# Recall / Withdrawal Plan

The standing plan you activate when product has to come back: who runs the recall,
how you decide a recall from a market withdrawal, who you notify, how you get the
product back, and how you confirm it worked. Fill it in now, while nothing is on
the line, so you are never writing this plan for the first time during a real event.

The first thing the plan settles is which event you are running. FDA draws the line
in 21 CFR 7.3: a recall handles a marketed product FDA considers violative and could
take legal action against, such as seizure; a market withdrawal handles a distributed
product with a minor violation FDA would not act on, or no violation at all. Same
team, same trace — different obligations, so the decision belongs in writing.

Test the plan on a schedule. SQF Edition 9 requires you review and test the
withdrawal and recall procedure at least once a year, and again after any change that
would affect it. The trace itself lives in a separate exercise — a mock-recall log is
where you run it. Fill every blank, keep the contacts current, and put a copy where
your team can reach it without a login or a locked office.

- Recall vs. market withdrawal, and the recall classes, 21 CFR 7.3: https://www.law.cornell.edu/cfr/text/21/7.3
- Recall strategy — depth of recall and effectiveness checks, 21 CFR 7.42: https://www.law.cornell.edu/cfr/text/21/7.42
- Firm-initiated recall and notifying FDA, 21 CFR 7.46: https://www.law.cornell.edu/cfr/text/21/7.46
- FSMA Food Traceability Rule (FSMA 204), compliance date July 20, 2028 as of July 2026: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods
- SQF Food Safety Code, Edition 9: https://www.sqfi.com/our-program/certification-programs/food-safety-program

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## Plan header

Identify the plan and record when it was last proven current.

| Field | Entry |
| --- | --- |
| Facility | |
| Plan owner (name, role) | |
| Version / revision | |
| Last reviewed and tested | |
| Next review due | |

## Recall team and contacts

Name a coordinator who can act around the clock, a backup for every role, and the
outside people you would have to reach in the first hour. Fill in real names and
direct numbers, not a main line.

| Role | Name | Responsibility in a recall | Phone (24/7) | Backup |
| --- | --- | --- | --- | --- |
| (example) Recall coordinator | ____ | Leads the plan, makes the recall-or-withdrawal call | ____ | ____ |
| QA / food safety lead | | Health hazard evaluation, records, disposition | | |
| Operations / production lead | | Locates and holds affected lots | | |
| Sales / customer contact | | Notifies and follows up with customers | | |
| Communications | | Handles public warning and media, if needed | | |
| Owner / executive sponsor | | Authority to commit the company | | |

The outside contacts you may have to reach. Confirm the direct line for your FDA
district office and your certification body before you ever need it.

| Contact | Organization | When you reach them | Phone | Email |
| --- | --- | --- | --- | --- |
| (example) FDA district recall coordinator | FDA | When the event is a recall, not a withdrawal | ____ | ____ |
| Certification body + SQFI | | Within 24 hours of a recall (see below) | | foodsafetycrisis@sqfi.com |
| Legal counsel | | Before public notification | | |
| Insurer / product-liability carrier | | When the event is opened | | |
| Testing laboratory | | To confirm or rule out the hazard | | |
| Key co-manufacturer or 3PL | | If they hold or made affected lots | | |

## Decision: recall or market withdrawal?

One decision drives everything after it. Record which event you are running and why,
using the line FDA sets in 21 CFR 7.3.

| The situation | The event |
| --- | --- |
| Product violates a law FDA administers, and FDA could take legal action such as seizure | Recall |
| Minor violation FDA would not act on, or no violation at all | Market withdrawal |
| Fixed without moving the product — relabel, rework, or destroy in place | Correction (can accompany either) |

If it is a recall, classify it by health hazard. FDA's three classes in 21 CFR 7.3
set how serious the risk is, which drives how deep the recall reaches and whether the
public is warned.

| Class | What it means |
| --- | --- |
| Class I | Reasonable probability that use or exposure will cause serious adverse health consequences or death |
| Class II | Use or exposure may cause temporary or medically reversible consequences, or serious consequences are remote |
| Class III | Use or exposure is not likely to cause adverse health consequences |

