FDA import refusals
FDA import refusals from South Africa
Food, dietary supplements and animal food · October 2016 to October 5, 2026 · how the data is collected
FDA refused 235 shipment lines from South Africa between October 2016 and October 2026, including 25 in 2026 through October 5, 2026; the most common charges were NUTRIT LBL, UNAPPROVED and FILTHY, and the most refused category was dietary supplements.
Data from FDA public records, last checked .
- 235
- refused shipment lines since October 2016
- 25
- refused so far in 2026
- 252
- South Africa firms with an FDA record
- 52
- firms on an active import alert
Refusals from South Africa by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 25 | |
| 2025 | 38 | +124% |
| 2024 | 17 | -55% |
| 2023 | 38 | +171% |
| 2022 | 14 | +133% |
| 2021 | 6 | -33% |
| 2020 | 9 | -81% |
| 2019 | 47 | +176% |
| 2018 | 17 | +6% |
| 2017 | 16 | |
| 2016 (from Oct) | 8 |
Why FDA refused South Africa 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.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| NUTRIT LBL | Nutrition information missing from label | 62 | 19% |
| UNAPPROVED | Unapproved new drug | 56 | 18% |
| FILTHY | Filthy, putrid or decomposed substance | 35 | 11% |
| UNSAFE COL | Color additive unsafe under section 721 | 35 | 11% |
| LACKS N/C | Net quantity statement missing | 26 | 8% |
| PESTICIDE | Pesticide chemical residue | 26 | 8% |
| DIETARYLBL | Not identified as a dietary supplement | 25 | 8% |
| LIST INGRE | Ingredients not listed | 25 | 8% |
| COLOR LBLG | Artificial coloring not declared | 14 | 4% |
| DIRSEXMPT | Appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. | 14 | 4% |
What FDA refused from South Africa, by product category
FDA product categories, most refused first. Open a category for its product, charge and firm tables.
| Category | Most refused products | Lines |
|---|---|---|
| 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.; Vitamin c (ascorbic acid) | 84 |
| Berries and citrusFruit and Fruit Products (berries, citrus and core fruits) | Raisins (dried grapes) (berry); Grapes (berry); Raisins, dried or paste | 47 |
| Nuts and seedsNuts and Edible Seeds | Macadamia, shelled | 12 |
| SeafoodFishery/Seafood Products | Mahi mahi; Fish paste, fishery products, n.e.c.; Fishery products, n.e.c. | 11 |
| Soft drinks and waterSoft Drinks and Waters | Carbonated soft drink, n.e.c.; Noncarbonated soft drink, n.e.c.; Energy drink caffeine, carbonated, n.e.c. | 10 |
| Candy and chewing gumCandy without Chocolate, Candy Specialties, and Chewing Gum | Soft candy without nuts and fruit, n.e.c. (without chocolate); Bubble gum (without chocolate); Candy bar or pieces (not caramel or fondant), hard, with fruit (without chocolate) | 10 |
| Bakery productsBakery Products, Doughs, Bakery Mixes, and Icings | Butter/butter flavored filled/iced cookies,biscuits and wafers; Biscuits; Mixed plain cookies,biscuits and wafers | 9 |
| SoupsSoups | Mushroom soup, dried; Mixed vegetable soup, dried; Potato soup, creamed, dried | 9 |
| Tropical and pit fruitFruit and Fruit Products (pit, subtropical and tropical fruits) | Peach, dried or paste; Berries and subtropica/tropical fruits, mixed, dried or paste; Mixed fruit, jam, jelly, preserves, marmalade, butter or candied, n.e.c. | 8 |
