Product Recall Response: First Decisions, Notification and Effectiveness Checks
Investigation, decision, notification, retrieval and proof it worked, all at once. One timeline and one decision log keep it together.
In Short
- Start one timeline and decision log at the first report.
- Each regulator has its own procedure; know them before you need them.
- Close only when quantities reconcile and effectiveness is checked.
Inventory & Traceability: the Practical Operations Guide
From goods-in to dispatch: practical controls for locations, usable stock, movements, counting, picking and traceability. Use it with or without V5.
- Follow a lot both ways.
- Reconcile a trace before acting on it.
- Run a timed trace exercise.
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Inventory & Traceability: the Practical Operations Guide
From goods-in to dispatch: practical controls for locations, usable stock, movements, counting, picking and traceability. Use it with or without V5.
A recall runs several workstreams at once: investigation, decision, regulator notification, customer communication, product retrieval and effectiveness checks. This playbook sets out how to coordinate them, with pointers to each regulator's own procedure. It is a planning aid, not legal advice; reporting duties and times depend on the product and the market.
The First Decisions
Start a single timeline and decision log. Confirm what is known and assess the health risk with qualified people.
More on the First Decisions
Use traceability records to identify affected lots, quantities and customers, and place stock you control on hold. The authorised decision-makers named in your plan decide whether to recall, withdraw or take no market action, and record their reasons. Regulators may classify the recall; in the US, FDA assigns class I, II or III under 21 CFR Part 7.
Notifying Regulators
United States: contact FDA's recall coordinator for your division; food, drug, device and cosmetic rules differ, and device corrections and removals have a 10-working-day report under 21 CFR Part 806. United Kingdom: medicines defects are reported to the MHRA, and devices through its reporting routes.
Where to start, by market
Pointers to each regulator's own procedure.
- 21 CFR Part 7 recall policy.
- Devices: reportable corrections/removals within 10 working days of starting (Part 806).
More on notifying Regulators
Canada: Health Canada and the Canadian Food Inspection Agency have their own recall procedures. EU: national competent authorities handle recalls, with rapid-alert systems for some products. Australia: the TGA's Procedure for Recalls, Product Alerts and Product Corrections (PRAC, which replaced the earlier Uniform Recall Procedure) applies to therapeutic goods. Check each procedure for current requirements before you need it.
Customer, Consumer and Channel Communication
Tell each recipient exactly which product and lots are affected, how to identify them, what to do and how to confirm. Under 21 CFR 7.49, FDA expects recall communications to be clear and to ask recipients to respond.
More on customer, Consumer and Channel Communication
Use templates prepared in advance and approved by the people named in your plan. Keep one record of who was contacted, when and how they responded.
Effectiveness Checks and Close-Out
Check that recipients received the notice and acted. 21 CFR 7.42 describes effectiveness-check levels, from contacting all consignees to none.
FDA effectiveness-check levels (21 CFR 7.42)
| Level | Who is checked |
|---|---|
| A | All consignees |
| B | More than 10% and fewer than all, set case by case |
| C | 10% of consignees |
| D | 2% of consignees |
| E | No effectiveness checks |
- A
- Who is checked
- All consignees
- B
- Who is checked
- More than 10% and fewer than all, set case by case
- C
- Who is checked
- 10% of consignees
- D
- Who is checked
- 2% of consignees
- E
- Who is checked
- No effectiveness checks
More on effectiveness Checks and Close-Out
Reconcile shipped, returned, corrected and destroyed quantities. Provide status reports where required, then request termination when the regulator's criteria are met. Complete the root-cause investigation and CAPA and update the plan.
Questions
When should we start a voluntary recall rather than wait for the regulator?
When your assessment shows a product presents a risk or is in violation, act promptly under your plan. Most recalls are firm-initiated. Discuss with the regulator early.
Can we recover recall costs from suppliers or insurance?
Possibly, depending on your contracts and insurance policy. Keep full records of costs and decisions from the start.
How long does a recall stay open?
Until the regulator's termination criteria are met, which depends on effectiveness checks and reconciliation. There is no fixed period.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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