What this is
What is a recall plan?
What is a recall plan?
A documented plan setting out who decides a recall, on what basis, how affected product is identified and located, who is notified and within what timescales, how product is recovered and reconciled, and how the recall is closed and reviewed.
What is the difference between a recall and a withdrawal?
A withdrawal removes product from the supply chain before it reaches consumers. A recall extends to product that may already be with consumers and generally involves public notification. The distinction affects the notification obligations and the speed required, and the decision between them is one the plan should address explicitly.
Scope
When is a recall plan required?
The plan covers the whole response. Several supporting capabilities are separate and are what the plan depends on.
Use this template when
- Defining the decision authority, escalation and out-of-hours reachability
- Setting out classification, notification obligations and timescales by jurisdiction and customer
- Documenting how affected product is identified, located, recovered and reconciled
- Planning and recording mock recalls and traceability exercises
- Reviewing after a real event, a mock exercise or a change in customers, markets or products
Do not use it for
- The traceability system itself, which the plan relies on and which is tested separately
- Crisis communications and media handling, which is broader and sits alongside
- The complaint and incident processes that may trigger a recall
- Product disposition and destruction records, generated during the response
- Insurance and legal notification, which follows its own requirements
Compliance mapping
Which FSMA requirements does this satisfy?
Recall obligations combine a written plan requirement, reporting duties with their own clocks, and scheme testing expectations.
| Clause | Requirement | Where it lands |
|---|---|---|
| 21 CFR 117.139 | Written recall plan where a hazard requires a preventive control, with notification, public warning, effectiveness checks and disposition | Header |
| 21 CFR 1.900 series | Reportable Food Registry submission within 24 hours of determining a food is reportable | Classification and decision |
| FSMA section 206 | FDA mandatory recall authority where a responsible party fails to voluntarily recall | Classification and decision |
| 21 CFR 1 Subpart S | Additional traceability records for foods on the Food Traceability List | Traceability and notification |
| 9 CFR 418 | Recall procedures and notification requirements for meat and poultry establishments | Recovery and closure |
| SQF Edition 9 cl.2.6 | Product trace, withdrawal and recall with testing at defined frequency | Testing |
| BRCGS Issue 9 cl.3.11 | Product withdrawal and recall procedures tested at least annually | Testing |
| EU Reg 178/2002 art.19 | Withdrawal and recall obligations and notification of competent authorities | Traceability and notification |
What it does not cover
- The traceability system, which the plan depends on and which is exercised separately.
- Crisis communications, which is broader and includes media, customers and staff.
- Complaint and incident processes, which may generate the trigger.
- Disposition and destruction records, generated during a response.
- Insurance and legal notification, following its own requirements and timescales.
How to complete it
How to complete a recall plan, step by step
Name who decides, rehearse the decision, and test the trace on a batch that is difficult.
One named person with authority to initiate, a named deputy, and contact details that work at 11pm on a Sunday. Recalls are discovered outside office hours more often than inside them, and a plan naming a job title rather than a person with a mobile number has not answered the question.
Construct a scenario with partial information, commercial pressure and a plausible case for waiting. Give it to the actual decision maker with the actual data available at that point. This is the step that fails in real events, and it is almost never exercised because mock recalls begin after the decision has been made for them.
Choose a batch involving rework, blending, partial shipment or repacking. Clean batches test the straightforward path, and the complicated cases are where lineage breaks and where a real recall will land. Set a time limit and observe how the answer is assembled.
Customers, distributors, authorities, laboratories, the certification body and internal escalation. Contact lists decay faster than any other part of a recall plan, and the discovery that a key number is three years out of date happens during the event. Verify them on the same cycle as the test.
What auditors find
Most common recall plan findings
Recall findings concentrate on what the testing did not cover.
| Finding | Clause | What fixes it |
|---|---|---|
| Mock recall begins from a supplied batch code, skipping the decision. | SQF 2.6 | Rehearse the decision with ambiguous information and commercial pressure. |
| Decision authority named by job title with no out-of-hours contact. | 21 CFR 117.139 | Name people and numbers that work at night and at weekends. |
| Traceability exercises always performed on clean batches. | BRCGS 3.11 | Test with rework, blending or partial shipment in the batch. |
| Contact lists not verified between exercises. | 21 CFR 117.139 | Verify on the same cycle as the test; lists decay faster than procedures. |
| Reportable Food Registry obligation not built into the response. | 21 CFR 1.900 series | The 24-hour clock runs from determining the food is reportable and is separate from the recall. |
| No effectiveness checks defined for recovery. | 21 CFR 117.139 | Define how you confirm that customers received and acted on the notification. |
| Mass balance not reconciled at the end of the exercise. | SQF 2.6 | Reconcile quantities; an unreconciled trace has not established the boundary. |
| Plan not updated after a change of customers, markets or distribution. | BRCGS 3.11 | New markets bring different notification obligations and different timescales. |
| Exercise conducted during the working day only. | SQF 2.6 | Test out of hours at least once; that is when real events start. |
| Foods on the Food Traceability List without the additional records required. | 21 CFR 1 Subpart S | Check whether products are listed; the record requirements are additional and specific. |
Case in point
Case in point: the exercise that started too late
A manufacturer ran two mock recalls a year, both completed within the four-hour target. The exercises began with a batch code supplied by the quality manager and ended when quantities reconciled. Results were reported to management and to the certification body as evidence of a robust system.