| Chocolate and cocoaChocolate and Cocoa Products | Chocolate candy bar, with nuts and fruit; Chocolate candy bar, without nuts and fruit | 6 |
| Meal replacementsDietary Conventional Foods and Meal Replacements | Dietary conventional foods, n.e.c. | 5 |
| Grains and starchWhole Grains, Milled Grain Products, and Starch | Rice, processed (packaged) n.e.c.; Rice, plain (white or polished) processed (packaged) | 3 |
| Root vegetables and mushroomsVegetables and Vegetable Products (root and tuber vegetables, fungi) | Mixed vegetables, with sauce, n.e.c.; Onion bulb (yellow, white, red, etc.) (root & tuber vegetable) | 3 |
| Coffee and teaCoffee and Tea | Tea, green; Tea, n.e.c. | 3 |
| Sauces and prepared mealsMultiple Food Dinners, Gravies, Sauces, and Specialties | Sauces, n.e.c. | 3 |
| Vegetables (legumes and leafy)Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | Navy (white) beans (baked beans, pork & beans), in sauce | 2 |
| SweetenersFood Sweeteners (Nutritive) | Sugar products, n.e.c. | 2 |
| Animal feed byproductsByproducts for Animal Feeds | Animal fat slaughtered mammal by prod | 2 |
| Cereals and breakfast foodsCereal Preparations, Breakfast Foods | Cereal preparations not elsewhere mentioned, n.e.c. | 1 |
| Snack foodsSnack Food Items | Snack foods not elsewhere mentioned, n.e.c. | 1 |
| Ice creamIce Cream and Related Products | Custard mix | 1 |
| Dressings and condimentsDressings and Condiments | Mayonnaise | 1 |
| SpicesSpices, Flavors, and Salts | Natural extract or flavor, n.e.c. | 1 |
| Food additives (flavors and colors)Food Additives for Human Use (flavors, colors, leavening and other agents) | Color adjuncts (food additives for human use) | 1 |
Most refused products from South Africa
FDA's product descriptions on the refused lines, grouped case-insensitively.
| Product | Lines | Share |
|---|---|---|
| Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. | 43 | 18.3% |
| Raisins (dried grapes) (berry) | 32 | 13.6% |
| Herbals & botanicals (not teas), n.e.c. | 21 | 8.9% |
| Macadamia, shelled | 12 | 5.1% |
| Grapes (berry) | 9 | 3.8% |
| Mahi mahi | 7 | 3.0% |
| Vitamin c (ascorbic acid) | 7 | 3.0% |
| Butter/butter flavored filled/iced cookies,biscuits and wafers | 6 | 2.6% |
| Mushroom soup, dried | 6 | 2.6% |
| Peach, dried or paste | 6 | 2.6% |
FDA import alerts that list South Africa firms
11 alerts list at least one firm in South Africa: 52 firms on a red list, 52 firms on any list.
| Alert | Covers | Red | Green |
|---|---|---|---|
| 45-02 | Foods with illegal or undeclared colors | 27 | |
| 99-08 | Processed human and animal foods: pesticides | 12 | |
| 99-19 | Food products: Salmonella | 5 | |
| 99-39 | Imported foods that appear to be misbranded | 4 | |
| 16-120 | Seafood from processors not in compliance with HACCP | 3 | |
| 99-21 | Foods with undeclared added sulfiting agents | 2 | |
| 16-39 | Ready-to-eat seafood: Listeria monocytogenes | 1 | |
| 41-03 | Adulterated and Misbranded Medical Foods | 1 | |
| 71-04 | Animal food: Salmonella | 1 | |
| 99-36 | Low-acid canned/acidified foods: process information | 1 | |
| 99-37 | Low-acid canned/acidified foods without scheduled process | 1 |
South Africa 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.
