolate Dipped Almond Horn Cookie sold by the individual cookie packaged in Self Serve and 

Plastic clam shell containers PLU 33579 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

Product Usage 

Food for human consumption Product Quantity Distributed (Int)

 (total) Recall Number (Int)

F-0766-2020 

Product Public Reason for Recall 

(Int)

(b) (4) (b) (4)
Undeclared milk Field Recommended Classification 

Class I 

Center Determination/Classification

(Int)

Class I Center Recommended Depth 

Consumers/User Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Best by Dates Through Feb 17 2020 Expected Life 

Shelf Life 

2/17/2020 CFSAN Reason 

Product : 4 Industry-Product Code

03- H02 Precedent Recall 

P-7907 Precedent Policy 

Precedent Policy Comment 

The level of risk to health posed by the violative product is similar to the level or risk previously evaluated in 

the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Chocolate Dipped Coconut Macaroon Cookie sold by the individual cookie packaged in Self Serve and 

Plastic clam shell containers PLU 48454 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

Product Usage 

Food for human consumption Product Quantity Distributed (Int)

 (total) Recall Number (Int)

F-0767-2020 

Product Public Reason for Recall 

(Int)

Undeclared milk Field Recommended Classification 

Class I 

Center Determination/Classification

(Int)

Class I Center Recommended Depth 

Consumers/User Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Best by Dates Through Feb 8 2020 Expected Life 

Shelf Life 

2/8/2020 CFSAN Reason 

Recalling Firm Information

FEI 3007331558 

(b) (4)
Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title President/CEO 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 512-542-2200 Ext Country Code

Facsimile Ext Country Code

E-mail Address 

Comment 

Manufacturer Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Responsible Firm Information

FEI 3007331558 

Firm Type Manufacturer 

Firm Name (Int) Whole Foods Market 
Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Recall Contact

Official's Name Craig Penigar 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address 

Comment 

Public Contact

Official's Name 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address 

Comment Rachel Malish Rachel.Malish@wholefoods.com

Summary Help 
WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 

Printed by: Tyra S. Wisecup 

Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration 
Recalls 13.5 

Home 

Event ID: 85135 Status: Terminated Updated: 04/07/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 85135 RFR EON ID 

Recall Number(s) F-0846-2020 RFR EON URLs 

District Human And Animal Food West III Coordinator Casey Hamblin 

Firm Awareness Date 03/01/2020 District Awareness Date 03/02/2020 

Center (Int) Center for Food Safety and 

Applied Nutrition 

Coordinator 

Angela Alexander 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 3007331558 Name (Int) Whole Foods Market 

Responsible Firm FEI 3007331558 Name Whole Foods Market 

Public Reason for Recall Contains undeclared milk 

Edit Mode Viewable Recall Status (Int) Terminated 

Voluntary/Mandated (Int) Firm Initiated Date (Int) 03/02/2020 

Firm Recommended Recall Depth Consumers/User Date Distribution Chain Notified 03/02/2020 

Recall Initiation Date (Int) 03/02/2020 Firm Initial Notification Other 

Determination Date 03/20/2020 Center Coordinator Assigned Date 03/18/2020 

Classification Date 03/20/2020 FDA Sample Number None 
Complete Reason for Recall The recalling firm noticed that the product label did not declare a missing allergen, Milk. Supplier uploaded a 

spec sheet with an ingredient statement that added a MILK allergen to item identified by the manufacturer as 

item 1362-3. The previous spec sheet with the same manufacturer item number did not contain MILK. 

Root Cause Other 

Root Cause Narrative Supplier changed ingredient statements on product without confirming with WFM of the change. 

Center Comments Class I. CFSAN concurs with audit check strategy. 

Type Of Injury None reported 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees 

Number of Foreign Consignees 0 

Distributed From 02/28/2020To 03/02/2020 

Distribution Pattern (Int) Alabama, Arizona, California, Colorado, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, 

Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Mexico, North Carolina, South Carolina, 

Tennessee, Texas, Utah and Wisconsin. 

Manufactured From 02/28/2020To 03/01/2020 

Public Summary of Recall Strategy 

(Int)

A press release was issued on 3/3/2020. The recalling firm notified their affected stores via online platform 

on 3/2/2020. 

Recall Strategy The recalling firm used the and online platform used to communicate with the affected stores on 

3/2/2020. A press release was issued on 3/3/2020. Our retail stores acknowledge the receipt of the recall 

communication and close out once quantities, if any are tallied. 

Effectiveness Check Level APercent 100 

Audit Check Level EPercent 0 

Audit/Effectiveness Check 

Modification 

The issue occurred in WFM stores, not at a manufacturing facility. WFM in store recall system has a history 

of facilitating effective recalls. 

RAC Assignment Date Issued RAC Assignment Date Completed 

District RAC Assignment Needed? 

No 

District Justification for No Audit 

Check 

Due to firm's past history of 

successful recall strategy and 

effectiveness checks, RACs not 

needed 

District Recommendation for No 

Audit Check Comments 

Additionally, the issue occurred in 

WFM stores, not at a 

manufacturing facility. WFM in 

store recall system has a history of 

facilitating effective recalls. 

Center Agrees with District RAC 

Assignment Recommendation 

Yes 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

Center Recommendation 

Justification Comments 

Center Entering Recall 

(b) (4) (b) (4) (b) (4) (b) (4)
What Consumers Should Do (Int)

Expanded Comments for 

What Consumers Should Do (Int)

Firm Press Issued (Int) 03/03/2020 URL (Int) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alertissued-undeclared-milk-green-chile-chicken-tamales-sold-whole-foods-market-stores 

State Press Issued (Int) URL (Int) 

FDA Press Issued (Int) URL (Int) 

Additional Medical Product 

Information (Int)

URL (Int) 

Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

Consignees Approx. Number Consignees Approx. Number 

Distributor 0 Repacker/Relabeler 0

Retailer Direct Accounts 0

Institution 0 Veterans Administration 0 

Medical Facility 0 Department of Defense 0

Internet Sales 0 Manufacturer 0

Physician 0 USDA 0

Consumer/Patient 0 Other 0

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

 cases, 

Product Disposition The affected product was destroyed. 

Number of Consignees Responding 

to Notification 

 retail locations 

Effectiveness Check Information 204/204 = 100% 

Recall Audit Check Count Audit Count Summary : Not Available 

Audit Check Information NO RACs were performed for this recall. The firm has a history of performing effective recalls. 

Section of Law Violated Section 402(a)(1) of the Food, Drug and Cosmetic Act

Preventive Action Taken by Firm Whole Foods Market has instructed the supplier to inform the firm when product spec sheets are 

updated/changed. 

District Follow-Up The issue occurred at Whole Foods Market retail stores, therefore no follow-up is planned by HAFW3. 

(b) (4) (b) (4) (b) (4) (b) (4) (b) (4)
District Review A review of the recall file and termination information was completed during evaluation of this recall. The 

recall appears to be complete and effective. 

Legal Action None planned. 

Class I Termination 

Recommendation 

DRC recommends termination concurrence. 

Recommended/Prepared By Casey Hamblin 

District Management Approval Chad Whitwell, ADCB Date 04/06/2020 

Center Concurrence Angela Alexander 

Recall Completed Date 03/02/2020 

Termination Letter Date 

CFSAN Center Information

Docs Rcvd at Ctr Date 03/18/2020 

HHE Sent 

HHE Signed 

HHE Precedent P-7907 

Outbreak Associated N 

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 37-BYT21

Precedent Recall P-7907 

Precedent Policy 

Precedent Policy Comment The level of risk to health posed by the violative product is similar to the level or risk previously 

evaluated in the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market Green Chile Chicken Tamale served as a Family Meal, Chef's Case, 

Packaged, Frozen and on he hot bar PLU 72429 packaged in plastic containers and in familystyle meal kits 

Trade Name (Int) Whole Foods Market 

Generic Name (Int)

Product Usage Food for human consumption 

Product Quantity Distributed (Int)

Recall Number (Int) F-0846-2020 

Product Public Reason for Recall (Int) Contains undeclared milk 

Field Recommended Classification Class I 

Center Determination/Classification (Int) Class I 

Center Recommended Depth Consumers/User 

Product Effectiveness Check Level A Percent 100 

(b) (4)
Product Audit Check Level E Percent 0 

Code Information (Int) Product Code (begins with) 224401, 237593, 272405,237597, 272429, 277626, 272435; Best 

By Through 3/7/2020-3/31/2020; Packed date from February 28th 2020 to March 1st, 2020 

Expected Life 

Shelf Life 3/31/20 

CFSAN Reason Labeling/undeclared allergen 

Recalling Firm Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title CEO/President 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address Craig.Penigar@wholefoods.com

Comment 

Manufacturer Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 
Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Responsible Firm Information

FEI 3007331558 

Firm Type Manufacturer 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Recall Contact

Official's Name Craig Penigar 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address Craig.Penigar@wholefoods.com

Comment 

Public Contact

Official's Name 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 
Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address 

Comment Contact: Rachel Malish Rachel.malish@wholefoods.com

Summary Help 

WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 

Printed by: Tyra S. Wisecup 

Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration 
Recalls 13.5 

Home 

Event ID: 85465 Status: Terminated Updated: 06/02/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 85465 RFR EON ID 

Recall Number(s) F-0925-2020 RFR EON URLs 

District Human And Animal Food West III Coordinator Casey Hamblin 

Firm Awareness Date 04/10/2020 District Awareness Date 04/10/2020 

Center (Int) Center for Food Safety and 

Applied Nutrition 

Coordinator 

Melanie Butler 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 1222010 Name (Int) Kettle Cuisine, LLC 

Responsible Firm FEI 3007331558 Name Whole Foods Market 

Public Reason for Recall May contain undeclared milk 

Edit Mode Viewable Recall Status (Int) Terminated 

Voluntary/Mandated (Int) Firm Initiated Date (Int) 04/10/2020 

Firm Recommended Recall Depth Consumers/User Date Distribution Chain Notified 04/10/2020 

Recall Initiation Date (Int) 04/10/2020 Firm Initial Notification Combination

Determination Date 04/29/2020 Center Coordinator Assigned Date 04/23/2020 

Classification Date 04/29/2020 FDA Sample Number None 

Complete Reason for Recall Milk was not declared as an allergen on the scale label. A store employee noticed that the ingredient list on 

the case label didn't match with the stores scale label. 
Root Cause Other 

Root Cause Narrative The old formulation was still in the system as teams worked through inventory, and was never removed once 

inventory was gone. The wrong item was used in the new recipes that had incorrect ingredients/allergens and 

was missing MILK. 

