FDA import refusals
FDA import refusals from Ecuador
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
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 65 | |
| 2025 | 64 | -11% |
| 2024 | 72 | +41% |
| 2023 | 51 | -2% |
| 2022 | 52 | +73% |
| 2021 | 30 | -17% |
| 2020 | 36 | +9% |
| 2019 | 33 | -33% |
| 2018 | 49 | -25% |
| 2017 | 65 | |
| 2016 (from Oct) | 25 |
Why FDA refused Ecuador shipment lines
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| FILTHY | Filthy, putrid or decomposed substance | 205 | 35% |
| PESTICIDE | Pesticide chemical residue | 83 | 14% |
| NO ENGLISH | Required label information not in English | 64 | 11% |
| SALMONELLA | Salmonella | 59 | 10% |
| NUTRIT LBL | Nutrition information missing from label | 42 | 7% |
| HISTAMINE | Histamine | 31 | 5% |
| LABELING | Fair Packaging and Labeling Act | 26 | 4% |
| LACKS FIRM | Manufacturer name and address missing | 25 | 4% |
| LIST INGRE | Ingredients not listed | 25 | 4% |
| UNAPPROVED | Unapproved new drug | 25 | 4% |
What FDA refused from Ecuador, by product category
| Category | Most refused products | Lines |
|---|---|---|
| SeafoodFishery/Seafood Products | Mahi mahi; Shrimp and prawns, aquaculture harvested fishery/seafood products; Swordfish | 284 |
| 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 Specialties | Vitamin, 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 Waters | Soft 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 Icings | Chocolate plain cookies,biscuits and wafers; Cake,custard or cream filled; Cake without custard or cream filling | 15 |
| 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 peas | 12 |
| CheeseCheese and Cheese Products | Cheese 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 Starch | Oats, whole grain; Tapioca starch product; Wheat flour, n.e.c. | 9 |
| SpicesSpices, Flavors, and Salts | Mixed spice and seasonings, ground, cracked, without salt, n.e.c.; Basil (sweet basil), whole (spice) | 9 |
| Snack foodsSnack Food Items | Baked snack food, n.e.c.; Corn chips, fried; Fried snack foods, n.e.c. | 8 |
| Meat and poultryMeat, Meat Products, and Poultry | Guinea pig | 8 |
| Berries and citrusFruit and Fruit Products (berries, citrus and core fruits) | Apple (core fruit purees); Blackberries (berry) | 8 |
| Coffee and teaCoffee and Tea | Novelty teas, n.e.c.; Tea, black | 8 |
| Milk and butterMilk, Butter, and Dried Milk Products | Milk with multivitamins added,low fat; Yogurt (plain, flavored or fruit added) | 6 |
| Candy and chewing gumCandy without Chocolate, Candy Specialties, and Chewing Gum | Mixed/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 Foods | Oat flakes, rolled oats,puffs,krispies,loops ready to eat; Oatmeal, regular, fruit or spice added, quick or instant cooking | 3 |
| Imitation milkFilled Milk and Imitation Milk Products | Filled or imitation milk or milk type products not elsewhere mentioned, n.e.c. | 3 |
| Chocolate and cocoaChocolate and Cocoa Products | Chocolate 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 Specialties | Garlic sauce; Sauces, n.e.c.; Soy sauce | 3 |
| Noodles and pastaMacaroni and Noodle Products | Noodles, enriched | 1 |
| Beverage basesBeverage Bases | Beverage base, berry | 1 |
| Gelatin and puddingsGelatin, Rennet, Pudding Mixes, and Pie Fillings | Pudding (pie filling) mix, n.e.c. (not custard) | 1 |
| SoupsSoups | Chicken noodle soup, dried | 1 |
| Meal replacementsDietary Conventional Foods and Meal Replacements | Dietary conventional foods, n.e.c. | 1 |
| Animal feedNon-Medicated Animal Feeds | Animal feeds, n.e.c. | 1 |
Most refused products from Ecuador
| Product | Lines | Share |
|---|---|---|
| Mahi mahi | 112 | 20.7% |
| Taro, dasheen (root & tuber vegetable) | 70 | 12.9% |
| Shrimp and prawns, aquaculture harvested fishery/seafood products | 60 | 11.1% |
| Swordfish | 27 | 5.0% |
| Fish maw, fishery products, n.e.c. | 20 | 3.7% |
| Shrimp & prawns | 19 | 3.5% |
| Tuna (albacore, yellowfin, bluefin, skipjack, etc.) | 15 | 2.8% |
| Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. | 14 | 2.6% |
| Tamarind (subtropical/tropical fruit pulp) | 12 | 2.2% |
| Sardines (brisling, sprats, pilchards, etc.) | 11 | 2.0% |
FDA import alerts that list Ecuador firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 16-05 | Mahimahi from Ecuador and Taiwan: histamine, decomposition | 76 | |
| 99-05 | Raw agricultural products: pesticides | 46 | |
| 16-81 | Seafood products: Salmonella | 14 | |
| 16-105 | Fish products: decomposition, histamine or indole | 10 | |
| 16-125 | Refrigerated raw fish in reduced oxygen packaging | 9 | |
| 16-120 | Seafood from processors not in compliance with HACCP | 8 | |
| 99-19 | Food products: Salmonella | 6 | |
| 99-38 | Low-acid canned/acidified foods: inadequate process control | 6 | |
| 99-08 | Processed human and animal foods: pesticides | 5 | |
| 45-02 | Foods with illegal or undeclared colors | 4 | |
| 99-37 | Low-acid canned/acidified foods without scheduled process | 3 | |
| 99-39 | Imported foods that appear to be misbranded | 3 |
The 12 alerts with the most listings. All alerts are on the import alerts page.
