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FDA import refusals

FDA import refusals from Germany

Food, dietary supplements and animal food · October 2016 to October 9, 2026 · how the data is collected

FDA refused 649 shipment lines from Germany between October 2016 and October 2026, including 45 in 2026 through October 9, 2026; the most common charges were NUTRIT LBL, NO ENGLISH and UNSAFE COL, and the most refused category was dietary supplements.

Data from FDA public records, last checked .

649
refused shipment lines since October 2016
45
refused so far in 2026
480
Germany firms with an FDA record
53
firms on an active import alert

Refusals from Germany 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.01002003002016 (from October 1): 35 refusal lines’162017: 233 refusal lines233’172018: 54 refusal lines’182019: 46 refusal lines’192020: 19 refusal lines’202021: 31 refusal lines’212022: 34 refusal lines’222023: 31 refusal lines’232024: 60 refusal lines’242025: 61 refusal lines’252026 (year to date): 45 refusal lines45’26*
* 2026 is year to date, through October 9, 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)45
202561+2%
202460+94%
202331-9%
202234+10%
202131+63%
202019-59%
201946-15%
201854-77%
2017233
2016 (from Oct)35

Why FDA refused Germany 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 Germany
Charge codeMeaningLinesShare
NUTRIT LBLNutrition information missing from label19823%
NO ENGLISHRequired label information not in English16720%
UNSAFE COLColor additive unsafe under section 72111313%
LACKS N/CNet quantity statement missing8810%
UNAPPROVEDUnapproved new drug597%
FALSEFalse or misleading labeling486%
LABELINGFair Packaging and Labeling Act486%
LACKS FIRMManufacturer name and address missing465%
LIST INGREIngredients not listed415%
NCONTACTNo U.S. adverse event contact on supplement label405%

What FDA refused from Germany, by product category

FDA product categories, most refused first. Open a category for its product, charge and firm tables.
FDA import refusals from Germany by product category
CategoryMost refused productsLines
Dietary supplementsVitamins, Minerals, Proteins, and Unconventional Dietary SpecialtiesVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.; Vitamin, n.e.c.; Herbals & botanicals (not teas), n.e.c.167
Baby foodBaby (Infant and Junior) Food ProductsMilk base infant formula product (0-12 months), powder formula; Milk base infant formula product (0-12 months), ready to feed; Baby and junior food n.e.c.149
Bakery productsBakery Products, Doughs, Bakery Mixes, and IcingsNut cookie,biscuit,wafer dough; Nut filled/iced cookies,biscuits and wafers; Oatmeal filled/iced cookies,biscuits and wafers96
Chocolate and cocoaChocolate and Cocoa ProductsChocolate candy pieces, without nuts and fruit; Chocolate candy bar, with nuts and fruit; Chocolate candy bar, without nuts and fruit35
Candy and chewing gumCandy without Chocolate, Candy Specialties, and Chewing GumCandy specialties, n.e.c. (without chocolate); Hard candy with fruit, n.e.c. (without chocolate); Hard candy without nuts and fruit, n.e.c. (without chocolate)26
SeafoodFishery/Seafood ProductsSalmon (humpback, silver, king, sockeye, etc.), cold smoked, fish; Herring; Herring, hot smoked, fish23
Coffee and teaCoffee and TeaTea, camomille, chamomile (tea substitute); Tea, green; Tea, n.e.c.18
Meal replacementsDietary Conventional Foods and Meal ReplacementsDietary conventional foods, n.e.c.; Meal replacements (not labeled for treatment of disease); Foods with supplemental nutrients added, with or without artifical sweetners18
Dressings and condimentsDressings and CondimentsMustard, prepared; Salad dressing, standardized; Catsup16
Sauces and prepared mealsMultiple Food Dinners, Gravies, Sauces, and SpecialtiesSteak and other meat sauce; Sauces, n.e.c.; Gravies, n.e.c.15
Vegetables (legumes and leafy)Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables)Parsley (leaf & stem vegetable); Kale (leaf & stem vegetable); Tomato, dried11
SpicesSpices, Flavors, and SaltsSpices and seasoning, ground, cracked, with salt, n.e.c.; Mixed spice and seaonings, without salt, n.e.c.; Spices, flavors and salt not mentioned elsewhere, n.e.c.11
Snack foodsSnack Food ItemsGrain snacks (whole, split), n.e.c., baked; Potato snacks (flavored or unflavored), vegetable snacks (other than pulses) baked; Banana snacks, fruit snack foods, baked9
Berries and citrusFruit and Fruit Products (berries, citrus and core fruits)Cranberry juice, berry juice or concentrates; Apple, core fruit juices or concentrates; Grape juice, berry juice or concentrates8
Tropical and pit fruitFruit and Fruit Products (pit, subtropical and tropical fruits)Peach, dried or paste; Tamarind (subtropical and tropical fruit); Citrus and subtropical/tropical fruit, mixed, flavored jams, jellies, marmalades, butters and candie8
Cereals and breakfast foodsCereal Preparations, Breakfast FoodsCereal preparations not elsewhere mentioned, n.e.c.; Corn flakes,puffs,krispies,loops ready to eat; Rice flakes,puffs,krispies,loops ready to eat7
Beverage basesBeverage BasesBeverage base of non-fruit origin, liquid, n.e.c.; Fruit beverage base, n.e.c.7
Pet foodPet and Laboratory Animal FoodsCombination products, pet treats; Comb prod pet cat food; Pet cat food n.e.c.7
Nuts and seedsNuts and Edible SeedsAlmond, shelled; Filbert, hazelnut, shelled; Nuts, in shell, n.e.c.4
Root vegetables and mushroomsVegetables and Vegetable Products (root and tuber vegetables, fungi)Vegetable & vegetable products not mentioned elsewhere, n.e.c.; Fungi products not mentioned elsewhere, n.e.c.4
Milk and butterMilk, Butter, and Dried Milk ProductsMilk, dried; Milk, flavored, low fat; Whey protein concentrate3
SoupsSoupsBroth, n.e.c. (meat and/or vegetable stock); Cheese soup, dried2
Grains and starchWhole Grains, Milled Grain Products, and StarchWheat flour, whole1
Vegetable proteinVegetable Protein Products (Simulated Meats)Cereal base meat extenders, wheat protein, etc.1
Food additives (flavors and colors)Food Additives for Human Use (flavors, colors, leavening and other agents)Leavening agents (food additives for human use)1
Animal feedNon-Medicated Animal FeedsAnimal feeds, n.e.c.1
Animal feed byproductsByproducts for Animal FeedsByprod for animal, n.e.c.1

