Last refresh: · 25,892 refusals since 2020-01-01

Undeclared allergens in US Food Imports — FDA Import Refusals

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Undeclared allergens appeared in 511 FDA import refusals between 2020 and 2026 — 2.0% of the 25,860 refusals that identify a hazard. The origins cited most often are India, China, South Korea. The most-affected product category is Bakery Products, Doughs, Bakery Mixes, and Icings. Volume in 2025 was down 14% on 2024.

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Undeclared allergens notifications by year

YearNotificationsof which border rejectionsYoY
2020 70 70 —
2021 61 61 -12.9%
2022 53 53 -13.1%
2023 64 64 +20.8%
2024 117 117 +82.8%
2025 101 101 -13.7%
2026 45 45 — YTD
Total511

Origins most cited for Undeclared allergens

#Origin countryNotifications
1 India 104
2 China 67
3 South Korea 62
4 Taiwan 17
5 Brazil 16
6 Colombia 16
7 Mexico 16
8 Guatemala 15
9 Canada 13
10 Philippines 12
11 Thailand 11
12 Turkey 11
13 Japan 10
14 Nigeria 9
15 United Kingdom 9
16 Honduras 8
17 Jordan 7
18 Vietnam 7
19 Jamaica 6
20 Bangladesh 5
21 Dominican Republic 5
22 Pakistan 5
23 Israel 4
24 Italy 4
25 Lebanon 4
26 Myanmar 4
27 Russia 4
28 Spain 4
29 Germany 3
30 Ghana 3

Product categories where Undeclared allergens appears

#Product categoryNotifications
1Bakery Products, Doughs, Bakery Mixes, and Icings107
2Macaroni and Noodle Products84
3Snack Food Items (Flour, Meal, or Vegetable Base)60
4Candy Without Chocolate, Candy Specialties, and Chewing Gum30
5Fishery/Seafood Products29
6Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans24
7Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet)20
8Soft Drinks and Waters17
9Milk, Butter, and Dried Milk Products14
10Cereal Preparations, Breakfast Foods13
11Chocolate and Cocoa Products13
12Dietary Conventional Foods and Meal Replacements11
13Nuts and Edible Seeds11
14Fruit and Fruit Products9
15Vegetables and Vegetable Products9

Recent Undeclared allergens notifications

About Undeclared allergens

Allergen charges cover food whose label fails to declare a major food allergen as Section 403(w) requires, and the related charge for allergen residue introduced through insanitary cross-contact under Section 402(a)(4) — undeclared milk, egg, peanut, tree nut, soy, wheat, fish, shellfish and the other named allergens. Though rooted in a labelling failure, it is grouped as a hazard here because an undeclared allergen is a direct safety risk to a sensitised consumer, not an administrative omission. Refusals concentrate in bakery, confectionery and sauces with complex ingredient lists.

Which FDA import refusals does this page count?

Every entry FDA refused that cites this hazard among its charge codes. A single entry can carry more than one charge, so an entry refused for both a pathogen and a labelling defect is counted on both the relevant hazard page and, separately, in the hazard/paperwork split shown on the leaderboard.

What happens when this hazard is found in a shipment?

The entry is refused admission into US commerce. The importer must recondition the shipment (where that is possible), export it out of the United States, or have it destroyed under FDA supervision. Repeated findings against one shipper or product can lead FDA to place them on an Import Alert, which subjects future shipments to detention without physical examination.

Where does this data come from?

The public FDA Import Refusal Report, refetched weekly. Counts are per entry (consignment), so one entry listing several charge codes for the same hazard is counted once.