Ecuador firms with the most FDA records
| Firm | City | FDA records |
|---|---|---|
| Grupo Degfer Cia Ltda | Manta | 32 |
| Propemar S.A. | Montecristi | 25 |
| Expotuna S.A. | Guayaquil | 23 |
| Agricola Palmeiras Agripal S.A | Guayaquil | 18 |
| Reypezpacific S.A. | Esmeraldas | 15 |
| Vasquez Lopez Edgar Vinicio | Ambato | 14 |
| Industrial Pesquera Santa Priscila S.A. | Guayaquil | 13 |
| Compania Productora Y Exportadora Panaglobal CIA LTDA | Quito | 13 |
| Transcity S.A. | Guayaquil | 12 |
| Empacadora Coral del Pacifico EMCOPAC S.A. | Esmeraldas | 11 |
Latest refusals from Ecuador
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Carvagu S SGuayaquil, Ecuador | Vitamin c (ascorbic acid) | UNAPPROVED | Source | |
| Gambas del PacificoGuayaquil, Ecuador | Shrimp & prawns | FILTHY | Source | |
| Expotuna S.A.Guayaquil, Ecuador | Shrimp & prawns | SALMONELLA | Source | |
| Expotuna S.A.Guayaquil, Ecuador | Shrimp & prawns | SALMONELLA | Source | |
| Expotuna S.A.Guayaquil, Ecuador | Shrimp & prawns | SALMONELLA | Source | |
| Expotuna S.A.Guayaquil, Ecuador | Shrimp & prawns | SALMONELLA | Source | |
| Expotuna S.A.Guayaquil, Ecuador | Shrimp & prawns | SALMONELLA | Source | |
| Expotuna S.A.Guayaquil, Ecuador | Shrimp & prawns | SALMONELLA | Source | |
| Expotuna S.A.Guayaquil, Ecuador | Shrimp & prawns | SALMONELLA | Source | |
| Expotuna S.A.Guayaquil, Ecuador | Shrimp & prawns | SALMONELLA | Source | |
| Lambac S.A.Guayas, Ecuador | Herbals & botanicals (not teas), n.e.c | LABELINGNUTRIT LBLHEALTH C | Source | |
| Laboratorios LabmacDuran, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Lambac S.A.Guayas, Ecuador | Herbals & botanicals (not teas), n.e.c | HEALTH C | Source | |
| Laboratorios LabmacDuran, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Laboratorios LabmacDuran, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Laboratorios LabmacDuran, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Munoz Pin Anderson RobertoGuayaquil, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Munoz Pin Anderson RobertoGuayaquil, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Munoz Pin Anderson RobertoGuayaquil, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Munoz Pin Anderson RobertoGuayaquil, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
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)
- Expotuna S.A.Guayaquil
- Industrial Pesquera Santa Priscila S.A. (Factory 2)Guayaquil
- Rameshi Snack S.A.S.Portoviejo
- Jimbofoods S.A.S.Mocha
- Verionica Lucia Vasquez LopezAmbato
- Vasquez Lopez Edgar VinicioAmbato
- Pacetol S.AGuayaquil
- Compania Agricola Ganadera S.A. ChongonGuayaquil
- Compania Agricola Ganadera S.A. Hacienda El ChaparralBalzar
- Sociedad Nacional de Galapagos C.A.Guayaquil
