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FDA import refusals

FDA import refusals from Ecuador

Food, dietary supplements and animal food · October 2016 to September 8, 2026 · how the data is collected

FDA refused 542 shipment lines from Ecuador between October 2016 and September 2026, including 65 in 2026 through September 8, 2026; the most common charges were FILTHY, PESTICIDE and NO ENGLISH, and the most refused category was seafood.

Data from FDA public records, last checked .

542
refused shipment lines since October 2016
65
refused so far in 2026
412
Ecuador firms with an FDA record
180
firms on an active import alert

Refusals from Ecuador by year

Shipment lines FDA refused each year. The table has the same numbers as the chart.
Bar chart: refusal lines by 2016 to 2026. The same numbers are in the table.0204060802016 (from October 1): 25 refusal lines’162017: 65 refusal lines’172018: 49 refusal lines’182019: 33 refusal lines’192020: 36 refusal lines’202021: 30 refusal lines’212022: 52 refusal lines’222023: 51 refusal lines’232024: 72 refusal lines72’242025: 64 refusal lines’252026 (year to date): 65 refusal lines65’26*
* 2026 is year to date, through September 8, 2026. FDA's refusal data starts on October 1, 2016, so 2016 covers three months.
Refusal lines by year
YearRefusal linesvs prior year
2026 (to date)65
202564-11%
202472+41%
202351-2%
202252+73%
202130-17%
202036+9%
201933-33%
201849-25%
201765
2016 (from Oct)25

Why FDA refused Ecuador shipment lines

FDA records a charge code on each refused line; one line can carry several. Each code opens FDA's official statement and the countries and products behind it.
Most frequent refusal charges for Ecuador
Charge codeMeaningLinesShare
FILTHYFilthy, putrid or decomposed substance20535%
PESTICIDEPesticide chemical residue8314%
NO ENGLISHRequired label information not in English6411%
SALMONELLASalmonella5910%
NUTRIT LBLNutrition information missing from label427%
HISTAMINEHistamine315%
LABELINGFair Packaging and Labeling Act264%
LACKS FIRMManufacturer name and address missing254%
LIST INGREIngredients not listed254%
UNAPPROVEDUnapproved new drug254%