Center Comments Class I. CFSAN concurs with audit check strategy. 

Type Of Injury None reported. 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees 

Number of Foreign Consignees 0 

Distributed From 03/17/2020To 04/10/2020 

Distribution Pattern (Int) Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Georgia, Hawaii, Idaho, Kansas, 

Kentucky, Louisiana, Massachusetts, Maryland, Maine, Missouri, Mississippi, North Carolina, New 

Hampshire, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South 

Carolina, Tennessee, Texas, Utah, Virginia and Washington. 

Manufactured From 03/17/2020To 04/10/2020 

Public Summary of Recall Strategy 

(Int)

On 4/10/2020, all affected stores were notified of the recall via online communication and response software. 

Additionally, the firm issued a press release on 4/10/2020. 

Recall Strategy On 4/10/2020, the system notified all affected stores of the recall via online communication and 

response software. Additionally, the firm issued a press release on 4/10/2020. 

Effectiveness Check Level APercent 100 

Audit Check Level EPercent 0 

Audit/Effectiveness Check 

Modification 

Due to the firm's extensive history of effective recalls, DRC recommends no RACs to be conducted. The firm 

utilizes an internal in store FoodIQ system that assists in effectuating the recalls. 

RAC Assignment Date Issued RAC Assignment Date Completed 

District RAC Assignment Needed? 

No 

District Justification for No Audit 

Check 

Other (explain in comments) 

District Recommendation for No 

Audit Check Comments 

Due to the firm's extensive history 

of effective recalls, DRC 

recommends no RACs to be 

conducted. The firm utilizes an 

internal in store FoodIQ system that 

assists in effectuating the recalls. 

Center Agrees with District RAC 

Assignment Recommendation 

Yes 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

Center Recommendation 

Justification Comments 

Center Entering Recall 

What Consumers Should Do (Int)

(b) (4) (b) (4) (b) (4) (b) (4)
Expanded Comments for 

What Consumers Should Do (Int)

Firm Press Issued (Int) 04/10/2020 URL (Int) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alertissued-undeclared-milk-minestrone-soup-sold-whole-foods-market-stores-32-states-and 

State Press Issued (Int) URL (Int) 

FDA Press Issued (Int) URL (Int) 

Additional Medical Product 

Information (Int)

URL (Int) 

Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

 No 

VA/DOD/Foreign consignees 

Consignees Approx. Number Consignees Approx. Number

Distributor 0 Repacker/Relabeler 0 

Retailer Direct Accounts 0

Institution 0 Veterans Administration 0

Medical Facility 0 Department of Defense 0 

Internet Sales 0 Manufacturer 0

Physician 0 USDA 0

Consumer/Patient 0 Other 0 

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

Product Disposition The affected product within date was relabeled with the correct label and allergen declaration. 

Number of Consignees Responding 

to Notification 

Effectiveness Check Information 367/367 = 100% 

Recall Audit Check Count Audit Count Summary : Not Available 

Audit Check Information No recall audit checks were conducted for this recall. The firm has an extensive history of effective recalls. 

Section of Law Violated Section 402(a)(1) and 403 of the Food, Drug, and Cosmetic Act 

Preventive Action Taken by Firm The recalling firm will re-defining end of life cycle process for items with reformulations 

District Follow-Up The labeling issue occurred at the retail store level, therefore there is not planned inspectional follow-up. 

District Review A review of the recall file was conducted during evaluation of this recall. The recall appears to be complete 

and effective. 

(b) (4) (b) (4) (b) (4) (b) (4)
Legal Action None planned. 

Class I Termination 

Recommendation 

DRC recommends recall termination. 

Recommended/Prepared By Casey Hamblin 

District Management Approval Jessica Havranek, DCB Date 05/22/2020 

Center Concurrence Angela Alexander 

Recall Completed Date 04/10/2020 

Termination Letter Date 

CFSAN Center Information

Docs Rcvd at Ctr Date 04/22/2020 

HHE Sent 

HHE Signed 

HHE Precedent P-7907 

Outbreak Associated N 

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 38-AGT18

Precedent Recall P-7907 

Precedent Policy 

Precedent Policy Comment The level of risk to health posed by the violative product is similar to the level of risk previously 

evaluated in the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market Minestrone Soup PLU code printed on the product scale labels beginning 

with 248529 for soup sold in clear plastic deli-style containers of various weight and 246691 for 

soup sold in clear plastic bags weighing 7 lbs. 12 oz. 

Trade Name (Int) Whole Foods Market 

Generic Name (Int)

Product Usage Food for human consumption 

Product Quantity Distributed (Int)

Recall Number (Int) F-0925-2020 

Product Public Reason for Recall (Int) May contain undeclared milk 

Field Recommended Classification Class I 

Center Determination/Classification (Int) Class I 

Center Recommended Depth Consumers/User 

Product Effectiveness Check Level A Percent 100 

Product Audit Check Level E Percent 0 

Code Information (Int) sell-by dates of 4/17/2020 and prior 

(b) (4)
Expected Life 

Shelf Life 7 days 

CFSAN Reason Labeling/undeclared allergen 

Recalling Firm Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title President/CEO 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 512-477-4455 Ext Country Code

Facsimile Ext Country Code

E-mail Address John.Mackey@wholefoods.com

Comment 

Manufacturer Information

FEI 1222010 

Firm Name (Int) Kettle Cuisine, LLC 

Address (Int) 330 Lynnway 

City (Int) Lynn 

State/Province (Int) Massachusetts 

Country (Int) United States 

Postal Code (Int) 01901-1706 

Telephone 617-409-7011 Ext Country Code
Comment 

Responsible Firm Information

FEI 3007331558 

Firm Type Repacker 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Recall Contact

Official's Name Craig Penigar 

Title Incident Management Team Lead 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 512-477-4455 Ext Country Code

Facsimile Ext Country Code

E-mail Address Craig.Penigar@wholefoods.com

Comment 

Public Contact

Official's Name Nathan Cimbala 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 844-936-8255 Ext Country Code

Facsimile Ext Country Code
E-mail Address Nathan.Cimbala@wholefoods.com

Comment Consumers with additional questions can call 1-844-936-8255 between the hours of 7:00 a.m. and 10:00 

p.m. CST, Monday through Friday, or 8:00 a.m. and 6:00 p.m. Saturday through Sunday. 

Summary Help 

WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 

Printed by: Tyra S. Wisecup 

Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration 
Recalls 13.5 

Home 

Event ID: 85947 Status: Terminated Updated: 07/23/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 85947 RFR EON ID 

Recall Number(s) F-1024-2020 RFR EON URLs 

District Human And Animal Food West III Coordinator Casey Hamblin 

Firm Awareness Date 06/24/2020 District Awareness Date 06/29/2020 

Center (Int) Center for Food Safety and

Applied Nutrition 

Coordinator 

Kelly Abraham 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 3002823211 Name (Int) Chuckanut Bay Foods LLC 

Responsible Firm FEI 3002823211 Name Chuckanut Bay Foods LLC 

Public Reason for Recall Undeclared walnuts 

Edit Mode Viewable Recall Status (Int) Terminated 

Voluntary/Mandated (Int) Firm Initiated Date (Int) 06/24/2020 

Firm Recommended Recall Depth Consumers/User Date Distribution Chain Notified 06/24/2020 

Recall Initiation Date (Int) 06/24/2020 Firm Initial Notification E-Mail 

Determination Date 07/14/2020 Center Coordinator Assigned Date 07/07/2020 

Classification Date 07/15/2020 FDA Sample Number None 
Complete Reason for Recall The recall was initiated when a store began individually packaging the product and discovered the 

manufacturer had mislabeled the product as Red Velvet Layered Cheesecake when it contained Carrot Cake 

Layered Cheesecake instead leading to an undeclared tree nut (walnut) allergen. The manufacturer initiated a 

recall as well under event 85941. 