- SagacomexQuito
- EcuarurukunaGuayaquil
- Industrias Lacteas Toni S.A.Guayaquil
- Lubia AMerica Perez SantosGuayaquil
- Fabian Ernesto Villaruel SanchezEl Carmen
- Compania Productora Y Exportadora Panaglobal CIA LTDAQuito
- Empacadora Coral del Pacifico EMCOPAC S.A.Esmeraldas
- Profrutas Cia, LtdaGuayaquil
- Austrofood S.A.S.Quito
- Fresh Fish del Ecuador Cia., Ltda.Manta
- Cancio Canga Jimena AlexandraGuayaquil
- Pablo Francisco Beltran SanchezQuito
- Ecuadorian Food IndustriesGuayaquil
- Frio y Mariscos Cia. Ltda. FrimarGuayaquil
- Negocios Industriales Real S-.A (Nirsa)Guayaquil
- Empacadora Bilbo S.A.Montecristi
- Asesora Asesores Integrales Delagro Asinagro SASDaule
- Sanchez Obando Alexander RicardoQuito
- Chang Sheng SASGuayaquil
- Propemar S.A.Montecristi
- ServilordGuayaquil
- Gondi S.A.Portoviejo
- Tierra LindaAmbato
- Family Food Ecuador S.A.Guayaquil
- Cepromar S.A.Guayaquil
- Yes Fish.S.AJaramijo
- Castro Narvaez Natalia del Lourdes CompanySantiago De Pillaro
- Transcity S.A.Guayaquil
- Proimec S.A.Manta
- PCC Congelados & Frescos S.A.Huaquillas
- CeproFish S.A.Guayaquil
- Industrial Pesquera Santa Priscila S.A.Guayaquil
- Reypezpacific S.A.Esmeraldas
- Frozen Tropic Cia. Ltda.Quito
- Grupo Degfer Cia LtdaManta
- Universal Sweet IndustriesGuayquil
- Admichonta S.A.Santo Domingo De Onzole
- Finca El EdenSanto Domingo
- Industrias Lacteas Toni S.A.Guayaquil
- Gustavo Patricio Espinosa LuceroQuito
- Ocampo Iza Jorge NexarEl Carmen
- Roberto Soto RomeroSanto Domingo
- Frigolab San Mateo Cia. LtdaJaramigo
- Leaf Just Fresh S.A.Quito
- Saenz Saenz Felipe RamiroQuito
- Ritcymar S.A.Guayaquil
- Miyaquil SAGuayaquil
- ZaphiredelcorQuito
- Refin S.A.Guayaquil
- Transmarina C.A.Montecristi
- Pesnusan Cia LtdaManta
- Industrias Lacteas Toni S.A.Guayaquil
- Ocean Fish, S.A.Manta
- Jourdan Cabot GrayPalora
- Jourdan Cabot GrayRircay
- Pacal Import & ExportEl Carmen
- Agricola Palmeiras Agripal S.AGuayaquil
- Mardex, S.A.Manta
- Galo Perez (GP)Santo Domingo
- Guayas Base Ubesa Grower GroupGuayaquil
- Jorge CadenaImbabura
- Exportaciones Durexporta S.A.Pascuales
- Jose Vicente Guerra DelgadoGuayaquil
- Translatin S.A.Guayaquil
- Exportadora la SerranitaQuito
- Frigorifico y LaboratorioJaramijo
- Frozenpac S.A. Congelados Pacifico SeafoodQuito
- Costapesca, CIA. LTDAQuito
- Escualem S.A.Guayaquil
- Docapes Pescados Camarones y Mariscos S.A.El Malecon De Santa Rosa Salinas
- Ecuafish S.A.ESMERALDAS
- Promarosa Productos Del Mar Ltda.Salinas
- Anibal PomasquiUrquiqui
- Empacadora DiamanteESMERALDAS
- Proyimar S.A.Guayaquil
- Promarisco S.A.Guayaquil
- Ecuaminot S.A.Salinas
- Frigolandia, SAGuayaquil
- Nelly del Carmen Alvarez CedenoGuayaquil
- Tulio LoorManabi
- Wilinton CetreSacha.
