An undeclared allergen recall happens when a food contains one of the major food allergens, milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans or sesame, and the label doesn't say so. Because a person with that allergy can't protect themselves from what the label doesn't show, an undeclared allergen can fit FDA's most serious recall class. The usual causes are ordinary: the right product in the wrong bag, a recipe changed without changing the label, a supplier's ingredient that now contains milk. The steps are the same every time: stop and hold, find every unit by lot, tell your customers and the regulator, warn the public if you can't reach every buyer, fix the cause, and keep the record. Below is each step, a worked example, and how to keep it from happening.
The short version
- Nine major allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame.
- Each must be declared, in the ingredient list or a "Contains" statement.
- The usual causes are wrong labels, recipe changes and supplier changes.
- Stop and hold first; then trace every unit by lot.
- Tell customers, the regulator, and the public if needed; registered facilities may have 24 hours to report.
- Fix the cause, check every customer acted, and keep the record.
- TaroStack finds every unit of a lot, and who has it, in one report. More below.
The allergens and the label
FDA lists nine major food allergens; sesame became the ninth on January 1, 2023. Each must be declared, either in parentheses after the ingredient, like "flour (wheat)" or "whey (milk)", or in a "Contains" statement right after the ingredient list, like "Contains wheat, milk, and soy" (FDA, food allergies). A label that leaves one out, or names it only in a way a reader wouldn't recognize, has an undeclared allergen.
The usual causes
| Cause | Example |
|---|---|
| The wrong label or bag | Macadamia shortbread packed in plain shortbread bags |
| A recipe change, old labels | Butter added to a vegan cookie; the labels still say no milk |
| A supplier's change | New chocolate chips that contain milk |
| An ingredient named without its allergen | "Flour" without "(wheat)"; "lecithin" without "(soy)" |
| Cross-contact | Sesame from one product on shared equipment in the next |
An allergen matrix, every product against every allergen, makes the label check a matter of reading across a row, and a template is in allergen matrix template.
The steps
| Step | What to do | When |
|---|---|---|
| 1. Stop and hold | Stop selling and shipping the lot; hold what's on hand | The hour you find out |
| 2. Trace | Every unit of the lot: on hand, at each customer, sold direct | Same day |
| 3. Tell your customers | Call every store and distributor; follow with a letter | Same day |
| 4. Tell the regulator | FDA's recall coordinator, or your state; a registered facility may owe a Reportable Food Registry report within 24 hours | Same day |
| 5. Warn the public | If you sold direct and can't reach every buyer: a notice where they'll see it | As agreed with the regulator |
| 6. Fix the cause | Labels, recipe, supplier check, cleaning | Before the next batch |
| 7. Check it worked | Each customer confirms what they pulled; count what came back | Within days |
| 8. Close it out | Records of every step; agree the end with the regulator | When it's done |
FDA classifies recalls by hazard; Class I is a situation where there's a reasonable probability that the product will cause serious adverse health consequences or death (21 CFR 7.3), and an undeclared major allergen can fit it. A registered food facility that finds a food is a reportable food, one with a reasonable probability of serious harm, reports it to FDA's Reportable Food Registry within 24 hours (21 U.S.C. 350f). What to write to customers is in how to write a recall letter. This is general information, not legal advice; talk to your regulator as soon as you know.
A worked example
Windward Roots, the made-up taro business I use in these examples, packs taro shortbread and macadamia shortbread on the same morning. A market customer mentions there were nuts in their "taro shortbread." The bag's lot code is MS-261008: it's the macadamia shortbread, in plain taro shortbread bags, which don't declare tree nuts.
| Where lot MS-261008 is | Bags |
|---|---|
| On hand at the kitchen | 36 |
| Corner Market | 24 |
| Harbor Gallery | 12 |
| A café | 12 |
| Sold at Saturday's market | 12 |
| Made | 96 |
The 36 on hand are held within the hour. The three shops are called by noon and pull 48 bags. The 12 sold at the market went to people Windward Roots can't name, so with the regulator's agreement a notice goes up at the market and on its pages. The cause: both products' bags were on the packing table at once. The fix: one product's bags on the table at a time, and a label check with a signature on every batch. A recall plan that sets this out in advance is in recall plan example.
Where this stops working
With paper records, step 2 is the slow one. Which lot was it? Which batch, which bags, which shops, and did any go to the café that orders by text? The packing list is in a binder, the deliveries are in an invoice folder, and the market sales aren't anywhere. Every hour spent searching is an hour the bags stay on a shelf.
How TaroStack does it
TaroStack makes step 2 a single report, and puts a label check on every batch.
Every unit of a lot, in one report. Give TaroStack the lot code and one report shows what's still on your own shelves at every site, every customer who received it, with their contact details, and the batch and ingredient lots behind it. Stock on hold sits apart from what's available, so the held lot can't be shipped while you work, and customer returns go back into the lot they left in, so what comes back is counted against it.
The label check, recorded. Batch record forms are filled in as the batch is recorded, with your own fields, like "labels checked against the product" and a sign-off. Recipes have versions, so adding butter to the vegan cookie is a new version on every batch that follows: the cue to change the label. If a supplier's ingredient is the cause, the same report walks back to that supplier lot and every other batch that used it.
And you can practise. Timed, logged traceability drills run the whole trace on a lot you choose, and keep a record of how long it took, to show a buyer or an inspector.
| The step | Binders and folders | In TaroStack |
|---|---|---|
| What's on hand | Walk the shelves | Stock by site, by lot |
| Which customers got it | Search the invoices | One report, with contacts |
| Keep it from shipping | A note on the shelf | On hold, apart from available stock |
| Was the label checked? | Nobody wrote it down | A batch record field with sign-off |
Lots, holds, recalls, traceability drills, recipes with versions and batch records 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.