Root Cause Other 

Root Cause Narrative According to the supplier, 

Center Comments Class II. CFSAN agrees with audit check strategy. 

Type Of Injury None reported 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees 

Number of Foreign Consignees 0 

Distributed From 6/24/2020To 6/26/2020 

Distribution Pattern (Int) California; Boise, Idaho; and Reno, Nevada 

Manufactured From 6/24/2020To 6/24/2020 

Public Summary of Recall Strategy 

(Int)

A press release was issued on 6/29/2020. Stores were notified of the issue via the internal electronic email 

system on 6/24/2020. The recalling firm began removing product from their shelves on 6/24/2020 and it was 

held for destruction. 

Recall Strategy A press release was issued on 6/29/2020. The recalling firm began removing product from their shelves on 

6/24/2020 and it was held for destruction. The WFM stores were notified of the issue via the internal 

electronic email system on 6/24/2020. 

Effectiveness Check Level APercent 100 

Audit Check Level EPercent 0 

Audit/Effectiveness Check 

Modification 

RAC Assignment Date Issued RAC Assignment Date Completed 

District RAC Assignment Needed? 

No 

District Justification for No Audit 

Check 

Firm has history of effective audit 

checks

District Recommendation for No 

Audit Check Comments 

Center Agrees with District RAC 

Assignment Recommendation 

Yes 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

Center Recommendation 

Justification Comments 

Center Entering Recall

What Consumers Should Do (Int)

Expanded Comments for 

What Consumers Should Do (Int)

(b) (4)

(b) (4) (b) (4) (b) (4)
Firm Press Issued (Int) 06/29/2020 URL (Int) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alertundeclared-tree-nut-red-velvet-cheesecake-slices-issued-whole-foods-market-stores 

State Press Issued (Int) URL (Int) 

FDA Press Issued (Int) URL (Int) 

Additional Medical Product 

Information (Int)

URL (Int) 

Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

No VA/DOD/Foreign consignees 

Consignees Approx. Number Consignees Approx. Number

Distributor 0 Repacker/Relabeler 0

Retailer Direct Accounts 0 

Institution 0 Veterans Administration 0

Medical Facility 0 Department of Defense 0

Internet Sales 0 Manufacturer 0 

Physician 0 USDA 0

Consumer/Patient 0 Other 0

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

cases and of the Red Velvet cake 

Product Disposition The product was destroyed at the store level 

Number of Consignees Responding 

to Notification 

 stores 

Effectiveness Check Information 47/47 = 100% 

Recall Audit Check Count Audit Count Summary : Not Available 

Audit Check Information No RACs were performed. The firm has an extensive history of effective recalls. However, HAFW6 forwarded 

3 RACs conducted at Whole Foods Market stores that were conducted under the recall RES 85941. The 

RACs were all endorsed as effective. 

Section of Law Violated Section 402 of the Food, Drug and Cosmetic Act 

Preventive Action Taken by Firm The supplier noted 

District Follow-Up HAFW6 will perform any follow-up actions at the manufacturing location. 

District Review A review of the recall file was conducted during evaluation of this recall. The recall appears to be complete 

and effective. 

(b) (4)

(b) (4)

(b) (4) (b) (4)

(b) (4)
Legal Action None planned 

Class I Termination 

Recommendation 

N/A 

Recommended/Prepared By Casey Hamblin 

District Management Approval Jessica Havranek, DCB Date 07/23/2020 

Center Concurrence

Recall Completed Date 06/29/2020 

Termination Letter Date 

CFSAN Center Information

Docs Rcvd at Ctr Date 07/07/2020 

HHE Sent 

HHE Signed 

HHE Precedent P-8063 

Outbreak Associated N 

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 03-Y99 

Precedent Recall P-8063 

Precedent Policy 

Precedent Policy Comment The level of risk to health posed by the violative product is similar to the level of risk previously

evaluated in the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market Red Velvet Layered Cheesecake Slice PLU: 78620 packaged in plastic 

clam shell with scale label applied 

Trade Name (Int) Whole Foods Market 

Generic Name (Int)

Product Usage Food for human consumption 

Product Quantity Distributed (Int)

Recall Number (Int) F-1024-2020 

Product Public Reason for Recall (Int) Undeclared walnuts 

Field Recommended Classification Class II 

Center Determination/Classification (Int) Class II 

Center Recommended Depth Consumers/User 

Product Effectiveness Check Level A Percent 100 

Product Audit Check Level E Percent 0 

Code Information (Int) sell-by dates through July 1, 2020 

(b) (4)
Expected Life 

Shelf Life 7/1/2020 

CFSAN Reason Labeling/undeclared allergen 

Recalling Firm Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title President/CEO 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 512-477-5566 Ext Country Code

Facsimile Ext Country Code

E-mail Address John.Mackey@wholefoods.com

Comment 

Manufacturer Information

FEI 3002823211 

Firm Name (Int) Chuckanut Bay Foods LLC 

Address (Int) 1649 Boblett St 

City (Int) Blaine 

State/Province (Int) Washington 

Country (Int) United States 

Postal Code (Int) 98230 

Telephone 360-380-1908 Ext Country Code
Comment 

Responsible Firm Information

FEI 3002823211 

Firm Type Manufacturer 

Firm Name (Int) Chuckanut Bay Foods LLC 

Address (Int) 1649 Boblett St 

City (Int) Blaine 

State/Province (Int) Washington 

Country (Int) United States 

Postal Code (Int) 98230 

Telephone 360-380-1908 Ext Country Code

Comment 

Recall Contact

Official's Name Craig Penigar 

Title Incident Manager Team Lead 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 512-477-5566 Ext Country Code

Facsimile Ext Country Code

E-mail Address Craig.Penigar@wholefoods.com

Comment 

Public Contact

Official's Name Rachel Malish 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code
E-mail Address Rachel.malish@wholefoods.com

Comment Consumers with additional questions can call 1-844-936-8255 between the hours of 7:00 a.m. and 10:00 

p.m. CST, Monday through Friday, or 8:00 a.m. and 6:00 p.m. Saturday through Sunday. 

Summary Help 

WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 

Printed by: Tyra S. Wisecup 

Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration 
Recalls 13.5 

Home 

Event ID: 86117 Status: Ongoing Updated: 08/04/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 86117 RFR EON ID 

Recall Number(s) F-1048-2020 RFR EON URLs 

District Human And Animal Food West III Coordinator Casey Hamblin 

Firm Awareness Date 07/23/2020 District Awareness Date 07/24/2020 

Center (Int) Center for Food Safety and 

Applied Nutrition 

Coordinator 

Dehlia Young 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 3007331558 Name (Int) Whole Foods Market 

Responsible Firm FEI 3007331558 Name Whole Foods Market 

Public Reason for Recall Potential to contain undeclared tree nuts (almond) 

Edit Mode Viewable Recall Status (Int) Ongoing 

Voluntary/Mandated (Int) Firm Initiated Date (Int) 07/23/2020 

Firm Recommended Recall Depth Consumers/User Date Distribution Chain Notified 07/23/2020 

Recall Initiation Date (Int) 07/23/2020 Firm Initial Notification Other 

Determination Date 08/04/2020 Center Coordinator Assigned Date 07/30/2020 

Classification Date 08/04/2020 FDA Sample Number None 
Complete Reason for Recall Undeclared tree nut - Almond. The recall was initiated during a routine internal audit when it was discovered 

that almond flour was missing from the product label. Team member discovered the ingredients on the scale 

label didn't match the ingredients found on the master case. 

Root Cause Other 

Root Cause Narrative Recipe was setup using the wrong case ordering identifier. 

Center Comments Class I. CFSAN concurs with audit check strategy. 

Type Of Injury No reactions reported 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees 

Number of Foreign Consignees 0 

Distributed From 7/12/2020To 7/23/2020 

Distribution Pattern (Int) Connecticut, Maine, Massachusetts, New Hampshire and Rhode Island 

Manufactured From 7/12/2020To 7/23/2020 

Public Summary of Recall Strategy 

(Int)

On 7/23/2020, retail stores were notified of the recall via an internal online communication. The recalling firm 

followed up with a press release on 7/24/2020. 

Recall Strategy On 7/23/2020, retail stores were notified of the recall via an internal online communication. The recalling firm 

followed up with a press release on 7/24/2020. 

Effectiveness Check Level APercent 100 

Audit Check Level EPercent 0 

Audit/Effectiveness Check 

Modification 

The recalling firm has an extensive history of effective recalls. 

RAC Assignment Date Issued RAC Assignment Date Completed 

District RAC Assignment Needed? 

No 

District Justification for No Audit 

Check 

Firm has history of effective audit 

checks

District Recommendation for No 

Audit Check Comments 

Center Agrees with District RAC 

Assignment Recommendation 

Yes 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

Center Recommendation 

Justification Comments 

Center Entering Recall 

What Consumers Should Do (Int)

Expanded Comments for 

What Consumers Should Do (Int)

Firm Press Issued (Int) 07/24/2020 URL (Int) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alertundeclared-tree-nut-almond-chantilly-key-lime-tartlets-issued-whole-foods-market

State Press Issued (Int) URL (Int) 

FDA Press Issued (Int) URL (Int) 

(b) (4) (b) (4)

(b) (4)
Additional Medical Product 

Information (Int)

URL (Int) 

Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

No VA/DOD/Foreign consignees. All affected consignees are 

Consignees Approx. Number Consignees Approx. Number

Distributor 0 Repacker/Relabeler 0

Retailer Direct Accounts 0 

Institution 0 Veterans Administration 0

Medical Facility 0 Department of Defense 0

Internet Sales 0 Manufacturer 0 

Physician 0 USDA 0

Consumer/Patient 0 Other 0

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

Product Disposition 

Number of Consignees Responding 

to Notification 

Effectiveness Check Information 

Recall Audit Check Count Audit Count Summary : Not Available 

Audit Check Information No RACs will be performed by FDA. The recalling firm has an effective internal recall communication system. 