| Firm | City | FDA records |
|---|---|---|
| Desert Raisins (Pty) Ltd | Kanoneiland | 22 |
| Ocksan Trading Pty Ltd T/A Aviomed | Cape Town | 13 |
| Neogenesis Health Manufacturing | Strydompark | 11 |
| Green Farms Nut Company Levubu (Pty) Ltd | Levubu | 10 |
| Tiger Brands | Johannesburg | 8 |
| Pristine Seafoods (Pty)Ltd | Germiston | 7 |
| Premier Foods | Waterfall City | 7 |
| Jigsimur Health Plus Drink | Cape Town | 7 |
| Cape Dried Fruit Packers (Pty) Ltd. | Montagu | 6 |
| Verve Dynamics (Pty) Ltd. | Somerset-West | 6 |
Latest refusals from South Africa
The 20 most recent refused lines, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Tiger Brands LtdBoksburg, South Africa | Navy (white) beans (baked beans, pork & beans), in sauce | LACKS N/CNUTRIT LBLNO PROCESS | Source | |
| Tiger Brands LtdBoksburg, South Africa | Navy (white) beans (baked beans, pork & beans), in sauce | NO PROCESS | Source | |
| Tiger Consumer BrandsCape Town, South Africa | Rice, processed (packaged) n.e.c | PESTICIDE | Source | |
| Tiger Consumer BrandsCape Town, South Africa | Rice, processed (packaged) n.e.c | PESTICIDE | Source | |
| Tiger Consumer Brands Pty LtdPaarl, South Africa | Strawberry, jam, jelly, preserves, marmalade, butter and candied | UNSAFE COL | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTVETDRUGRES+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTVET DR LBLNEW VET DR | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTVETDRUGRESVET DR LBL | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTVET DR LBLNEW VET DR | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTVET DR LBLNEW VET DR | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTVETDRUGRES+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTVET DR LBLNEW VET DR | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTVETDRUGRESVET DR LBL | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Tiger Consumer BrandsCape Town, South Africa | Rice, plain (white or polished) processed (packaged) | PESTICIDE | Source | |
| Mondelez South Africa (Pty) LtdSandton, South Africa | Bubble gum (without chocolate) | UNSAFE COL | Source |
Questions about FDA refusals from South Africa
- How many South Africa shipments did FDA refuse in 2026?
- FDA refused 25 shipment lines from South Africa in 2026 through October 5, 2026, compared with 38 in 2025 (a full year).
- Why does FDA refuse food from South Africa?
- FDA records a charge code on every refused shipment line. For South Africa the most frequent are NUTRIT LBL (nutrition information missing from label, 62 lines), UNAPPROVED (unapproved new drug, 56 lines) and FILTHY (filthy, putrid or decomposed substance, 35 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 South Africa firms have the most FDA refusals?
- In SupplierRadar's records the South Africa firms with the most FDA records (refusals, import alert listings and other events) are Desert Raisins (Pty) Ltd (Kanoneiland) with 22 records, OCKSAN TRADING PTY LTD T/A AVIOMED (Cape Town) with 13 records and NEOGENESIS HEALTH MANUFACTURING (Strydompark) with 11 records. Each firm's page lists every record with its FDA source.
- Which FDA import alerts list South Africa firms?
- As of October 25, 2026, 11 FDA import alerts list at least one firm in South Africa. The alerts with the most South Africa listings are Import Alert 45-02 (27 firms), Import Alert 99-08 (12 firms) and Import Alert 99-19 (5 firms).
- How many South Africa firms are on an FDA import alert red list?
- As of October 25, 2026, 52 South Africa firms are on the red list of at least one FDA import alert in SupplierRadar's records, and 52 firms are on any list.
All South Africa suppliers with FDA records (103)
Every South Africa 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.
- Tiger Brands LtdBoksburg
- Tiger Consumer BrandsCape Town
- Tiger Consumer Brands Pty LtdPaarl