Record the decision. This is the record an auditor or FDA will ask to see.

| Field | Entry |
| --- | --- |
| Date and time of decision | |
| What was found (hazard, defect, or complaint) | |
| Lots and products affected | |
| Event — recall or market withdrawal? | |
| If a recall, class (I / II / III) | |
| Basis for the decision | |
| Decided by (name, role) | |

## Notification list

Who you tell, in what order, and on what clock. Your customer list is the forward
trace: every direct customer an affected lot shipped to — one step forward. The
traceability records the FSMA Food Traceability Rule (FSMA 204) asks for are what make
that list fast to pull; confirm the current compliance date on FDA's page, which as of
July 2026 is July 20, 2028.

| Who to notify | Contact / how | What you tell them | Deadline | Notified (date, time) |
| --- | --- | --- | --- | --- |
| (example) Affected direct customers | From your forward trace | Lot, reason, action to take, how to return | ____ | ____ |
| Certification body + SQFI | In writing | That a recall (or public incident) is open | Within 24 hours | |
| FDA district recall coordinator | Direct line | Product, reason, risk, amounts, distribution, your recall strategy, a contact | Immediately, if a recall | |
| Broker or distributor | | To pass notice down their accounts | | |
| Internal team and floor | | Quarantine affected lots now | | |

Two clocks live in that table, and they are not the same. The 24-hour written notice
to your certification body and SQFI is a real SQF requirement, and 21 CFR 7.46 asks a
firm running its own recall to notify the appropriate FDA district office immediately.
But SQF sets no fixed time limit for completing the trace itself — the "trace in 2 to 4
hours" bar operators cite is a customer and industry expectation, not a line in the
code. Put your own customers' real deadlines in that column.

## Product retrieval and disposition

Decide how far down the chain the recall reaches — the depth of recall: to the
consumer or user level, the retail level, or the wholesale level only — then get the
product back, hold it apart, and decide what happens to it. 21 CFR 7.42 frames the
depth choice by how serious the hazard is and how far the product spread.

| Field | Entry |
| --- | --- |
| Depth of recall (consumer/user, retail, or wholesale) | |
| Where recovered product is quarantined | |
| Who authorizes final disposition | |

Track every affected lot from where it sits now to what finally happens to it. Hold
recovered product on QA hold so it cannot ship again by mistake.

| Lot / product | Where it is (customer, warehouse, in transit) | Quantity | Retrieval action | Disposition (return, destroy, rework/relabel) | Record reference |
| --- | --- | --- | --- | --- | --- |
| (example) SKU-104 lot 240612 | 3 distributor DCs | 180 cases | Pickup arranged | Destroy, witnessed | ____ |
| | | | | | |
| | | | | | |
| | | | | | |

## Effectiveness check

A recall is not finished when you send the notice — it is finished when you confirm
each customer received it and acted. Run an effectiveness check — the verification that
each consignee received the recall notice and took the action it called for — at the
coverage level the hazard warrants. 21 CFR 7.42 sets the levels.

| Level | Consignees you verify |
| --- | --- |
| A | 100% |
| B | More than 10%, less than 100% |
| C | 10% |
| D | 2% |
| E | None |

| Field | Entry |
| --- | --- |
| Effectiveness-check level chosen (A–E) | |
| Basis for the level | |

Log each check as you make it.

| Consignee | Contacted (date) | Confirmed received notice? | Product secured or returned? | Quantity recovered | Follow-up needed |
| --- | --- | --- | --- | --- | --- |
| (example) Harbor Foods Distribution | ____ | Y | Y | 140 cases | Await 40 in transit |
| | | | | | |
| | | | | | |
| | | | | | |

## Sign-off and review

The plan is only real when someone accountable owns it and it gets tested. Review and
test at least once a year, and again after any change to your products, customers,
suppliers, or process.

| Field | Entry |
| --- | --- |
| Plan approved by (name, role) | |
| Approval date | |
| Last tested (mock recall or real event) | |
| Result — plan effective? (Y / N) | |
| Gaps to fix | |
| Next test due | |