What FDA refused from Ecuador, by product category

FDA product categories, most refused first. Open a category for its product, charge and firm tables.
FDA import refusals from Ecuador by product category
CategoryMost refused productsLines
SeafoodFishery/Seafood ProductsMahi mahi; Shrimp and prawns, aquaculture harvested fishery/seafood products; Swordfish284
Root vegetables and mushroomsVegetables and Vegetable Products (root and tuber vegetables, fungi)Taro, dasheen (root & tuber vegetable); Cassava, breaded; Potato (root & tuber vegetable)76
Dietary supplementsVitamins, Minerals, Proteins, and Unconventional Dietary SpecialtiesVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.; Herbals & botanicals (not teas), n.e.c.; Herbals & botanical teas, n.e.c.27
Tropical and pit fruitFruit and Fruit Products (pit, subtropical and tropical fruits)Tamarind (subtropical/tropical fruit pulp); Dragon fruit, subtropical and tropical fruit; Mango (subtropical and tropical fruit)23
Soft drinks and waterSoft Drinks and WatersSoft drink, milk based (chocolate flavored, etc.), noncarbonated; Mineral water, carbonated water (nonmedicinal); Carbonated soft drink, n.e.c.17
Bakery productsBakery Products, Doughs, Bakery Mixes, and IcingsChocolate plain cookies,biscuits and wafers; Cake,custard or cream filled; Cake without custard or cream filling15
Vegetables (legumes and leafy)Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables)Tomatoes (fruit used as vegetable); Pepper, hot, n.e.c. (fruit used as vegetable); Pigeon peas12
CheeseCheese and Cheese ProductsCheese products, non-standardized, n.e.c.; Cheese, hispanic/latino/mexican style, all varieties, including queso; Cheese, hard (chesire,esrum,fortina,fortine,kasseni,mozzarella,montasio,pecarino,port salut, etc)10
Grains and starchWhole Grains, Milled Grain Products, and StarchOats, whole grain; Tapioca starch product; Wheat flour, n.e.c.9
SpicesSpices, Flavors, and SaltsMixed spice and seasonings, ground, cracked, without salt, n.e.c.; Basil (sweet basil), whole (spice)9
Snack foodsSnack Food ItemsBaked snack food, n.e.c.; Corn chips, fried; Fried snack foods, n.e.c.8
Meat and poultryMeat, Meat Products, and PoultryGuinea pig8
Berries and citrusFruit and Fruit Products (berries, citrus and core fruits)Apple (core fruit purees); Blackberries (berry)8
Coffee and teaCoffee and TeaNovelty teas, n.e.c.; Tea, black8
Milk and butterMilk, Butter, and Dried Milk ProductsMilk with multivitamins added,low fat; Yogurt (plain, flavored or fruit added)6
Candy and chewing gumCandy without Chocolate, Candy Specialties, and Chewing GumMixed/assorted hard candy without nuts and fruit (without chocolate); Soft candy with fruit, n.e.c. (without chocolate)4
Cereals and breakfast foodsCereal Preparations, Breakfast FoodsOat flakes, rolled oats,puffs,krispies,loops ready to eat; Oatmeal, regular, fruit or spice added, quick or instant cooking3
Imitation milkFilled Milk and Imitation Milk ProductsFilled or imitation milk or milk type products not elsewhere mentioned, n.e.c.3
Chocolate and cocoaChocolate and Cocoa ProductsChocolate and chocolate covered candy, without nuts and fruit, n.e.c.; Chocolate and cocoa products, n.e.c.; Chocolate and cocoa, n.e.c.3
Sauces and prepared mealsMultiple Food Dinners, Gravies, Sauces, and SpecialtiesGarlic sauce; Sauces, n.e.c.; Soy sauce3
Noodles and pastaMacaroni and Noodle ProductsNoodles, enriched1
Beverage basesBeverage BasesBeverage base, berry1
Gelatin and puddingsGelatin, Rennet, Pudding Mixes, and Pie FillingsPudding (pie filling) mix, n.e.c. (not custard)1
SoupsSoupsChicken noodle soup, dried1
Meal replacementsDietary Conventional Foods and Meal ReplacementsDietary conventional foods, n.e.c.1
Animal feedNon-Medicated Animal FeedsAnimal feeds, n.e.c.1

Most refused products from Ecuador

FDA's product descriptions on the refused lines, grouped case-insensitively.
Most refused products from Ecuador
ProductLinesShare
Mahi mahi11220.7%
Taro, dasheen (root & tuber vegetable)7012.9%
Shrimp and prawns, aquaculture harvested fishery/seafood products6011.1%
Swordfish275.0%
Fish maw, fishery products, n.e.c.203.7%
Shrimp & prawns193.5%
Tuna (albacore, yellowfin, bluefin, skipjack, etc.)152.8%
Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.142.6%
Tamarind (subtropical/tropical fruit pulp)122.2%
Sardines (brisling, sprats, pilchards, etc.)112.0%

FDA import alerts that list Ecuador firms

21 alerts list at least one firm in Ecuador: 114 firms on a red list, 180 firms on any list.
Import alerts listing firms in Ecuador
AlertCoversRedGreen
16-05Mahimahi from Ecuador and Taiwan: histamine, decomposition76
99-05Raw agricultural products: pesticides46
16-81Seafood products: Salmonella14
16-105Fish products: decomposition, histamine or indole10
16-125Refrigerated raw fish in reduced oxygen packaging9
16-120Seafood from processors not in compliance with HACCP8
99-19Food products: Salmonella6
99-38Low-acid canned/acidified foods: inadequate process control6
99-08Processed human and animal foods: pesticides5
45-02Foods with illegal or undeclared colors4
99-37Low-acid canned/acidified foods without scheduled process3
99-39Imported foods that appear to be misbranded3

The 12 alerts with the most listings. All alerts are on the import alerts page.

