FDA refusal charge ALLERGEN: undeclared allergen
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The ALLERGEN charge appeared in 508 FDA import refusals between 2020 and 2026 — 2.7% of the 19,123 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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What FDA's charge says
ALLERGEN is the code FDA prints on a refusal; below is the charge language FDA publishes for it, quoted from its charge table, with the sections of the FD&C Act it cites.
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
ALLERGEN refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 69 | — | |
| 2021 | 60 | -13.0% | |
| 2022 | 52 | -13.3% | |
| 2023 | 61 | +17.3% | |
| 2024 | 116 | +90.2% | |
| 2025 | 100 | -13.8% | |
| 2026 | 50 | — | YTD |
| Total | 508 |
Origins most often refused under ALLERGEN
| # | Origin country | Refusals |
|---|---|---|
| 1 | India | 103 |
| 2 | China | 66 |
| 3 | South Korea | 61 |
| 4 | Mexico | 17 |
| 5 | Brazil | 16 |
| 6 | Colombia | 16 |
| 7 | Guatemala | 15 |
| 8 | Taiwan | 15 |
| 9 | Canada | 13 |
| 10 | Philippines | 12 |
| 11 | Thailand | 11 |
| 12 | Turkey | 11 |
| 13 | Honduras | 10 |
| 14 | Japan | 10 |
| 15 | Nigeria | 9 |
| 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 | Russia | 4 |
| 27 | Spain | 4 |
| 28 | Germany | 3 |
| 29 | Ghana | 3 |
| 30 | Iraq | 3 |
Product categories refused under ALLERGEN
| # | Product category | Refusals |
|---|---|---|
| 1 | Bakery Products, Doughs, Bakery Mixes, and Icings | 106 |
| 2 | Macaroni and Noodle Products | 83 |
| 3 | Snack Food Items (Flour, Meal, or Vegetable Base) | 60 |
| 4 | Candy Without Chocolate, Candy Specialties, and Chewing Gum | 33 |
| 5 | Fishery/Seafood Products | 28 |
| 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 | 12 |
| 11 | Chocolate and Cocoa Products | 12 |
| 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 |
Latest refusals citing ALLERGEN
- 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
- 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
- SCS-8525965-0 CHOCOLATE COVERED CANDY BAR, WITHOUT NUTS AND FRUITFrom United Kingdom, Chocolate and Cocoa Products. no net quantityundeclared allergennutrition labeling
- BNI-0146958-2 TAPIOCA STARCH PRODUCTFrom Ghana, Whole Grains, Milled Grain Products, and Starch. not to standard of identityundeclared allergennutrition labelinglabeling
- 065-0914763-0 OTHER BAKERY PRODUCTS, N.E.C.From China, Bakery Products, Doughs, Bakery Mixes, and Icings. unsafe color additivecolor not declaredno manufacturer nameno net quantity+2 more
- 1FX-6651417-5 MAGNESIUM (MINERAL)From Lithuania, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listedsupplement labelingundeclared allergennutrition labeling
About ALLERGEN
What does the FDA import refusal charge ALLERGEN mean?
FDA uses ALLERGEN for: undeclared allergen. Its published charge language reads: “the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).”
Is ALLERGEN a food safety finding?
Yes. This site counts ALLERGEN as a hazard finding, so a refusal citing it is on the hazard side of the hazard and paperwork split, whatever else the refusal cites.
What happens to a shipment refused under ALLERGEN?
Under section 801(a) of the FD&C Act a refused entry has to be exported or destroyed, normally within 90 days of the notice of refusal. Bringing a product into compliance, for instance by relabelling, is something the importer asks FDA for before the decision is final. The notice itself and FDA's guidance govern a particular case; this page describes the published data and is not legal advice.