- Ocksan Trading Pty Ltd T/A AviomedCape Town
- Tiger BrandsJohannesburg
- Mondelez South Africa (Pty) LtdSandton
- Jigsimur SA OriginalCape Town
- Monster Energy Beverage Company of South Africa (Pty) LtdGermiston
- Unilever South AfricaDurban
- Coca Cola Beverage South Africa Proprietary LimitedOlifantsfontein
- Jigsimur Health Plus DrinkCape Town
- Moniquemobi Pty LtdCape Town
- Pioneer Foods GroceriesUpington
- Masushita TradingPretoria
- VelobioticsGermiston
- Oryx K9Stilfontein
- The 8TH ElementCape Town
- RedSun Dried Fruit and Nuts (pty), Ltd.Keimoes
- Granor Passi (Pty) LtdPolokwane
- Rhodes Food Group Pty LtdPaarl
- Sceletium Source AfricaWilderness
- Associated Fruit Processors (Pty) Ltd.Grabouw
- Western Cape Fruit Processors (Pty) LtdGrabouw
- Verve Dynamics (Pty) Ltd.Somerset-West
- Neogenesis Health ManufacturingStrydompark
- Carpe Diem RaisinsUpington
- Lowveld Nut ProcessingNelspruit
- Desert Raisins (Pty) LtdKanoneiland
- Premier FoodsWaterfall City
- Cape Herb & Spice - A division of Libstar Operations (Pty) LtdCape Town
- Cape Hothouse Vegetables CCMalmesbury
- Green Farms Nut Company White River PTY LtdWhite River
- Langeberg Foods (PYT) Ltd.Ashton
- Cape Dried Fruit Packers (Pty) Ltd.Montagu
- Ceres Friut Juices (Pty) LtdPaarl
- Breakwater Products (Pty) LtdHoutbay
- Unilever South AfricaIsipingo
- Granor Passi Langkloof (Pty) LtdLouterwater
- Nutrapharm Manufacturing IndustriesBallito
- Afrigetics CCWilderness
- Multi Mineral SupplementGeorge
- Clover Sa LtdRoodepoort
- Sally Williams Fine Foods (Pty) LtdSandton
- Dynamic Commodities (Pty) LtdPort Elizabeth
- Prosperitas Foods Pty LtdFriersdale
- Delfran (Pty) LtdCenturion
- Green Farms Nut Company Levubu (Pty) LtdLevubu
- Khayelitsha CookiesParow
- Massam's ConfectionerySezela
- Rhodes Food Group (Pty) Ltd.Verulam
- National Brands Limited - WestmeadPinetown
- Ina Paarmans Kitchen Pty LtdDiep River
- Quay Marine FactoryCape Town
- Alclin Pty LtdRiversdale
- Commercial Cold StoragePort of Cape Town
- Jla Pty LtdKnysna
- Dna BiopharmCapetown
- Indian Ocean Export CompanyDurban
- South African Raisins Pty LtdMarchand, North Cape S.
- Food Corp (Proprietary) LtdRandfontein
- Snackworks - Isando Biscuit FactoryKempton Park
- Golden CapeDurbanville
- Pioneer Foods Groceries (Pty) LtdCeres
- Dairboard Holdings LtdHarare
- Pioneer Foods (Pty) LtdPaal
- JAB Dried Fruit Products (Pty) Ltd.Nelspruit
- Rooibos LimitedClanwilliam
- Rhodes Food Group (Pty) Ltd.Wellington
- Pristine Seafoods (Pty)LtdGermiston
- K.Paulsen BotanicalsSwellendam
- Hersol Manufacturing Laboratories ccJohannesburg
- Tiger Food Brands LimitedCape Town
- Tiger Food Brands Ltd - CulinaryDurbanville
- Simba IsandoKempton Park
- Lads Management CcBellville
- Silverstream Mushroom Prods. (Pty) Ltd.Bergvlei
- Tuna Marine (Pty) Ltd.Cape Town
- Skimmelberg Pty LtdClanwilliam
- Leviti S Distribution CcJohannesburg
- Imbuko Wines (Pty) LtdWellington
- Coco-Cola Canners of Southern Africa (Pty) Ltd.Wadeville
- Beacon Sweets & Chocolates LtdDurban
- Sunspray Food Ingredients (Pty) LtdJohannesburg
- Pioneer FoodsBellville
- SAD, Division of Pioneer Foods LTDWellington
- Tigerbrands Snacks, Treats and BeveragesDurban
- Kalahari Raisins (Pty) LtdFriersdales
- Kaytrad Commodities (Pty) Ltd.Cape Town
- Doornfontein Hoodia FarmCape Town
- Beacon Sweets and ChocolatesMobeni, Durban
- Bromor Foods (Pty) Ltd.Cape Town
- Cadbury (Pty) LtdPort Elizabeth
- Clover S.A.Weltevreden Park
- Mondelez GlobalJohannesburg
- Nabisco South AfricaKempton Park
- NestleJohannesburg
- Langeberg Foods LimitedBellville
- Latcom CcPretoria
- Natpro Spicenet LtdNew Germany
- Ortone & Lake Marketting CCDurbans
- Skimmelberg Fynbos Oils (Pty) LtdCape Town
- Dried Ocean ProductsPort Elizabeth
- Hout Bay Fishing Industries (PTY) LTDCape Town
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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.