- Eladio Yari (Ey01)Sacha
- Roberto MoralesEl Carmen
- Phillips Seafood Ecuador, CAGuayaquil
- Dager Pesca Bien SA DagpesGuayaquil
- Agrol S.A.Manta
- Star Company S.A.Guayaquil
- Antonio EndaraPimampiro
- Emprede S.A.Tarqui
- Clarich S.A.Guayaquil
- Empacadora SuperiorGuayllabamba
- Enlatadora Ecuatoriana De AlimentosGuayaquil
- Industria Alimenticia S AAmbato
- Industrial Pesquera Monteverde C A (INPECA)Guayaquil
- Industrial Pesquera Monteverde CA (Inpeca)Monteverde
- Fincas Jofidd SaYaruqui
- ErikaSan Luis
- Ivan MarriotEl Carmen
- Carlos ZambranoEl Carmen
- Galatuna S.A.Isla Isabela, Galapagos
- Asertivaservi S.ASanto Domingo de Onzole
- Asertivaservi SAGuayaquil
- Good FishQuito
- Hacienda BejucalGuayas
- Oceaninvest S.A.Guayaquil
- Jorge Palma RamirezPichincha
- Exofrut S.A.Guayaquil
- Highland Gourmet S.A.Santo Domingo de los Colorados
- Jose ParedesSanto Domingo De Los Colorado
- Luis ZuletaPimampiro
- Patricio CabreraPimampiro
- Liber Dolores Ramirez CevallosSanto Domingo
- Peslasa S.A.Guayaquil
- Seadiamond s.a.Guayaquil
- Industrias Del Mar Lubar Cia LtdManta
- Produsa S.A.- Importadora y ExportadoraGuayaquil
- DimaworkGuayaquil
- Pacific Fish S.C.C.Quito
- Camaronera Y Pesquera Acuario S.A.Guayaquil
- Hectorosa S.A.Guayaquil
- Natural Select S.a.Guayaquil
- Agriexell s.aGuayaquil
- Bajespec, S. A.Salinas
- Criaderos Acuaticos La GuitaGuayaquil
- Ecuafresco SA PlantaManta
- Ecuamar S AGuayaquil
- Exportadora GamexCorretero Monta
- Fortumar Ecuador S AGuayaquil
- Frigorificos Y Conservas Narinas (Fricomsa)Guayaquil
- Frumaco S AGuayaquil
- Mariscos Y Crustaceos (Marcrusa)Guayaquil
- Paexport S AGuayaquil
- Rader SaGuayaquil
- Gambas del Pacifico S.A.Guayaquil
- EgbasaBahia De Caraquez
- Empacadora ProdemarManabi
- Neptuno Cia, Ltda.Jaramijo
- Pescazul S.AGuayaquil Q
- Tesalia S.A.Quito
- Columba RobinPimampiro
- Comexgar Cia. Ltda.Santa Domingo
- Jolfre YanezPimampiro
- Luis ChalacanPimampiro
- Maria CampuezImbabura
- Maria SevillanoSan Rafael
- Produsa S.A.Guayquil
- Roberto Flor FreireSanto Domingo
- Sopesca C.A.Guayaquil
- Terra-FertilQuito
- Alra ExportSalinas
- Analore, S.A.Manta
- Boris Buenaventura TrujilloManta
- Brimon S.A.Guayaquil
- Comercial Santana CedenoManta
- Conservas Marinas, S AEsmeraldas
- Crimaxi S.ASanta-Rosa,Salinas, Guayaquil
- Doblertel s.a.Guayaquil
- Ecuador Mar Fishing Co. EmarfisaGuayaquil
- el rosario ersa s.a.Guayaquil
- Estemar S A aka Stella MarisGuayaquil
- Exportadora Del Oceano Pacifico OceanpacGuayaquil
- Exportadora Yifar Express Sudamerica S A EmpacadoraGuayaquil
- FishcorpJaramijo
- Frigorificos Acuario S A (FRACUSA)Guayaquil
- GrumodusGuayaquil
- Hantamar S.A.Guayaquil
- Henmor S.A.Manta
- Industria Exportadora Del Pacifico Cia LtdaGuayaquil
- Julieta MeraGuayaquil
- Mahi Mahi EcuadorQuito
- Makaira A.C.PGuayaquil
- Mardelit Cia LtdaManta
- Mariscos de Chupadores Chupamar S.A.Guayaquil
- Neptuna CIA LtdaGuayaquil
- P.A.B. SeafoodQuito
- Patricio Villamar/ Agroseafood S.A.Guayaquil
- Pefresco MarManta
- Pefresman Cia LtdaManta
- Pesca Ecuatoriana Cia LtdaManta
- Pesquera Progalca C.A.Guayaquil
- Promarosa (Productos del Mar Santa Rosa Cia. Ltda.)Guayaquil
- Promarpasa Productos Del Mar PaticosGuayaquil
- Sandra Ronquillo PerezSalinas
- Super Fresco SeafoodQuito
- Trife F Fresh Fishes Finest S.AGuayaquil
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Buying from Ecuador?
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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.