Section of Law Violated Section 402 of the Food, Drug and Cosmetic Act 

Preventive Action Taken by Firm When PLUs come back for products that are being updated, the recalling firm will look up the PLU in 

ICON and make sure 

District Follow-Up 

District Review 

Legal Action None planned. 

Class I Termination 

Recommendation 

Recommended/Prepared By 

District Management Approval Date 

Center Concurrence

(b) (4)

(b) (5) (b) (5) (b) (4)
Recall Completed Date 

Termination Letter Date 

CFSAN Center Information

Docs Rcvd at Ctr Date 07/29/2020 

HHE Sent 

HHE Signed 

HHE Precedent P-7983 

Outbreak Associated N 

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 03-Y99 

Precedent Recall P-7983 

Precedent Policy 

Precedent Policy Comment The level of risk to health posed by the violative product is similar to the level or risk previously 

evaluated in the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Chantilly Key Lime Tartlets Net Wt 1 oz. individually packaged in plastic clamshell containers 

with Whole Foods Market scale labels, a PLU code of 268564 

Trade Name (Int) Whole Foods Market 

Generic Name (Int)

Product Usage Food for human consumption 

Product Quantity Distributed (Int)

Recall Number (Int) F-1048-2020 

Product Public Reason for Recall (Int) Potential to contain undeclared tree nuts (almond) 

Field Recommended Classification Class I 

Center Determination/Classification (Int) Class I 

Center Recommended Depth Consumers/User 

Product Effectiveness Check Level A Percent 100 

Product Audit Check Level E Percent 0 

Code Information (Int) PLU code of 2685640000, and product sell-by date through July 26, 2020 

Expected Life 

Shelf Life 7/26/2020 

CFSAN Reason Labeling/undeclared allergen 

Recalling Firm Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

(b) (4)
Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title President 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address john.mackey@wholefoods.com

Comment 

Manufacturer Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Responsible Firm Information

FEI 3007331558 

Firm Type Manufacturer 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 
City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Recall Contact

Official's Name Craig Penigar 

Title Global Quality Assurance and Incident Management 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address Craig.Penigar@wholefoods.com

Comment 

Public Contact

Official's Name Rachel Malish 

Title Media Contact 

Firm Name (Int) Whole Foods Market

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address Rachel.malish@wholefoods.com

Comment 

Summary Help 

WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 
Printed by: Tyra S. Wisecup 

Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration 
Recalls 13.5 

Home 

Event ID: 86118 Status: Ongoing Updated: 08/07/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 86118 RFR EON ID 

Recall Number(s) F-1145-2020 RFR EON URLs 

District Human And Animal Food West III Coordinator Casey Hamblin 

Firm Awareness Date 07/24/2020 District Awareness Date 07/24/2020 

Center (Int) Center for Food Safety and 

Applied Nutrition 

Coordinator 

Dehlia Young 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 3003814927 Name (Int) Boston Gourmet Chefs, Inc. 

Responsible Firm FEI 3007331558 Name Whole Foods Market 

Public Reason for Recall Potential to contain undeclared eggs 

Edit Mode Viewable Recall Status (Int) Ongoing 

Voluntary/Mandated (Int) Firm Initiated Date (Int) 07/24/2020 

Firm Recommended Recall Depth Consumers/User Date Distribution Chain Notified 07/24/2020 

Recall Initiation Date (Int) 07/24/2020 Firm Initial Notification Combination

Determination Date 08/07/2020 Center Coordinator Assigned Date 08/04/2020 

Classification Date 08/07/2020 FDA Sample Number None 
Complete Reason for Recall The recall was initiated when a store team member noticed the discrepancy on the label leaving off the egg 

allergen. Team member discovered the ingredients on the scale label didn't match the ingredients found on 

the master case. 

Root Cause Other 

Root Cause Narrative Regional team was using a WFM provided identifier instead of the UPC provided by the supplier. 

Center Comments Class I. CFSAN concurs with audit check strategy. 

Type Of Injury None reported 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees 

Number of Foreign Consignees 0 

Distributed From 7/24/2020To 7/24/2020 

Distribution Pattern (Int) Colorado, Kansas, Missouri, Nebraska, New Mexico, Texas and Utah. 

Manufactured From 7/24/2020To 7/24/2020 

Public Summary of Recall Strategy 

(Int)

On 7/24/2020, the recalling firm notified all affected WFM retail stores via an online communication via the 

internal recall platform. Additionally, a press release was issued on 7/24/2020. 

Recall Strategy On 7/24/2020, the recalling firm notified all affected WFM retail stores via an online communication via the 

internal recall platform. Additionally, a press release was issued on 7/24/2020. The affected product was 

relabeled in stores. 

Effectiveness Check Level APercent 100 

Audit Check Level EPercent 0 

Audit/Effectiveness Check 

Modification 

The firm has an extensive history of effective recalls. 

RAC Assignment Date Issued RAC Assignment Date Completed 

District RAC Assignment Needed? 

No 

District Justification for No Audit 

Check 

Firm has history of effective audit 

checks

District Recommendation for No 

Audit Check Comments 

Center Agrees with District RAC 

Assignment Recommendation 

Yes 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

Center Recommendation 

Justification Comments 

Center Entering Recall 

What Consumers Should Do (Int)

Expanded Comments for 

What Consumers Should Do (Int)

Firm Press Issued (Int) 07/24/2020 URL (Int) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alertundeclared-egg-kouign-amann-pastries-issued-select-whole-foods-market-stores-seven

State Press Issued (Int) URL (Int) 

(b) (4) (b) (4) (b) (4)
FDA Press Issued (Int) URL (Int) 

Additional Medical Product 

Information (Int)

URL (Int) 

Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

No VA/DOD/Foreign consignees 

Consignees Approx. Number Consignees Approx. Number

Distributor 0 Repacker/Relabeler 0 

Retailer Direct Accounts 0

Institution 0 Veterans Administration 0

Medical Facility 0 Department of Defense 0 

Internet Sales 0 Manufacturer 0

Physician 0 USDA 0

Consumer/Patient 0 Other 0 

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

Product Disposition The recalled product was relabeled in the retail stores. 

Number of Consignees Responding 

to Notification 

Effectiveness Check Information 

Recall Audit Check Count Audit Count Summary : Not Available 

Audit Check Information 

Section of Law Violated Section 402 (a)(1) of the Food, Drug and Cosmetic Act 

Preventive Action Taken by Firm 1) Worked with the Supplier to update spec sheets to clearly state the allergens present. 2) All data was 

cleaned up in WFM system. 3) to 

prevent this in the future. 

District Follow-Up 

District Review 

Legal Action None planned 

Class I Termination 

Recommendation 

Recommended/Prepared By 

(b) (4) (b) (5)
District Management Approval Date 

Center Concurrence 

Recall Completed Date 

Termination Letter Date 

CFSAN Center Information

Docs Rcvd at Ctr Date 08/03/2020 

HHE Sent 

HHE Signed 

HHE Precedent P-7968 

Outbreak Associated N 

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 03-Y99 

Precedent Recall P-7968 

Precedent Policy 

Precedent Policy Comment The level of risk to health posed by the violative product is similar to the level or risk previously 

evaluated in the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Kouign-Amann Pastry available in plastic clamshell 4-packs with Whole Foods Market scale 

labels, a PLU code 26739400000 

Trade Name (Int) Whole Foods Market 

Generic Name (Int)

Product Usage Food for human consumption 

Product Quantity Distributed (Int)

Recall Number (Int) F-1145-2020 

Product Public Reason for Recall (Int) Potential to contain undeclared eggs 

Field Recommended Classification Class I 

Center Determination/Classification (Int) Class I 

Center Recommended Depth Consumers/User 

Product Effectiveness Check Level A Percent 100 

Product Audit Check Level E Percent 0 

Code Information (Int) PLU code 26739400000 and a sell through date of July 27, 2020 

Expected Life 

Shelf Life 7/27/2020 

CFSAN Reason Labeling/undeclared allergen 

Recalling Firm Information

(b) (4)
FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title President 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address john.mackey@wholefoods.com

Comment 

Manufacturer Information

FEI 3003814927 

Firm Name (Int) Boston Gourmet Chefs, Inc. 