A real event began on a Friday evening with a customer reporting a complaint that might have indicated a process failure, or might have been a single damaged pack. The named decision maker was on leave, the deputy was not listed with a mobile number, and the information available did not clearly support either recalling or not recalling.
Product moved for a further eleven hours while the site sought more information. The traceability system, when eventually used, produced the answer in under two hours exactly as the exercises had shown.
The template
The template, field by field
The form exactly as it installs. Every field, option, score and conditional rule is editable, and the links to other templates come with it.
6 sections
- Reference
- QUA-055
- Archetype
- Plan
- Record ID
- RCL-2026-000
- Scoring
- Not scored
- Direction
- n/a
- Singleton
- No
- Basis
- FSMA, SQF 2.6
- Links
- Links Traceability
- Tags
- Food safety, Recall
- Sections
- 6
- Fields
- 49
- Follow up fields
- 3
- Repeating sections
- 0
- Links out
- 4
Header
11 fieldsPlan ID*
Auto sequence. Format RCL-2026-000.
The record's own ID. Other templates point at this value.
Status*
Drives who this goes to next.
- Planned2 pts
- In progress2 pts
- Complete3 pts
- Deferred0 pts
- Open0 pts
- Closed3 pts
- Overdue0 pts
Version*
Issue Date*
Next Review Due*
Site*
Site ID*
Format SITE-000.
Links to FDN-001 Site ID
Recall Coordinator*
Deputy Coordinator*
Available 24 Hours*
- Yes3 pts
- No0 pts
The Clock Starts Immediately
A recall decision is usually made within hours of first knowledge. Everything in this plan exists so that decision can be made with facts rather than guesses.
Team and authority
6 fieldsRecall Team Named*
- Yes3 pts
- No0 pts
Roles Defined*
- Yes3 pts
- Partly1 pt
- No0 pts
Decision Authority Defined*
- Yes3 pts
- No0 pts
Team Contactable Out Of Hours*
- Yes, tested3 pts
- Assumed1 pt
- No0 pts
Deputies Named For Every Role*
- Yes3 pts
- Partly1 pt
- No0 pts
Team Trained*
- Yes3 pts
- Partly1 pt
- No0 pts
Classification and decision
5 fieldsRecall Classes Defined*
Class 1 health risk, class 2 possible risk, class 3 no risk. Withdrawal versus recall must also be distinguished.
- Yes3 pts
- No0 pts
Withdrawal Versus Recall Defined*
- Yes3 pts
- No0 pts
Decision Criteria Documented*
- Yes3 pts
- No0 pts
Risk Assessment Method Defined*
- Yes3 pts
- No0 pts
External Expertise Identified
- Yes3 pts
- No1 pt
Traceability and notification
8 fieldsTraceability System Identified*
- Yes3 pts
- No0 pts
Target Trace Time Hours*
Customer Contact List Current*
- Yes, verified3 pts
- Assumed current1 pt
- No0 pts
Regulator Contacts Listed*
- Yes3 pts
- No0 pts
Notification Templates Prepared*
- Yes3 pts
- No0 pts
Press Statement Template Prepared*
- Yes3 pts
- No1 pt
Consumer Notification Route Defined*
- Yes3 pts
- No0 pts
Point Of Sale Notice Prepared
- Yes3 pts
- No1 pt
Recovery and closure
6 fieldsProduct Return Route Defined*
- Yes3 pts
- No0 pts
Quarantine Location Defined*
- Yes3 pts
- No0 pts
Disposal Method Defined*
- Yes3 pts
- No0 pts
Effectiveness Check Defined*
How you will know what percentage was actually recovered.
- Yes3 pts
- No0 pts
Root Cause Investigation Required*
- Yes3 pts
- No0 pts
Recovery Target Percent
Testing
13 fieldsPlan Tested In Last 12 Months*
- Yes3 pts
- No0 pts
Last Mock Recall ID
Links to QUA-056 Record ID
Next Test Due*
Plan Document
Document ID
Format DOC-0000.
Links to FDN-008 Document ID
Action Required*
Raise the action record, then enter its reference here.
- No2 pts
- Yes0 pts
Priority
- High0 pts
- Medium1 pt
- Low3 pts
CAPA ID
Format CAPA-2026-00000.
Links to FDN-014 CAPA ID
Action Owner
Recall Coordinator*
Signature*
Site Manager*
Second Signature*
QUA-055 · record IDs look like RCL-2026-000 · Links Traceability
Open in KnowellaRun it with agents
From a document you fill in to a programme that runs itself
The plan governs a response nobody wants to run. What fails is the decision nobody rehearsed and the contact list nobody checked.
