A product recall is the real thing: removing or correcting a product that's on the market because it may be unsafe or breaks the law, with customers told, FDA usually informed, and the product brought back or destroyed. A mock recall is a practice run of the same trace: you pick a lot, find every unit of it and everything that went into it, time yourself, and call a couple of customers to check the numbers work, but nothing leaves the shelves and nobody outside is told it's real. The mock recall is how you find out your records have a gap before a real recall finds it for you.
The short version
- Recall: real product, real risk, real customers told. Mock recall: the same trace, as a drill.
- FDA's rules define recalls and require a written recall plan for many food facilities. "Mock recall" comes from buyers and audit schemes, not FDA's rules.
- A mock recall tests the trace (records), the contact list (phones) and the plan (who does what).
- Time it, reconcile it to 100%, write down what went wrong, and fix it.
- TaroStack runs the trace as one report and logs timed drills, so the practice and the real thing use the same tool.
What FDA means by a recall
FDA's definitions, in 21 CFR 7.3:
| Term | Meaning |
|---|---|
| Recall | A firm's removal or correction of a marketed product that FDA considers in violation of the laws it administers and against which it would take legal action, such as seizure |
| Market withdrawal | Removal or correction of a distributed product for a minor violation, or none, such as normal stock rotation |
| Stock recovery | Removal or correction of product that hasn't left the firm's direct control |
| Correction | Repair, relabeling, destruction or inspection of a product without moving it elsewhere |
Recalls are classed by hazard: Class I where there's a reasonable probability the product will cause serious adverse health consequences or death; Class II where it may cause temporary or medically reversible effects, or serious ones are remote; Class III where it's not likely to cause adverse health consequences (21 CFR 7.3).
A firm that removes a product because it believes it's violative is asked to notify its FDA district office immediately, with the product, the reason, the amounts made and in distribution, the customers, and the proposed communication (21 CFR 7.46), and it's responsible for promptly notifying each affected direct account (21 CFR 7.49).
For food with a hazard requiring a preventive control, the preventive controls rule requires a written recall plan with the steps and who takes them: notify direct customers, notify the public when appropriate, check that the recall worked, and dispose of the food (21 CFR 117.139). A filled-in example is in the recall plan example.
The rules don't use the words "mock recall". Buyers and food safety audit schemes do, which is why it shows up on vendor forms. This is general information, not legal advice; FDA and your auditor have the last word.
Side by side
| Mock recall | Product recall | |
|---|---|---|
| Starts with | A lot you choose, on a day you choose | A real problem: a supplier's notice, a complaint, a test result, FDA |
| The product | Stays where it is | Is held, brought back, corrected or destroyed |
| Customers | Two or three called to check contact details | Every affected customer notified, with instructions |
| FDA | Not involved | Usually notified, and sometimes involved throughout |
| The public | Not told | Told when that's needed to protect health |
| Cost | A couple of hours | Lost product, refunds, freight, time, and trust |
| What it proves | Your records and contacts work | Whether they did |
The same lot, practiced and then real
Windward Roots, the made-up taro business I use in these examples, ran a mock recall on its coconut oil lot CO-0910 on a quiet Wednesday. It took 80 minutes: the receiving log, two chip batches, five customer shipments, and the oil reconciled to the liter (40 L received; 34 used, 4 on hand, 2 spilled). Two things went wrong: online orders took six minutes to find, and the gift shop had only one phone number on file. Both were fixed that week.
Now suppose the oil supplier calls three weeks later about that lot. The trace is the same trace, already rehearsed. What's new is everything around it: the chip batches are put on hold, the coordinator decides whether it's a recall, the supplier and FDA are told, customers get a written notice saying what to stop selling and what to do with it, the products come back or are destroyed, and someone checks each customer actually acted. The mock recall did the hardest part in advance: knowing within an hour exactly which batches and customers are involved. How to run one, with a form, is in the mock recall and traceability exercise, and the worked drill is in a food mock recall example.
How often to run one
Once a year is a sensible starting point, and buyers and audit schemes set their own. I'd also run one after any big change: a new product, a new supplier, a new person doing the records, or a move to new software. And vary it: start from a finished lot one time, an ingredient lot the next, and pick a lot from a busy week, not a quiet one.
Where this stops working
A mock recall on paper takes a few people a morning, because the trace runs through four sets of records that weren't made to fit together: receiving logs, batch sheets, packing records and invoices. That's why they get put off. And when they're put off, the first real test of the records is the real recall, which is the worst possible time to find that one batch sheet didn't list its ingredient lots.
How TaroStack does it
In TaroStack, the mock recall and the real one are the same report, so practicing costs minutes. Receiving records each supplier lot, recording a batch notes which lots it used, and shipping puts the lot on each order, so picking lot CO-0910 gives you the batches it went into, the customers who received them with quantities, what's still on your own shelves, and who to call. Drills are built in: start one, the clock runs, and the result is logged with the time it took, which is the date and the minutes for the buyer's form.
When it's real, the same report is your call list, and putting the affected stock on hold keeps it out of what can be sold or shipped while you decide. Returns go back into the lot they left in, so you can see what came back against what went out. TaroStack doesn't decide whether to recall or contact FDA for you; it makes sure the list you're working from is right.
Lots, expiry and recalls are on every plan, from $49 a month, and recording batches against recipes is on Standard at $99. The first 30 days are free. If you'd like a hand setting up, ask, and we'll do it with you.