Address (Int) 2 Watson Pl 

City (Int) Framingham 

State/Province (Int) Massachusetts 

Country (Int) United States 

Postal Code (Int) 01701-4109 

Telephone 508-877-0000 Ext Country Code

Comment 

Responsible Firm Information

FEI 3007331558 

Firm Type Repacker 
Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Recall Contact

Official's Name Craig Penigar 

Title Global Quality Assurance and Incident Management 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address Craig.Penigar@wholefoods.com

Comment 

Public Contact

Official's Name 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address 

Comment Consumers with additional questions can call 1-844-936-8255 between the hours of 7:00 a.m. and 10:00 

p.m. CST, Monday through Friday, or 8:00 a.m. and 6:00 p.m. Saturday through Sunday. 
Summary Help 

WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 

Printed by: Tyra S. Wisecup 

Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration 
Recalls 13.5 

Home 

Event ID: 86252 Status: Ongoing Updated: 09/01/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 86252 RFR EON ID 

Recall Number(s) F-1354-2020 F-1355-2020 F RFR EON URLs 

-1356-2020 F-1357-2020 F1358-2020 F-1359-2020 F1360-2020 F-1361-2020 F1362-2020 

District Human And Animal Food West III Coordinator Casey Hamblin 

Firm Awareness Date 08/09/2020 District Awareness Date 08/12/2020 

Center (Int) Center for Food Safety and 

Applied Nutrition 

Coordinator 

Dehlia Young 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 3007331558 Name (Int) Whole Foods Market 

Responsible Firm FEI 3007331558 Name Whole Foods Market 

Public Reason for Recall Undeclared lysozyme (from egg whites) 

Edit Mode Viewable Recall Status (Int) Ongoing

Voluntary/Mandated (Int) Firm Initiated Date (Int) 08/10/2020 

Firm Recommended Recall Depth Retail Date Distribution Chain Notified 08/10/2020 

Recall Initiation Date (Int) 08/10/2020 Firm Initial Notification E-Mail 

Determination Date 09/01/2020 Center Coordinator Assigned Date 08/27/2020
Classification Date 09/01/2020 FDA Sample Number None 

Complete Reason for Recall The issue was discovered when a customer was comparing the El Trigal 12-month-old Manchego cheese to 

the 6-month and 60-day aged Manchego cheeses and discovered that egg was missing from the 12-month 

label. This was reported to a store on 8/9/2020. Whole Foods Market Global Incident Management Team 

began investigating and pulling mislabeled product from affected stores. The investigation has determined 

that there are 12 cheese products including Manchego that contain lysozyme (from egg white) as an 

ingredient but egg is not listed on the ingredient statement. In the El Trigal Manchego Cheese, lysozyme is at 

very low levels, 0.002% of ingredients. 

Root Cause Other 

Root Cause Narrative Whole Foods Market regions individually control the ingredient statement data listed on the label. Certain 

regions had not updated their 

Center Comments Class I. CFSAN concurs with audit check strategy. 

Type Of Injury None reported to date 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees 

Number of Foreign Consignees 0 

Distributed From 07/11/2020To 08/11/2020 

Distribution Pattern (Int) Nationwide throughout the United States 

Manufactured From 07/11/2020To 08/10/2020 

Public Summary of Recall Strategy 

(Int)

The recall was communicated to stores via email through on 8/10/2020, which is the recall 

management tool. 

Recall Strategy The recall was communicated to stores via email through on 8/10/2020, which is the recall 

management tool. The Recall team enters the product information, withdrawal instructions, select affected 

stores, and communicate to stores through this portal. Amount destroyed/removed is also documented 

through this portal. 

Effectiveness Check Level APercent 100 

Audit Check Level EPercent 0 

Audit/Effectiveness Check 

Modification 

The firm has a history of effective recalls 

RAC Assignment Date Issued RAC Assignment Date Completed 

District RAC Assignment Needed? 

No 

District Justification for No Audit 

Check 

Firm has history of effective audit 

checks

District Recommendation for No 

Audit Check Comments 

Center Agrees with District RAC 

Assignment Recommendation 

Yes 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

Center Recommendation 

Justification Comments 

Center Entering Recall 

(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (5)
What Consumers Should Do (Int)

Expanded Comments for 

What Consumers Should Do (Int)

Firm Press Issued (Int) URL (Int) 

State Press Issued (Int) URL (Int) 

FDA Press Issued (Int) URL (Int) 

Additional Medical Product 

Information (Int)

URL (Int) 

Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

No VA/DOD/Foreign consignees. 

Consignees Approx. Number Consignees Approx. Number 

Distributor 0 Repacker/Relabeler 0

Retailer Direct Accounts 0

Institution 0 Veterans Administration 0 

Medical Facility 0 Department of Defense 0

Internet Sales 0 Manufacturer 0

Physician 0 USDA 0 

Consumer/Patient 0 Other 0

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

Product Disposition 

Number of Consignees Responding 

to Notification 

Effectiveness Check Information 

Recall Audit Check Count Audit Count Summary : Not Available 

Audit Check Information 

Section of Law Violated 

Preventive Action Taken by Firm 

District Follow-Up 

District Review 

Legal Action 

(b) (4)
Class I Termination 

Recommendation 

Recommended/Prepared By 

District Management Approval Date 

Center Concurrence 

Recall Completed Date 

Termination Letter Date 

CFSAN Center Information

Docs Rcvd at Ctr Date 08/26/2020 

HHE Sent 

HHE Signed 

HHE Precedent P-7968 

Outbreak Associated N 

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 12-Y99 

Precedent Recall P-7968 

Precedent Policy 

Precedent Policy Comment The level of risk to health posed by the violative product is similar to the level or risk previously 

evaluated in the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market El Trigal 12 Month Old Manchego PLU 29329500000; Whole Foods 

Market El Trigal 6 Month Old Manchego PLU 29329900000; Whole Foods Market Mitica 

Cordobes PLU 29335700000; Individual sliced cheese wrapped in plastic wrap with scale label 

on top. 

Trade Name (Int) Whole Foods Market 

Generic Name (Int)

Product Usage Food for human consumption 

Product Quantity Distributed (Int)

Recall Number (Int) F-1354-2020 

Product Public Reason for Recall (Int) Undeclared lysozyme (from egg whites) 

Field Recommended Classification Class II 

Center Determination/Classification (Int) Class I 

Center Recommended Depth Retail 

Product Effectiveness Check Level A Percent 100 

Product Audit Check Level E Percent 0 

Code Information (Int) Sell by dates: until September 11, 2020 

(b) (4)
Expected Life 

Shelf Life 30 days 

CFSAN Reason Labeling/undeclared allergen 

Product : 2 Industry-Product Code

12-Y99 Precedent Recall 

P-7968 Precedent Policy 

Precedent Policy Comment 

The level of risk to health posed by the violative product is similar to the level or risk previously evaluated in 

the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market Artequeso Manchego 6 month aged raw Raw Milk - Aged 60 days or more PLU 

20057900000 Individual sliced cheese wrapped in plastic wrap with scale label on top. 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

F-1355-2020 

Product Public Reason for Recall 

(Int)

Undeclared lysozyme (from egg whites) Field Recommended Classification 

Class II 

Center Determination/Classification

(Int)

Class I Center Recommended Depth 

Retail Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Sell by dates: until September 11, 2020 Expected Life 

Shelf Life 

30 days CFSAN Reason 

Product : 3 Industry-Product Code

12-Y99 Precedent Recall 

P-7968 Precedent Policy 

Precedent Policy Comment 

The level of risk to health posed by the violative product is similar to the level or risk previously evaluated in 

the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market La Marquesa Herb Manchego Raw Milk - Aged 60 days or More PLU 29399800000 

Individual sliced cheese wrapped in plastic wrap with scale label on top. 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

(b) (4)
Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

F-1356-2020 

Product Public Reason for Recall 

(Int)

Undeclared lysozyme (from egg whites) Field Recommended Classification 

Class II 

Center Determination/Classification

(Int)

Class I Center Recommended Depth 

Retail Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Sell by dates: until September 11, 2020 Expected Life 

Shelf Life 

30 days CFSAN Reason 

Product : 4 Industry-Product Code

12-Y99 Precedent Recall 

P-7968 Precedent Policy 

Precedent Policy Comment 

The level of risk to health posed by the violative product is similar to the level or risk previously evaluated in 

the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market Mitica La Dama Sagrada Raw Milk - Aged 60 Days or More PLU 20656400000 

Individual sliced cheese wrapped in plastic wrap with scale label on top. 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

F-1357-2020 

Product Public Reason for Recall 

(Int)

Undeclared lysozyme (from egg whites) Field Recommended Classification 

Class II 

Center Determination/Classification

(Int)

Class I Center Recommended Depth 

Retail Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

(b) (4) (b) (4)
Sell by dates: until September 11, 2020 Expected Life 

Shelf Life 

30 days CFSAN Reason 

Product : 5 Industry-Product Code

12-Y99 Precedent Recall 

P-7968 Precedent Policy 

Precedent Policy Comment 

The level of risk to health posed by the violative product is similar to the level or risk previously evaluated in 

the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market Chimay Biere PLU 29351700000 Individual sliced cheese wrapped in plastic wrap with 

scale label on top. 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

F-1358-2020 

Product Public Reason for Recall 

(Int)

Undeclared lysozyme (from egg whites) Field Recommended Classification 

Class II 

Center Determination/Classification

(Int)

Class I Center Recommended Depth 

Retail Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Sell by dates: until September 11, 2020 Expected Life 