Ecuador firms with the most FDA records

Counts are FDA records in SupplierRadar's data (refusals, import alert listings and other events), not a ranking of quality.

Latest refusals from Ecuador

The 20 most recent refused lines, each with its FDA source.
Latest FDA import refusals from Ecuador
DateFirmProductCharges
Carvagu S SGuayaquil, EcuadorVitamin c (ascorbic acid)UNAPPROVEDSource
Gambas del PacificoGuayaquil, EcuadorShrimp & prawnsFILTHYSource
Expotuna S.A.Guayaquil, EcuadorShrimp & prawnsSALMONELLASource
Expotuna S.A.Guayaquil, EcuadorShrimp & prawnsSALMONELLASource
Expotuna S.A.Guayaquil, EcuadorShrimp & prawnsSALMONELLASource
Expotuna S.A.Guayaquil, EcuadorShrimp & prawnsSALMONELLASource
Expotuna S.A.Guayaquil, EcuadorShrimp & prawnsSALMONELLASource
Expotuna S.A.Guayaquil, EcuadorShrimp & prawnsSALMONELLASource
Expotuna S.A.Guayaquil, EcuadorShrimp & prawnsSALMONELLASource
Expotuna S.A.Guayaquil, EcuadorShrimp & prawnsSALMONELLASource
Lambac S.A.Guayas, EcuadorHerbals & botanicals (not teas), n.e.cLABELINGNUTRIT LBLHEALTH CSource
Laboratorios LabmacDuran, EcuadorVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNO ENGLISHUNAPPROVEDSource
Lambac S.A.Guayas, EcuadorHerbals & botanicals (not teas), n.e.cHEALTH CSource
Laboratorios LabmacDuran, EcuadorVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNO ENGLISHUNAPPROVEDSource
Laboratorios LabmacDuran, EcuadorVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNO ENGLISHUNAPPROVEDSource
Laboratorios LabmacDuran, EcuadorVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNO ENGLISHUNAPPROVEDSource
Munoz Pin Anderson RobertoGuayaquil, EcuadorVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cUNAPPROVEDSource
Munoz Pin Anderson RobertoGuayaquil, EcuadorVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cUNAPPROVEDSource
Munoz Pin Anderson RobertoGuayaquil, EcuadorVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cUNAPPROVEDSource
Munoz Pin Anderson RobertoGuayaquil, EcuadorVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cUNAPPROVEDSource

Questions about FDA refusals from Ecuador

How many Ecuador shipments did FDA refuse in 2026?
FDA refused 65 shipment lines from Ecuador in 2026 through September 8, 2026, compared with 64 in 2025 (a full year).
Why does FDA refuse food from Ecuador?
FDA records a charge code on every refused shipment line. For Ecuador the most frequent are FILTHY (filthy, putrid or decomposed substance, 205 lines), PESTICIDE (pesticide chemical residue, 83 lines) and NO ENGLISH (required label information not in English, 64 lines). A charge describes what FDA's reference table says about one shipment line; it is not a finding about every firm in the country.
Which Ecuador firms have the most FDA refusals?
In SupplierRadar's records the Ecuador firms with the most FDA records (refusals, import alert listings and other events) are GRUPO DEGFER CIA LTDA (Manta) with 32 records, Propemar S.A. (Montecristi) with 25 records and EXPOTUNA S.A. (Guayaquil) with 23 records. Each firm's page lists every record with its FDA source.
Which FDA import alerts list Ecuador firms?
As of October 26, 2026, 21 FDA import alerts list at least one firm in Ecuador. The alerts with the most Ecuador listings are Import Alert 16-05 (76 firms), Import Alert 99-05 (46 firms) and Import Alert 16-81 (14 firms).
How many Ecuador firms are on an FDA import alert red list?
As of October 26, 2026, 114 Ecuador firms are on the red list of at least one FDA import alert in SupplierRadar's records, and 180 firms are on any list.

All Ecuador suppliers with FDA records (195)

Every Ecuador firm in SupplierRadar's data with an active import alert, a warning letter or at least five FDA records, most recently active first. Each name opens the firm's FDA record history.

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.