Food Recall Process Workflow

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Food Recall Process - Removing Unsafe Food From the Market

A facility with food that has a hazard requiring a preventive control must have a written recall plan that assigns responsibility for notifying direct consignees, alerting the public when needed, checking that the recall is effective, and disposing of the recalled food. When a recall is needed, the firm evaluates the health hazard, sets a recall strategy, notifies FDA and consignees, carries out effectiveness checks, reports status, and requests termination. This map follows the pathway from preparation through decision, notification, and effectiveness verification.

21 CFR 117.139 · 21 CFR Part 7 Subpart C · FD&C Act Section 423

21 CFR 117.139

21 CFR 7 Subpart C

Recall Plan

Class I Recall

A reasonable probability that use of or exposure to the food will cause serious adverse health consequences or death.

Basis: Highest hazard

Class II Recall

Use of or exposure to the food may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Basis: Moderate hazard

Class III Recall

Use of or exposure to the food is not likely to cause adverse health consequences.

Basis: Lowest hazard

Effectiveness Checks

Verification that consignees received the recall notice and took the required action, at a level suited to the hazard.

Basis: Levels A to E

Phase 1

Preparation and Readiness

1Establish the written recall plan

Procedures to notify direct consignees, alert the public when needed, check effectiveness, and dispose of recalled food.

21 CFR 117.139

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2Assign the recall team and responsibilities

Named people responsible for each action, with authority to decide and a contact available when needed.

21 CFR 117.139(b) · 7.59

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3Maintain coding and distribution records

Every unit carries a lot code, and distribution records allow positive lot identification and fast consignee lists.

21 CFR 7.59

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4Test the plan

Mock recalls reconcile quantities made, shipped, and held, and expose gaps before a real event.

21 CFR 7.59

Phase 2

Decision and Strategy

Is the food possibly adulterated or misbranded in a way that could harm consumers?

YES → Initiate the recall NO → Document the evaluation and monitor

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5Identify the problem and affected lots

The source, such as a complaint, test result, supplier notice, or inspection finding, and every lot that could be affected.

21 CFR 7.40

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6Conduct a health hazard evaluation

Illness or injury already occurred, populations at risk, seriousness, likelihood, and consequences weighed and documented.

21 CFR 7.41(a)

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7Notify FDA and set the recall strategy

Depth of recall, need for public warning, and effectiveness check level decided, and FDA notified without delay.

21 CFR 7.42 · 7.46

Phase 3

Notification and Execution

8Notify direct consignees

Prompt notice identifying the product and lot codes, the reason and hazard, and clear instructions and a way to respond.

21 CFR 117.139(b) · 7.49

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9Alert the public when needed

Public warning issued where other means of preventing use appear inadequate, and FDA may publish the recall.

21 CFR 117.139(b) · 7.42 · 7.50

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10Receive, segregate, and account for food

Returned food held apart, counted, and reconciled against quantities distributed, then reprocessed, diverted, or destroyed.

21 CFR 117.139(b)

Phase 4

Effectiveness and Termination

11Conduct effectiveness checks

Consignees contacted at the chosen level to confirm notices were received and action taken.

21 CFR 117.139(b) · 7.42

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12Submit recall status reports

Regular reports to FDA on consignees notified, responses, food returned, and expected completion.

21 CFR 7.53

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13Request termination and reanalyze

Termination requested with the final report and disposition, and the food safety plan reanalyzed for the cause.

21 CFR 7.55 · 117.170

Recall Strategy Elements (Overview)

Depth of Recall

Wholesale, retail, or consumer level, depending on the hazard and how far the food has been distributed.

21 CFR 7.42

Public Warning

Reserved for urgent situations where other means of preventing use of the food appear inadequate. It can be general or targeted.

21 CFR 7.42 · 7.50

Effectiveness Check Levels

Level A checks 100% of consignees, Level B more than 10% and less than 100%, Level C 10%, Level D 2%, and Level E none.

21 CFR 7.42

Health Hazard Evaluation Factors (Overview)

Illness or injury already occurred Whether disease or injuries have already been associated with the food, and whether conditions could contribute to harm.

Populations at risk Hazard to different consumer groups, with attention to those at greatest risk, such as infants or the immunocompromised.

Seriousness and likelihood How severe the harm could be and how likely it is to occur from consumption.

Immediate or long-range consequences Whether the harm shows up quickly or over time, and whether it can be reversed.

Key Recall Outputs (Overview)

Written recall plan Procedures and responsibilities for notification, public warning, effectiveness checks, and disposition.

Health hazard evaluation and strategy The reasoning for the recall decision, depth, public warning, and effectiveness check level.

Consignee notices and responses Copies of notices, the list of recipients, and records of their responses and actions.

Status reports and termination request Reports to FDA, the final reconciliation, and the disposition of recalled food.

Recall Quality Elements

Written Plan A plan that covers every required action and that people have actually read.

Defined Roles Named people with authority to decide, plus alternates for nights and weekends.

Positive Lot Identification Lot coding and distribution records that let you say exactly which units went where.

Fast Decision Making A clear way to move from a suspected problem to a health hazard evaluation and a decision.

Clear Communications Notices that say what the food is, why it is being recalled, and exactly what to do.

Reconciliation Quantities made, shipped, returned, and destroyed reconciled so nothing goes unaccounted.

Effectiveness Verification Checks that confirm the recall reached the people it needed to reach.

Learning After Recall Root cause investigation and reanalysis of the food safety plan after every recall.

Never do this

Wait for complete information before telling consignees. Ship food without lot codes. Skip the health hazard evaluation. Let returned food mix with saleable stock. Close a recall without effectiveness checks or a reconciliation.

Voluntary vs FDA-requested vs mandatory

A recall is generally voluntary. FDA may request one in urgent situations, and under FD&C Act Section 423, FDA can order a mandatory recall in specified serious cases where a responsible party does not act. Firms are expected to act promptly instead of waiting to be told.

Recall vs market withdrawal

A recall removes or corrects food that FDA considers in violation and subject to legal action. A market withdrawal is a removal for a minor violation that FDA would not act on, or no violation at all. The distinction affects reporting, so confirm it with regulatory counsel or FDA.

Key regulations

21 CFR 117.139 - recall plan. 21 CFR Part 7 Subpart C - recall policy, health hazard evaluation, strategy, communications, status reports, and termination. FD&C Act Section 423 - mandatory recall authority. 21 CFR 117.150 and 117.170 - corrective action and reanalysis after a recall.