Shelf Life 

30 days CFSAN Reason 

Product : 6 Industry-Product Code

12-Y99 Precedent Recall 

P-7968 Precedent Policy 

Precedent Policy Comment 

The level of risk to health posed by the violative product is similar to the level or risk previously evaluated in 

the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market IL FORTETO Genovese Pesto PLU 20017100000 Individual sliced cheese wrapped in 

plastic wrap with scale label on top. 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

(b) (4)
Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

F-1359-2020 

Product Public Reason for Recall 

(Int)

Undeclared lysozyme (from egg whites) Field Recommended Classification 

Class II 

Center Determination/Classification

(Int)

Class I Center Recommended Depth 

Retail Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Sell by dates: until September 11, 2020 Expected Life 

Shelf Life 

30 days CFSAN Reason 

Product : 7 Industry-Product Code

12-Y99 Precedent Recall 

P-7968 Precedent Policy 

Precedent Policy Comment 

The level of risk to health posed by the violative product is similar to the level or risk previously evaluated in 

the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market Chimay Grand Cru PLU 29388800000 and Whole Foods Market Lactalis MIMOLETTE 

Aged 12 MONTHS PLU 25704400000 Individual sliced cheese wrapped in plastic wrap with scale label on 

top. 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

F-1360-2020 

Product Public Reason for Recall 

(Int)

Undeclared lysozyme (from egg whites) Field Recommended Classification 

Class II 

Center Determination/Classification

(Int)

Class I Center Recommended Depth 

Retail Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

(b) (4) (b) (4)
Sell by dates: until September 11, 2020 Expected Life 

Shelf Life 

30 days CFSAN Reason 

Product : 8 Industry-Product Code

12-Y99 Precedent Recall 

P-7968 Precedent Policy 

Precedent Policy Comment 

The level of risk to health posed by the violative product is similar to the level or risk previously evaluated in 

the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market Mitica Mahon PLU 29341800000 Individual sliced cheese wrapped in plastic wrap with 

scale label on top. 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

F-1361-2020 

Product Public Reason for Recall 

(Int)

Undeclared lysozyme (from egg whites) Field Recommended Classification 

Class II 

Center Determination/Classification

(Int)

Class I Center Recommended Depth 

Retail Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Sell by dates: until September 11, 2020 Expected Life 

Shelf Life 

30 days CFSAN Reason 

Product : 9 Industry-Product Code

12-Y99 Precedent Recall 

P-7968 Precedent Policy 

Precedent Policy Comment 

The level of risk to health posed by the violative product is similar to the level or risk previously evaluated in 

the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market AGRIFORM PIAVE VECCHIO PLU 29336200000 Individual sliced cheese wrapped in 

plastic wrap with scale label on top. 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

(b) (4)
Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

F-1362-2020 

Product Public Reason for Recall 

(Int)

Undeclared lysozyme (from egg whites) Field Recommended Classification 

Class II 

Center Determination/Classification

(Int)

Class I Center Recommended Depth 

Retail Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Sell by dates: until September 11, 2020 Expected Life 

Shelf Life 

30 days CFSAN Reason 

Recalling Firm Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title CEO/President 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 512-542-2200 Ext Country Code

(b) (4)
Facsimile Ext Country Code

E-mail Address John.Mackey@wholefoods.com

Comment 

Manufacturer Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Responsible Firm Information

FEI 3007331558 

Firm Type Manufacturer 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Recall Contact

Official's Name Ashley Zuaiter 

Title QA Incident Analyst 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 512-542-2200 Ext Country Code

Facsimile Ext Country Code

E-mail Address Ashley.Zuaiter@wholefoods.com
Comment 

Public Contact

Official's Name 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address 

Comment 

Summary Help 

WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 

Printed by: Tyra S. Wisecup 

Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration 
Recalls 13.5 

Home 

Event ID: 86275 Status: Ongoing Updated: 08/21/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 86275 RFR EON ID 

Recall Number(s) F-1257-2020 RFR EON URLs 

District Human And Animal Food West III Coordinator Casey Hamblin 

Firm Awareness Date 08/05/2020 District Awareness Date 08/06/2020 

Center (Int) Center for Food Safety and 

Applied Nutrition 

Coordinator 

Melanie Butler 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 3007331558 Name (Int) Whole Foods Market 

Responsible Firm FEI 3007331558 Name Whole Foods Market 

Public Reason for Recall Undeclared soy allergen 

Edit Mode Viewable Recall Status (Int) Ongoing 

Voluntary/Mandated (Int) Firm Initiated Date (Int) 08/06/2020 

Firm Recommended Recall Depth Retail Date Distribution Chain Notified 08/06/2020

Recall Initiation Date (Int) 08/06/2020 Firm Initial Notification E-Mail 

Determination Date 08/21/2020 Center Coordinator Assigned Date 08/20/2020 

Classification Date 08/21/2020 FDA Sample Number None 

Complete Reason for Recall Undeclared soy allergen from an ingredient. The source of the soy is Soy Shortening Flakes. A team 

member discovered the discrepancy while labeling the product. 
Root Cause Other 

Root Cause Narrative The ingredient deck and allergen declaration was not updated once the raw material (biscuit mix) was 

switched. 

Center Comments Class II. CFSAN concurs with audit check strategy. 

Type Of Injury None reported 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees 

Number of Foreign Consignees 0 

Distributed From 8/5/2020To 8/6/2020 

Distribution Pattern (Int) North Carolina, Alabama, South Carolina, Georgia, Tennessee, Mississippi 

Manufactured From 8/5/2020To 8/5/2020 

Public Summary of Recall Strategy 

(Int)

The recalling firm notified affected stores via the online recall communication system on 8/6/2020. 

Recall Strategy The recalling firm notified affected stores via the online recall communication system on 8/6/2020. Product 

was relabeled or destroyed given the short shelf life. 

Effectiveness Check Level APercent 100 

Audit Check Level EPercent 0 

Audit/Effectiveness Check 

Modification 

RAC Assignment Date Issued RAC Assignment Date Completed 

District RAC Assignment Needed? 

No 

District Justification for No Audit 

Check 

Firm has history of effective audit 

checks

District Recommendation for No 

Audit Check Comments 

Center Agrees with District RAC 

Assignment Recommendation 

Yes 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

Center Recommendation 

Justification Comments 

Center Entering Recall 

What Consumers Should Do (Int)

Expanded Comments for 

What Consumers Should Do (Int)

Firm Press Issued (Int) URL (Int) 

State Press Issued (Int) URL (Int) 

FDA Press Issued (Int) URL (Int) 

Additional Medical Product 

Information (Int)

URL (Int) 

(b) (4) (b) (4) (b) (4)
Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

No VA/DOD/Foreign consignees 

Consignees Approx. Number Consignees Approx. Number

Distributor 0 Repacker/Relabeler 0

Retailer Direct Accounts 0

Institution 0 Veterans Administration 0

Medical Facility 0 Department of Defense 0

Internet Sales 0 Manufacturer 0

Physician 0 USDA 0 

Consumer/Patient 0 Other 0

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

Product Disposition 

Number of Consignees Responding 

to Notification 

Effectiveness Check Information 

Recall Audit Check Count Audit Count Summary : Not Available 

Audit Check Information 

Section of Law Violated Section 402 and 403 of the Food, Drug and Cosmetic Act 

Preventive Action Taken by Firm Team is to thoroughly review any item change to determine if ingredient or allergen change will occur. Item 

must have a new PLU created when ingredient swap contains an allergen change. 

District Follow-Up 

District Review 

Legal Action None planned 

Class I Termination 

Recommendation 

Recommended/Prepared By 

District Management Approval Date 

Center Concurrence 

Recall Completed Date 

Termination Letter Date 

(b) (4)
CFSAN Center Information

Docs Rcvd at Ctr Date 08/19/2020 

HHE Sent 

HHE Signed 

HHE Precedent P-7799 

Outbreak Associated N 

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 03-AGT03

Precedent Recall P-7799 

Precedent Policy 

Precedent Policy Comment The level of risk to health posed by the violative product is similar to the level of risk previously 

evaluated in the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market Buttermilk Biscuits, 4pk NET WT 1lb 0 oz PLU: 30561 packaged in plastic 

clam shell 

Trade Name (Int) Whole Foods Market 

Generic Name (Int)

Product Usage Food for human consumption 

Product Quantity Distributed (Int)

Recall Number (Int) F-1257-2020 

Product Public Reason for Recall (Int) Undeclared soy allergen 

Field Recommended Classification Class II 

Center Determination/Classification (Int) Class II 

Center Recommended Depth Retail 

Product Effectiveness Check Level A Percent 100 

Product Audit Check Level E Percent 0 

Code Information (Int) Sell though 8/8/20 

Expected Life 

Shelf Life 3 days 

CFSAN Reason Labeling/undeclared allergen 

Recalling Firm Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

(b) (4)
State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title President 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 512-542-2200 Ext Country Code

Facsimile Ext Country Code

E-mail Address John.mackey@wholefoods.com

Comment 

Manufacturer Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Responsible Firm Information

FEI 3007331558 

Firm Type Manufacturer 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 
Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Recall Contact

Official's Name Craig Penigar 

Title Incident Management Team Lead 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 512-542-2200 Ext Country Code