Most refused products from Germany

FDA's product descriptions on the refused lines, grouped case-insensitively.
Most refused products from Germany
ProductLinesShare
Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.9214.2%
Milk base infant formula product (0-12 months), powder formula8112.5%
Nut cookie,biscuit,wafer dough7411.4%
Milk base infant formula product (0-12 months), ready to feed203.1%
Baby and junior food n.e.c.172.6%
Vitamin, n.e.c.162.5%
Chocolate candy pieces, without nuts and fruit142.2%
Herbals & botanicals (not teas), n.e.c.142.2%
Mustard, prepared111.7%
Dietary conventional foods, n.e.c.101.5%

FDA import alerts that list Germany firms

16 alerts list at least one firm in Germany: 53 firms on a red list, 53 firms on any list.
Import alerts listing firms in Germany
AlertCoversRedGreen
99-08Processed human and animal foods: pesticides11
45-02Foods with illegal or undeclared colors10
99-39Imported foods that appear to be misbranded9
99-19Food products: Salmonella8
99-36Low-acid canned/acidified foods: process information5
54-14Supplements from firms not meeting supplement GMP3
99-38Low-acid canned/acidified foods: inadequate process control3
16-39Ready-to-eat seafood: Listeria monocytogenes2
40-05Adulterated and misbranded infant formula2
54-16Foods/supplements with active pharmaceutical ingredient2
71-04Animal food: Salmonella2
99-22Undeclared or mislabeled major food allergens2

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

Germany 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.
Germany firms with the most FDA records
FirmCityFDA records
Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm134
Lebkuchen-Schmidt GmbH & Co. KGNuremberg82
Carl Kuhne KG (GmbH & Co.)Straelen15
Denk Pharma GmbH & Co. KGMunich14
SanPharma GmbHHamburg13
vitOrgan Arzneimittel GmbHOstfildern12
Cfs Gmbh KemptenKempten (Allgau)12
Nestle Deutschland AGFrankfurt am Main12
Martin Bauer Gmbh & Co. KGVestenbergsgreuth11
Queisser Pharma Gmbh & Co.Flensburg11

