Undeclared allergens in US Food Imports — FDA Import Refusals
Undeclared allergens appeared in 520 FDA import refusals between 2020 and 2026 — 2.7% of the 19,236 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 refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 70 | — | |
| 2021 | 61 | -12.9% | |
| 2022 | 53 | -13.1% | |
| 2023 | 64 | +20.8% | |
| 2024 | 117 | +82.8% | |
| 2025 | 101 | -13.7% | |
| 2026 | 54 | — | YTD |
| Total | 520 |
Origins most cited for Undeclared allergens
| # | Origin country | Refusals |
|---|---|---|
| 1 | India | 104 |
| 2 | China | 67 |
| 3 | South Korea | 62 |
| 4 | Guatemala | 18 |
| 5 | Mexico | 17 |
| 6 | Taiwan | 17 |
| 7 | Brazil | 16 |
| 8 | Colombia | 16 |
| 9 | Canada | 13 |
| 10 | Philippines | 12 |
| 11 | Japan | 11 |
| 12 | Thailand | 11 |
| 13 | Turkey | 11 |
| 14 | Honduras | 10 |
| 15 | Nigeria | 10 |
| 16 | United Kingdom | 9 |
| 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 category | Refusals |
|---|---|---|
| 1 | Bakery Products, Doughs, Bakery Mixes, and Icings | 108 |
| 2 | Macaroni and Noodle Products | 84 |
| 3 | Snack Food Items (Flour, Meal, or Vegetable Base) | 61 |
| 4 | Candy Without Chocolate, Candy Specialties, and Chewing Gum | 34 |
| 5 | Fishery/Seafood Products | 31 |
| 6 | Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans | 24 |
| 7 | Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet) | 20 |
| 8 | Soft Drinks and Waters | 18 |
| 9 | Milk, Butter, and Dried Milk Products | 14 |
| 10 | Cereal Preparations, Breakfast Foods | 13 |
| 11 | Chocolate and Cocoa Products | 13 |
| 12 | Dietary Conventional Foods and Meal Replacements | 11 |
| 13 | Nuts and Edible Seeds | 11 |
| 14 | Fruit and Fruit Products | 9 |
| 15 | Vegetables and Vegetable Products | 9 |
FDA charge codes in Undeclared allergens
| Code | What it means | Refusals |
|---|---|---|
ALLERGEN | undeclared allergen | 512 |
Recent Undeclared allergens refusals
- 235-1768372-0 SNAILS, AQUATIC, OTHER AQUATIC SPECIESFrom Japan, Fishery/Seafood Products. ingredients not listedundeclared allergenno process filing
- U72-0540939-5 FISH, N.E.C.From Nigeria, Fishery/Seafood Products. filthfalse or misleading labelundeclared allergenlabeling+1 more
- 1FX-6266038-7 MINT CANDY, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)From Guatemala, Candy Without Chocolate, Candy Specialties, and Chewing Gum. no manufacturer nameno net quantitynot in Englishundeclared allergen+1 more
- 9L9-0254322-7 CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)From Mexico, Candy Without Chocolate, Candy Specialties, and Chewing Gum. undeclared allergenlabelingnutrition labeling
- 1FX-5690254-8 LOLLIPOP (WITHOUT CHOCOLATE)From Honduras, Candy Without Chocolate, Candy Specialties, and Chewing Gum. no manufacturer namerxlabellabelingnutrition labeling+1 more
- 1FX-5191937-2 JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)From Sweden, Candy Without Chocolate, Candy Specialties, and Chewing Gum. ingredients not listedlabel not conspicuouscolor not declaredno manufacturer name+6 more
- 826-0255089-7 SOFT DRINK, CITRUS FRUIT FLAVORED, NONCARBONATEDFrom Guatemala, Soft Drinks and Waters. unsafe color additiveingredients not listednot to standard of identitynot in English+3 more
- ASE-1514928-9 MIXED PLAIN COOKIES,BISCUITS AND WAFERSFrom Honduras, Bakery Products, Doughs, Bakery Mixes, and Icings. undeclared allergennutrition labelingunsafe color additivecolor not declared
- 8Q4-0009450-9 CORN CHIPS, FRIEDFrom Guatemala, Snack Food Items (Flour, Meal, or Vegetable Base). unsafe color additivenot to standard of identityno net quantitynot in English+5 more
- EJ2-0204154-0 FLAVORED OR PARTY CRACKERSFrom China, Bakery Products, Doughs, Bakery Mixes, and Icings. ingredients not listedundeclared allergennutrition labeling
- EJR-1044697-3 PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.From Honduras, Bakery Products, Doughs, Bakery Mixes, and Icings. filthundeclared allergen
- EVY-0059419-8 ICE CREAM, REGULAR, NOT VANILLA OR VANILLIN FLAVOREDFrom China, Ice Cream and Related Products. unsafe color additiveno net quantityno common nameingredients not listed+2 more
- 8QB-0001357-6 CHEESE PRODUCTS, STANDARDIZED, N.E.C.From Honduras, Cheese and Cheese Products. ingredients not listedno manufacturer nameno net quantityno common name+3 more
- CFQ-8133188-2 CORN CHIPS, FRIEDFrom Guatemala, Snack Food Items (Flour, Meal, or Vegetable Base). ingredients not listedlabel not conspicuousundeclared allergennutrition labeling
- KM6-3673065-7 NOODLES AND NOODLE PRODUCTS, N.E.C.From India, Macaroni and Noodle Products. ingredients not listedcolor not declaredno manufacturer nameno net quantity+5 more
- AEK-0418776-0 ACACIA RIGIDULA (HERBAL AND BOTANICALS, NOT TEAS II)From India, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. label not conspicuousundeclared allergenlabelingnutrition labeling
- U72-0540487-5 NUTS, IN SHELL, N.E.C.From Nigeria, Nuts and Edible Seeds. no net quantitynutrition labelingingredients not listedno manufacturer name+3 more
- 551-4163463-1 BAKLAVAFrom Canada, Bakery Products, Doughs, Bakery Mixes, and Icings. unsafe color additivecolor not declaredundeclared allergennutrition labeling
- KM6-3678694-9 OTHER BAKERY PRODUCTS, N.E.C.From India, Bakery Products, Doughs, Bakery Mixes, and Icings. filthunsafe color additiveingredients not listedno net quantity+4 more
- 8B4-0012422-6 SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)From Senegal, Fishery/Seafood Products. ingredients not listedno net quantitynot in Englishno common name+3 more
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.