Facsimile Ext Country Code

E-mail Address Craig.penigar@wholefoods.com

Comment 

Public Contact

Official's Name 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address 

Comment 

Summary Help 

WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 

Printed by: Tyra S. Wisecup 
Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration 
Recalls 13.5 

Home 

Event ID: 86277 Status: Ongoing Updated: 09/08/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 86277 RFR EON ID 

Recall Number(s) F-1430-2020 RFR EON URLs 

District Human And Animal Food West III Coordinator Casey Hamblin 

Firm Awareness Date 08/18/2020 District Awareness Date 08/19/2020 

Center (Int) Center for Food Safety and 

Applied Nutrition 

Coordinator 

Melanie Butler 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 3007331558 Name (Int) Whole Foods Market 

Responsible Firm FEI 3007331558 Name Whole Foods Market 

Public Reason for Recall undeclared soy (soy milk) allergen 

Edit Mode Viewable Recall Status (Int) Ongoing 

Voluntary/Mandated (Int) Firm Initiated Date (Int) 08/18/2020 

Firm Recommended Recall Depth Consumers/User Date Distribution Chain Notified 08/18/2020 

Recall Initiation Date (Int) 08/18/2020 Firm Initial Notification Other 

Determination Date 09/08/2020 Center Coordinator Assigned Date 09/03/2020 

Classification Date 09/08/2020 FDA Sample Number None 

Complete Reason for Recall The recalled is initiated due to an undeclared soy (soy milk) allergen. The recall was initiated when a Team 

Member conducting a labeling audit identified the missing ingredient. 
Root Cause Other 

Root Cause Narrative The recalling firm did not update the product scale labels to reflect Soy as an allergen when we switched to a 

new frosting. 

Center Comments Class I. CFSAN concurs with audit check strategy. 

Type Of Injury No allergic reactions have been reported to date 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees 

Number of Foreign Consignees 0 

Distributed From 8/19/2020To 8/19/2020 

Distribution Pattern (Int) Alabama, Georgia, Mississippi, North Carolina, South Tennessee and one store in Tallahassee, Florida 

Manufactured From 8/18/2020To 8/18/2020 

Public Summary of Recall Strategy 

(Int)

The recalling firm issued a press release on 8/20/2020. Additionally, affected stores were notified vie 

electronic recall system on 8/18/2020 

Recall Strategy The recalling firm issued a press release on 8/20/2020. Additionally, affected stores were notified vie 

electronic recall system on 8/18/2020 

Effectiveness Check Level APercent 100 

Audit Check Level EPercent 0 

Audit/Effectiveness Check 

Modification 

RAC Assignment Date Issued RAC Assignment Date Completed 

District RAC Assignment Needed? 

No 

District Justification for No Audit 

Check 

Firm has history of effective audit 

checks

District Recommendation for No 

Audit Check Comments 

Center Agrees with District RAC 

Assignment Recommendation 

Yes 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

Center Recommendation 

Justification Comments 

Center Entering Recall 

What Consumers Should Do (Int)

Expanded Comments for 

What Consumers Should Do (Int)

Firm Press Issued (Int) 08/20/2020 URL (Int) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alertundeclared-soy-soy-milk-vegan-vanilla-cake-issued-whole-foods-market-stores-seven

State Press Issued (Int) URL (Int) 

FDA Press Issued (Int) URL (Int) 

Additional Medical Product 

Information (Int)

URL (Int) 

(b) (4) (b) (4) (b) (4)
Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

No VA/DOD/Foreign consignees 

Consignees Approx. Number Consignees Approx. Number

Distributor 0 Repacker/Relabeler 0

Retailer Direct Accounts 0

Institution 0 Veterans Administration 0

Medical Facility 0 Department of Defense 0

Internet Sales 0 Manufacturer 0

Physician 0 USDA 0 

Consumer/Patient 0 Other 0

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

Product Disposition 

Number of Consignees Responding 

to Notification 

Effectiveness Check Information 

Recall Audit Check Count Audit Count Summary : Not Available 

Audit Check Information 

Section of Law Violated 

Preventive Action Taken by Firm Going forward, all ingredient changes will require spec sheets to be reviewed by multiple stakeholders to 

ensure the update process is followed. 

District Follow-Up 

District Review 

Legal Action None planned 

Class I Termination 

Recommendation 

Recommended/Prepared By 

District Management Approval Date 

Center Concurrence 

Recall Completed Date 

Termination Letter Date 

(b) (4)
CFSAN Center Information

Docs Rcvd at Ctr Date 09/02/2020 

HHE Sent 

HHE Signed 

HHE Precedent P-7841 

Outbreak Associated N 

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 03-RGT01

Precedent Recall P-7841 

Precedent Policy 

Precedent Policy Comment The level of risk to health posed by the violative product is similar to the level of risk previously 

evaluated in the identified precedent HHE. 

Product Description (Int)

(Label/Packaging)

Whole Foods Market Vegan Vanilla Cake 6 Inch NET WT 2lb 11oz (1219g) Packed for Whole 

Foods Market PLU 41070 packaged in plastic dome containers with Whole Foods Market scale 

labels 

Trade Name (Int) Whole Foods Market 

Generic Name (Int)

Product Usage Food for human consumption 

Product Quantity Distributed (Int)

Recall Number (Int) F-1430-2020 

Product Public Reason for Recall (Int) undeclared soy (soy milk) allergen 

Field Recommended Classification Class I 

Center Determination/Classification (Int) Class I 

Center Recommended Depth Consumers/User 

Product Effectiveness Check Level A Percent 100 

Product Audit Check Level E Percent 0 

Code Information (Int) PLU code of 41070 and product sell-by date through August 24, 2020. 

Expected Life 

Shelf Life 8/24/2020 

CFSAN Reason Labeling/undeclared allergen 

Recalling Firm Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

(b) (4)
State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title President 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address John.Mackey@wholefoods.com

Comment 

Manufacturer Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Responsible Firm Information

FEI 3007331558 

Firm Type Manufacturer 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 
Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Recall Contact

Official's Name Craig.Penigar 

Title Incident Management Team Lead 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address Craig.Penigar@wholefoods.com

Comment 

Public Contact

Official's Name 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code

E-mail Address 

Comment Media Contact: Rachel Malish Rachel.malish@wholefoods.com Consumers with additional questions can 

call 1-844-936-8255 between the hours of 7:00 a.m. and 10:00 p.m. CST, Monday through Friday, or 8:00 

a.m. and 6:00 p.m. Saturday through Sunday. 

Summary Help 

WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 
Printed by: Tyra S. Wisecup 

Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration 
Recalls 13.5 

Home 

Event ID: 86682 Status: Ongoing Updated: 11/06/2020 Role: 

Center Recall Coordinator

Recall Details

1. Event Information 

2. Summary and Termination Information 

3. Center Information 

4. Product Information 

5. Firm and Contact Information 

6. Recall Summary 

Event Information

Recall Event ID 86682 RFR EON ID 

Recall Number(s) RFR EON URLs 

District Human And Animal Food West III Coordinator Casey Hamblin 

Firm Awareness Date 10/24/2020 District Awareness Date 10/28/2020 

Center (Int) Center for Food Safety and 

Applied Nutrition 

Coordinator 

Recalling Firm FEI 3007331558 Name (Int) Whole Foods Market 

Manufacturer FEI 3007331558 Name (Int) Whole Foods Market 

Responsible Firm FEI 3007331558 Name Whole Foods Market 

Public Reason for Recall Potential to contain undeclared egg 

Edit Mode Viewable Recall Status (Int) Ongoing 

Voluntary/Mandated (Int) Firm Initiated Date (Int) 10/27/2020 

Firm Recommended Recall Depth Consumers/User Date Distribution Chain Notified 10/28/2020 

Recall Initiation Date (Int) 10/27/2020 Firm Initial Notification Combination

Determination Date Center Coordinator Assigned Date 

Classification Date FDA Sample Number None 
Complete Reason for Recall Whole Foods Market Stores within our Mid Atlantic region transitioned to a new Mac and cheese, which 

contains Egg on 10/23. During a review of the new Mac and Cheese, a team member noticed that the new 

products used old labels that do not list Egg in the ingredients or contains statements. 

Root Cause Other 

Root Cause Narrative It was not clear to the MA regional PFDS team that they needed to submit recipe adjustments for Globally 

managed product. Regional was not aware of a major allergen (EGG) change in the new Enterprise product. 

Regional PFDS contacted the Global Category team and CT team on Saturday 10/24 (after it was discovered 

no ingredient swaps were made) and sent a follow up email on 10/27. After the follow up email on 10/27, the 

Global procurement and CT nutrition team quickly helped take action. 

Center Comments

Type Of Injury None reported 

Quantity Manufactured 

Quantity Distributed (Int)

Number of Domestic Consignees 

Number of Foreign Consignees 0 

Distributed From 10/23/2020To 10/27/2020 

Distribution Pattern (Int) Maryland, New Jersey, Pennsylvania, Virginia and Washington, D.C. 

Manufactured From 10/23/2020To 10/27/2020 

Public Summary of Recall Strategy 

(Int)

The initial recall notification was sent to affected stores on 10/27/2020 via electronic recall system. A press 

release as issued on 10/28/2020. 

Recall Strategy The initial recall notification was sent to affected stores on 10/27/2020 via electronic recall system. A press 

release as issued on 10/28/2020. 

