Voluntary Recall vs Mandatory Recall: How Food Recalls Start

Almost every food recall is voluntary: the maker finds the problem and pulls the product, or FDA asks it to. FDA's rules call recall "a voluntary action". A mandatory recall is the exception: since the Food Safety Modernization Act, FDA can order a food recalled when there's a reasonable probability the food is adulterated, or missing an allergen from its label, and will cause serious harm or death, but only after offering the company the chance to recall it on its own. Separately, a registered food facility that decides one of its foods is a "reportable food" has 24 hours to report it to FDA. In the example below, a cookie maker's recall runs from a mislabeled bag at 8:15 in the morning to a filed report by mid-afternoon. Below are the three kinds of recall, the 24-hour report, the day, and a free timeline log.

The short version

• Firm-initiated: the maker recalls on its own, at any time, and is asked to tell its FDA district office immediately.
• FDA-requested: FDA asks the firm to recall, in urgent cases where the firm hasn't started one.
• FDA-ordered (mandatory): FDA orders it, if the firm doesn't recall voluntarily and the food is reasonably likely to cause serious harm or death.
• A registered facility reports a reportable food within 24 hours of deciding it is one.
• No report is needed if the problem started with you, never left your hands, and was corrected or destroyed.
• The recall itself, voluntary or not, still means finding every customer who got the lot.
• TaroStack's recall report shows which customers got a lot, and a hold keeps it from shipping. More below.

The three kinds of recall

FDA's rules describe recall as voluntary, an alternative to FDA going to court to seize a product, and reserve FDA's requests for urgent situations. The mandatory order starts the same way, with FDA giving the company the chance to stop distribution and recall; if it refuses or doesn't act, FDA can order it to stop distributing and to tell everyone it sold to, and then, after a chance for a hearing, to recall. This is general information, not legal advice.

The 24-hour reportable food report

A reportable food is one where there's a reasonable probability that using it will cause serious adverse health consequences or death. The responsible party, the company that registered the facility where the food was made or held, has to report it through FDA's electronic portal as soon as practicable and no later than 24 hours after deciding the food is reportable, and investigate the cause if it may have started there (21 U.S.C. 350f). No report is needed if the problem started with the company, was found before the food went to anyone else, and was corrected or destroyed. How facility registration works, and who registers, is in the food facility registration rules; a recall plan written in advance is in recall plan example.

An example: a recall's first day

Granite Peak Cookie Co., a made-up cookie maker in Sandy, Utah, I use in these examples, is a registered facility, since it sells mostly to cafés. On Monday, October 12:

The report was due by 9:00 Tuesday, 24 hours after the decision, and was filed at 15:40 Monday. Had the mislabeled bags been caught on Friday before they shipped and the cookies destroyed, no report would have been needed. The recall itself, who got the lot and what came back, is worked through in the recall classification rules; what the notice to customers says is in how to write a recall letter, and the steps after an allergen slip in undeclared allergen recall.

Get the timeline log

Download the recall timeline log. Two sheets: how recalls start, the three kinds and the reportable food report, each with its rule; and a timeline, each step from the moment a problem is found with the time and who did it, where the 24-hour deadline from the decision and whether the report was in time fill in. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.

Where this stops working

The timeline records what happened. It can't say, at 9:00 on a Monday, which customers got lot GPC-1009-A, how many cookies from it are still on the shelf, or whether anyone else's order is about to pick from it this afternoon. Those three answers decide how the rest of the day goes.

How TaroStack does it

TaroStack's recall report shows which customers got a lot, and a hold keeps it from shipping.

Who got the lot. Each order records the lots each customer got as it ships, so one recall report lists every customer who received GPC-1009-A, how many, and when, with who to call.

A hold in one step. A lot on hold is kept out of what can be sold, so this afternoon's orders can't pick from it, and the same report shows what's still on your own shelves.

Practice before it's real. Timed, logged traceability drills show how fast you can answer "who got this lot", and every list exports to CSV for the report and the notices.

Lots, holds, recalls and traceability drills are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.

Questions people also ask

Are food recalls voluntary?

Almost always. A recall is started by the firm or at FDA's request; FDA can order one only when the firm won't recall a food that's reasonably likely to cause serious harm or death.

Can the FDA force a food recall?

Yes, under its mandatory recall authority, after first giving the company the chance to recall voluntarily.

What is the Reportable Food Registry?

FDA's portal where a registered facility reports, within 24 hours, a food it has decided is reasonably likely to cause serious harm or death.

Do I have to report a recall within 24 hours?

A registered facility reports a reportable food within 24 hours of deciding it is one, unless the problem started with it, never left it, and was corrected or destroyed.