Holds the plan with named decision authority and deputy, runs exercises including decision scenarios, and verifies contact lists on each cycle.
Executes the trace across shipments and distribution, including rework and partial consignments where lineage is hardest.
Watches complaints and out-of-specification results for patterns that should trigger the decision earlier than a single report would.
Tracks notification obligations and timescales by jurisdiction and customer, including registry submissions with their own clocks.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Meet KnowQuality→Glossary
Recall Plan definitions and key terms
- Recall
- Removal of product from the market, extending to product that may have reached consumers, generally involving public notification.
- Withdrawal
- Removal of product from the supply chain before it reaches consumers, with narrower notification requirements.
- Reportable food
- Food for which there is a reasonable probability of serious adverse health consequences, triggering a 24-hour registry submission in the US.
- Mock recall
- A rehearsal of the recall process, usually testing traceability and rarely testing the decision.
- Effectiveness check
- Confirmation that those notified received the notification and took the required action.
- Mass balance
- Reconciliation of quantities produced, shipped, held and recovered, which establishes whether the trace is complete.
- Food Traceability List
- The FDA list of foods subject to additional traceability record requirements under 21 CFR 1 Subpart S.
- Decision authority
- The named individual empowered to initiate a recall, with a named deputy and out-of-hours contact.
FAQ
Frequently asked questions about recall plan
What does a mock recall usually fail to test?+
The decision. Exercises typically begin with a batch code supplied by the organiser and measure how long reconciliation takes, which tests the traceability system. Real events begin with ambiguous information arriving at an inconvenient time with commercial consequences attached, and that is the step where product continues to move while the organisation seeks more certainty.
How should we make the exercise more realistic?+
Give the actual decision maker a scenario with partial information and a plausible argument for waiting, out of hours, and observe what happens. Separately, run traceability tests on batches involving rework, blending or partial shipment rather than clean ones, because the complicated cases are where lineage breaks and where a real event will land.
What does FSMA require in a recall plan?+
Where a hazard requires a preventive control, a written recall plan with procedures to notify direct consignees, notify the public where necessary to protect public health, conduct effectiveness checks, and appropriately dispose of recalled food. Separately, the Reportable Food Registry requires submission within 24 hours of determining that a food is reportable, which is a distinct clock.
How often should we test?+
At least annually under most schemes, and more frequently where products, customers, markets or distribution change. Frequency matters less than variety: several exercises of the same type demonstrate the same thing repeatedly, while varying the trigger, the batch complexity and the time of day tests different failure points.
What decays fastest in a recall plan?+
Contact lists. Customers, distributors, authorities, laboratories and internal escalation contacts all change, and the discovery that a critical number is years out of date reliably happens during a real event. Verifying the list should be part of every exercise rather than an annual administrative task.
Keep going
Related templates and programmes
Industries this is written for
Programmes this belongs to
Used together in HACCP and Food Safety
Unannounced Audit Readiness Check
Checks whether the site would pass an audit arriving today, covering records, standards and area condition
Product Nonconformance Report
Records product that does not meet specification
Hold and Release Record
Places suspect product on hold and records the decision to release, rework or scrap it
HACCP Plan
The hazard analysis and critical control point plan for a product or process
HACCP Verification Record
Confirms the HACCP plan is being followed and still works
CCP Monitoring Log
Records readings at a critical control point, such as cook temperature, chill time or metal detection
More in Food Safety
HACCP Plan
The hazard analysis and critical control point plan for a product or process
HACCP Verification Record
Confirms the HACCP plan is being followed and still works
CCP Monitoring Log
Records readings at a critical control point, such as cook temperature, chill time or metal detection
Prerequisite Programme Plan
Sets out the basic conditions that must be in place for HACCP to work, covering hygiene, maintenance, pest control and training
Allergen Control Plan
Sets out how allergens are managed from receipt through to labelling, including segregation and changeover
Allergen Changeover Check
Confirms the line is clear of the previous allergen before the next product runs
Written and reviewed by
Siddarth Singh
Founder & Chief Executive Officer, Knowella
Certified Safety Professional and industrial and systems engineer with more than a decade inside food supply chain, freight and manufacturing operations. This page was written against the current text of the standards it cites, not against secondary summaries of them.
- Certified Safety Professional (CSP), Board of Certified Safety Professionals
- MBA, University of Chicago Booth School of Business
- MS and BS, The Ohio State University, Industrial and Systems Engineering
- Six Sigma Black Belt
Sources and last review. Reviewed 16 August 2026 against:
- 21 CFR 117.139, recall plan, FDA
- 21 CFR Part 1 Subpart H and the Reportable Food Registry requirements, FDA
- 21 CFR Part 1 Subpart S, additional traceability records for foods on the Food Traceability List, FDA
- 9 CFR Part 418, recalls, USDA FSIS
- SQF Edition 9 clause 2.6 and BRCGS Food Safety Issue 9 clause 3.11
This page is general guidance, not legal advice. Confirm requirements with your jurisdiction’s regulator.