Effectiveness Check Level APercent 100 

Audit Check Level EPercent 0 

Audit/Effectiveness Check 

Modification 

RAC Assignment Date Issued RAC Assignment Date Completed 

District RAC Assignment Needed? 

No 

District Justification for No Audit 

Check 

Firm has history of effective audit 

checks

District Recommendation for No 

Audit Check Comments 

Center Agrees with District RAC 

Assignment Recommendation 

Center RAC Assignment Needed? Center Justification for No Audit 

Check 

Center Recommendation 

Justification Comments 

Center Entering Recall 

What Consumers Should Do (Int)

Expanded Comments for 

What Consumers Should Do (Int)

(b) (4) (b) (4) (b) (4)
Firm Press Issued (Int) 10/28/2020 URL (Int) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alertissued-undeclared-egg-prepared-macaroni-cheese-sold-whole-foods-market-stores-five

State Press Issued (Int) URL (Int) 

FDA Press Issued (Int) URL (Int) 

Additional Medical Product 

Information (Int)

URL (Int) 

Consignee Details

List of Domestic and/or Foreign Consignees, Distribution addresses or 

comments 

No VA/DOD/Foreign consignees 

Consignees Approx. Number Consignees Approx. Number

Distributor 0 Repacker/Relabeler 0

Retailer Direct Accounts 0 

Institution 0 Veterans Administration 0

Medical Facility 0 Department of Defense 0

Internet Sales 0 Manufacturer 0 

Physician 0 USDA 0

Consumer/Patient 0 Other 0

Summary/Termination Information

Quantity Recovered/Number of 

Units Corrected 

Product Disposition The individual stores applied the corrected labels with the allergens declared as soon as the issue was 

discovered. 

Number of Consignees Responding 

to Notification 

Effectiveness Check Information 

Recall Audit Check Count Audit Count Summary : Not Available 

Audit Check Information No RACs will be completed for this recall. The firm has a history of effective recalls due to their internal recall 

notification system. 

Section of Law Violated Section 402(a)(1) of the Foods, Drug and Cosmetic Act 

Preventive Action Taken by Firm Regional PFDS Team to improve communication with CT and Procurement team to ensure ingredient swaps 

are planned and properly in place before product hits region. 

District Follow-Up 

District Review 

Legal Action CFSAN planned action under CMS case 610862 

(b) (4)
Class I Termination 

Recommendation 

Recommended/Prepared By 

District Management Approval Date 

Center Concurrence 

Recall Completed Date 

Termination Letter Date 

CFSAN Center Information

Docs Rcvd at Ctr Date 

HHE Sent 

HHE Signed 

HHE Precedent 

Outbreak Associated

CFSAN CORE Incident EON ID 

Product Information

Product : 1

Industry-Product Code 04-Y99 

Precedent Recall 

Precedent Policy 

Precedent Policy Comment

Product Description (Int)

(Label/Packaging)

Macaroni & Cheese, chef s case; Macaroni & Cheese, packaged in clear plastic container; 

Macaroni & Cheese, online and catering product code begins with 286501, 263608, 114449, or 

109866 

Trade Name (Int) Whole Foods Market 

Generic Name (Int)

Product Usage Food for human consumption 

Product Quantity Distributed (Int)

Recall Number (Int)

Product Public Reason for Recall (Int) Potential to contain undeclared egg 

Field Recommended Classification Class I 

Center Determination/Classification (Int)

Center Recommended Depth 

Product Effectiveness Check Level A Percent 100 

Product Audit Check Level E Percent 0 

Code Information (Int) Best by dates through 10/28/2020 

Expected Life 

(b) (4)
Shelf Life 10/28/2020 

CFSAN Reason 

Product : 2 Industry-Product Code

04- Y99 Precedent Recall 

Precedent Policy 

Precedent Policy Comment 

Product Description (Int)

(Label/Packaging)

Rotisserie Chicken Meals with Mac & Cheese and Broccoli, packaged in clear plastic container with printed 

label product code begins with 261596 261580, 261590, 261601, 261608, or 261616 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

Product Public Reason for Recall 

(Int)

Potential to contain undeclared egg Field Recommended Classification 

Class I 

Center Determination/Classification

(Int)

Center Recommended Depth 

Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Best by dates through 10/28/2020 Expected Life 

Shelf Life 

10/28/2020 CFSAN Reason 

Product : 3 Industry-Product Code

04-Y99 Precedent Recall 

Precedent Policy 

Precedent Policy Comment 

Product Description (Int)

(Label/Packaging)

Fried Chicken Meal with Mac & Cheese, packaged in clear plastic container with printed label product code 

begins with 247257; Fried Chicken Meal with Mac & Cheese, packaged on hot bar product code begins with 

237444 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

(b) (4)
Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

Product Public Reason for Recall 

(Int)

Potential to contain undeclared egg Field Recommended Classification 

Class I 

Center Determination/Classification

(Int)

Center Recommended Depth 

Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Best by dates through 10/28/2020 Expected Life 

Shelf Life 

10/28/2020 CFSAN Reason 

Product : 4 Industry-Product Code

04-Y99 Precedent Recall 

Precedent Policy 

Precedent Policy Comment 

Product Description (Int)

(Label/Packaging)

Chicken Rustico Romano Chef Plate with Mac & Cheese and Broccoli, packaged in clear plastic container 

with printed label product code begins with 241442 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

Product Public Reason for Recall 

(Int)

Potential to contain undeclared egg Field Recommended Classification 

Class I 

Center Determination/Classification

(Int)

Center Recommended Depth 

Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

(b) (4) (b) (4)
Best by dates through 10/28/2020 Expected Life 

Shelf Life 

10/28/2020 CFSAN Reason 

Product : 5 Industry-Product Code

04-Y99 Precedent Recall 

Precedent Policy 

Precedent Policy Comment 

Product Description (Int)

(Label/Packaging)

Chicken Breast Chef Plate with Mac & Cheese and Broccoli, packaged in clear plastic container with printed 

label product code begins with 299430 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

Product Public Reason for Recall 

(Int)

Potential to contain undeclared egg Field Recommended Classification 

Class I 

Center Determination/Classification

(Int)

Center Recommended Depth 

Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Best by dates through 10/28/2020 Expected Life 

Shelf Life 

10/28/2020 CFSAN Reason 

Product : 6 Industry-Product Code

04-Y99 Precedent Recall 

Precedent Policy 

Precedent Policy Comment 

Product Description (Int)

(Label/Packaging)

BBQ Turkey Meatballs Chef Plate with Mac & Cheese and Green Beans, packaged in clear plastic container 

with printed label product code begins with 241464 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

(b) (4)
Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

Product Public Reason for Recall 

(Int)

Potential to contain undeclared egg Field Recommended Classification 

Class I 

Center Determination/Classification

(Int)

Center Recommended Depth 

Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

Best by dates through 10/28/2020 Expected Life 

Shelf Life 

10/28/2020 CFSAN Reason 

Product : 7 Industry-Product Code

04-Y99 Precedent Recall 

Precedent Policy 

Precedent Policy Comment 

Product Description (Int)

(Label/Packaging)

Roasted Turkey Chef Plate with Mac & Cheese and Broccoli, packaged in clear plastic container with printed 

label product code begins with 242019 

Trade Name (Int)

Whole Foods Market Generic Name (Int)

Product Usage 

Food for human consumption Product Quantity Distributed (Int)

Recall Number (Int)

Product Public Reason for Recall 

(Int)

Potential to contain undeclared egg Field Recommended Classification 

Class I 

Center Determination/Classification

(Int)

Center Recommended Depth 

Product Effectiveness Check Level 

A Percent 100 Product Audit Check Level 

E Percent 0 Code Information (Int)

(b) (4) (b) (4)
Best by dates through 10/28/2020 Expected Life 

Shelf Life 

10/28/2020 CFSAN Reason 

Recalling Firm Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Most Responsible Individual

Official's Name John Mackey 

Title President 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 512-542-2200 Ext Country Code

Facsimile Ext Country Code

E-mail Address john.mackey@wholefoods.com

Comment 

Manufacturer Information

FEI 3007331558 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code
Comment 

Responsible Firm Information

FEI 3007331558 

Firm Type Manufacturer 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Comment 

Recall Contact

Official's Name Craig Penigar 

Title Global Incident Management 

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone 512-542-2200 Ext Country Code

Facsimile Ext Country Code

E-mail Address craig.penigar@wholefoods.com

Comment 

Public Contact

Official's Name 

Title

Firm Name (Int) Whole Foods Market 

Address (Int) 550 Bowie St 

City (Int) Austin 

State/Province (Int) Texas 

Country (Int) United States 

Postal Code (Int) 78703-4644 

Telephone Ext Country Code

Facsimile Ext Country Code
E-mail Address 

Comment 1-844-936-8255 between the hours of 7:00 a.m. and 10:00 p.m. CST, Monday through Friday, or 8:00 a.m. 

and 6:00 p.m. Saturday through Sunday. 

Summary Help 

WARNING! Sensitive/critical information. This information is proprietary and confidential. It should not be disclosed to unauthorized parties and 

should be maintained in a secure environment. 

Printed by: Tyra S. Wisecup 

Recalls 13.5 | Copyright 2019 | U.S. Food and Drug Administration