Latest refusals from Germany

The 20 most recent refused lines, each with its FDA source.
Latest FDA import refusals from Germany
DateFirmProductCharges
Froximun AgSchlanstedt, GermanyVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cUNAPPROVEDSource
Holle Europe GmbHLorrach, GermanyGoat milk infant based formula product (0-12 months), powder formulaLIST INGREFALSELACKS N/CSource
Biologische Heilmittel Heel GmbhBaden-Baden, GermanyVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNOT LISTEDSource
Cavendish & Harvey Confectionery GmbHKaltenkirchen, GermanyCandy specialties, n.e.c. (without chocolate)LABELINGNUTRIT LBLSource
Linden-Apotheke M. Spiegel E.K.Graefenhainichen, GermanyVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNOT LISTEDNO ENGLISHFRNMFGREG+1Source
Milchwerke "Mittelelbe" GmbHStendal, GermanyMilk base infant formula product (0-12 months), powder formulaINSANITARYSource
Milchwerke "Mittelelbe" GmbHStendal, GermanyMilk base infant formula product (0-12 months), powder formulaINSANITARYSource
Schuck''''S Cmbh PharmazieSchwaig B. Nurnberg, GermanyVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNOT LISTEDNO ENGLISHFRNMFGREG+1Source
ABNOBA GmbHNiefern-Oschelbronn, GermanyHerbals & botanicals (not teas), n.e.cUNAPPROVEDSource
Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, GermanyMilk base infant formula product (0-12 months), ready to feedLACK NOTIFFALSENO ENGLISHSource
Merck Kommanditgesellschaft auf AktienDarmstadt, GermanyVitamin b1 (thiamine)UNAPPROVEDSource
Merck Kommanditgesellschaft auf AktienDarmstadt, GermanyVitamin b1 (thiamine)UNAPPROVEDSource
ABNOBA GmbHNiefern-Oschelbronn, GermanyAshwagandha (herbal & botanicals, not teas)UNAPPROVEDSource
Schuck''''S Cmbh PharmazieSchwaig B. Nurnberg, GermanyVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cUNAPPROVEDSource
SANUM-Kehlbeck GmbH & Co. KGHoya, GermanyVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDRUG GMPSSource
Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, GermanyMilk base infant formula product (0-12 months), powder formulaINCONSPICULACKS N/CSource
Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, GermanyMilk base infant formula product (0-12 months), powder formulaINCONSPICULACKS N/CSource
Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, GermanyVegetables, n.e.c. (baby)NEEDS FCENO PROCESSSource
Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, GermanyVegetables, n.e.c. (baby)NEEDS FCENO PROCESSSource
Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, GermanyFruit flavored drinkNEEDS FCENO PROCESSSource

Questions about FDA refusals from Germany

How many Germany shipments did FDA refuse in 2026?
FDA refused 45 shipment lines from Germany in 2026 through October 9, 2026, compared with 61 in 2025 (a full year).
Why does FDA refuse food from Germany?
FDA records a charge code on every refused shipment line. For Germany the most frequent are NUTRIT LBL (nutrition information missing from label, 198 lines), NO ENGLISH (required label information not in English, 167 lines) and UNSAFE COL (color additive unsafe under section 721, 113 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 Germany firms have the most FDA refusals?
In SupplierRadar's records the Germany firms with the most FDA records (refusals, import alert listings and other events) are Hipp GmbH & CO Vertrieb KG (Pfaffenhofen A.d.ilm) with 134 records, Lebkuchen-Schmidt GmbH & Co. KG (Nuremberg) with 82 records and Carl Kuhne KG (GmbH & Co.) (Straelen) with 15 records. Each firm's page lists every record with its FDA source.
Which FDA import alerts list Germany firms?
As of October 26, 2026, 16 FDA import alerts list at least one firm in Germany. The alerts with the most Germany listings are Import Alert 99-08 (11 firms), Import Alert 45-02 (10 firms) and Import Alert 99-39 (9 firms).
How many Germany firms are on an FDA import alert red list?
As of October 26, 2026, 53 Germany firms are on the red list of at least one FDA import alert in SupplierRadar's records, and 53 firms are on any list.

All Germany suppliers with FDA records (77)

Every Germany 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.