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FDA import refusals

FDA import refusals from Malaysia

Food, dietary supplements and animal food · October 2016 to September 10, 2026 · how the data is collected

FDA refused 658 shipment lines from Malaysia between October 2016 and September 2026, including 29 in 2026 through September 10, 2026; the most common charges were UNAPPROVED, NUTRIT LBL and LISTERIA, and the most refused category was dietary supplements.

Data from FDA public records, last checked .

658
refused shipment lines since October 2016
29
refused so far in 2026
382
Malaysia firms with an FDA record
130
firms on an active import alert

Refusals from Malaysia 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.0501001502002016 (from October 1): 1 refusal lines’162017: 55 refusal lines’172018: 45 refusal lines’182019: 84 refusal lines’192020: 14 refusal lines’202021: 188 refusal lines188’212022: 78 refusal lines’222023: 31 refusal lines’232024: 66 refusal lines’242025: 67 refusal lines’252026 (year to date): 29 refusal lines29’26*
* 2026 is year to date, through September 10, 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)29
202567+2%
202466+113%
202331-60%
202278-59%
2021188+1243%
202014-83%
201984+87%
201845-18%
201755
2016 (from Oct)1

Why FDA refused Malaysia 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 Malaysia
Charge codeMeaningLinesShare
UNAPPROVEDUnapproved new drug29439%
NUTRIT LBLNutrition information missing from label11415%
LISTERIAListeria monocytogenes10814%
NCONTACTNo U.S. adverse event contact on supplement label547%
LIST INGREIngredients not listed496%
DIETARYLBLNot identified as a dietary supplement324%
UNSAFE ADDFood additive unsafe under section 409294%
HEALTH CUnauthorized nutrient content or health claim274%
LABELINGFair Packaging and Labeling Act253%
FILTHYFilthy, putrid or decomposed substance243%

What FDA refused from Malaysia, by product category

FDA product categories, most refused first. Open a category for its product, charge and firm tables.
FDA import refusals from Malaysia 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.; Herbals & botanicals (not teas), n.e.c.; Royal jelly (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.)325
SeafoodFishery/Seafood ProductsFish cakes, balls, etc., n.e.c.; Mahi mahi; Fish, n.e.c.162
SweetenersFood Sweeteners (Nutritive)Honey; Honey, n.e.c.37
Bakery productsBakery Products, Doughs, Bakery Mixes, and IcingsCake without custard or cream filling; Cheese filled crackers; Filled crackers n.e.c.24
Sauces and prepared mealsMultiple Food Dinners, Gravies, Sauces, and SpecialtiesBean curd, n.e.c. (multiple food specialties, side dishes & desserts); Curry paste; Sauces, n.e.c.18
Snack foodsSnack Food ItemsShrimp flavored chips, fried; Shrimp flavored chips, baked; Snack foods not elsewhere mentioned, n.e.c.17
Candy and chewing gumCandy without Chocolate, Candy Specialties, and Chewing GumLollipop (without chocolate); Candy without chocolate n.e.c.; Jellied candy, soft (jelly beans, gum drops, etc.), without nuts and fruit (without chocolate)15
Noodles and pastaMacaroni and Noodle ProductsNoodles, instant12
Tropical and pit fruitFruit and Fruit Products (pit, subtropical and tropical fruits)Citrus and other fruits, mixed; Coconut, subtropical and tropical fruit, juices, milk, creme, drinks and nectars; Lychee, lichee, litchi, leechee, juice, milk, creme, drink or nectar, sub/tropical fruit7
Coffee and teaCoffee and TeaCoffee, n.e.c.; Herbal coffee (blend of herbs, grains, fruits and nuts); Coffee, ground7
Chocolate and cocoaChocolate and Cocoa ProductsCocoa bean n.e.c.; Chocolate and cocoa, n.e.c.; Imitation chocolate and cocoa beverage base6
Gelatin and puddingsGelatin, Rennet, Pudding Mixes, and Pie FillingsPudding (pie filling) mix, n.e.c. (not custard)5
Root vegetables and mushroomsVegetables and Vegetable Products (root and tuber vegetables, fungi)Mixed vegetables, juice or drink, n.e.c.; Ginger root, dried or paste; Mushroom, common (agaricus bisporus), pieces and stems, sliced4
SoupsSoupsDried soup, n.e.c.; Soup, n.e.c.4
SpicesSpices, Flavors, and SaltsCapsicums (cayenne chili, hot peppers), ground, cracked (spice); Mixed spice and seaonings, without salt, n.e.c.; Mixed spice and seasonings, ground, cracked, without salt, n.e.c.3
Soft drinks and waterSoft Drinks and WatersSoft drink, milk based (chocolate flavored, etc.), noncarbonated2
Meal replacementsDietary Conventional Foods and Meal ReplacementsDietary conventional foods, n.e.c.; Foods with supplemental nutrients added, with or without artifical sweetners2
Milk and butterMilk, Butter, and Dried Milk ProductsMilk, dried1
Vegetables (legumes and leafy)Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables)Soybeans (see industry 37 for 'bean curd'), juice or drink1
Vegetable oilsVegetable Oils (Includes Olive Oil)Palm kernel oil, refined, single ingredient1
Baby foodBaby (Infant and Junior) Food ProductsCereal, n.e.c. (baby)1
Food additives (flavors and colors)Food Additives for Human Use (flavors, colors, leavening and other agents)Flavoring agents and adjuvants (food additives for human use)1
Food additives (stabilizers)Food Additives for Human Use (stabilizers, thickeners, other)Food additives for human use, n.e.c.1
Animal feedNon-Medicated Animal FeedsAnimal feeds, n.e.c.1
Animal feed byproductsByproducts for Animal FeedsCopra meal1

Most refused products from Malaysia

FDA's product descriptions on the refused lines, grouped case-insensitively.
Most refused products from Malaysia
ProductLinesShare
Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.22834.7%
Fish cakes, balls, etc., n.e.c.10516.0%
Herbals & botanicals (not teas), n.e.c.314.7%
Royal jelly (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.)253.8%
Honey243.6%
Vitamin, n.e.c.162.4%
Honey, n.e.c.132.0%
Noodles, instant121.8%
Mahi mahi101.5%
Fish, n.e.c.91.4%

FDA import alerts that list Malaysia firms

26 alerts list at least one firm in Malaysia: 130 firms on a red list, 130 firms on any list.
Import alerts listing firms in Malaysia
AlertCoversRedGreen
16-129Seafood products: nitrofurans27
45-02Foods with illegal or undeclared colors24
54-16Foods/supplements with active pharmaceutical ingredient21
99-39Imported foods that appear to be misbranded15
16-81Seafood products: Salmonella13
16-127Seafood: chloramphenicol11
99-19Food products: Salmonella6
36-04Honey and blended syrup: drug residues5
16-120Seafood from processors not in compliance with HACCP4
16-119Fish products from importer and processor combinations3
16-124Aquaculture seafood: unapproved drugs3
54-15Supplements and ingredients containing kratom3

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

Malaysia 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.
Malaysia firms with the most FDA records
FirmCityFDA records
Ql Foods Sdn. Bhd.Hutan Melintang108
Kingdom Honey SDN. BHD.Kuala Lumpur89
EtumaxPetaling63
Kingdom Honey Sdn BhdKuala Lumpur39
Dynamic Nutrition Sdn BhdPetaling Jaya20
Miaow Miaow Food Products Sdn. Bhd.Batu Pahat15
Phyto ScienceBandar Baru Bangi15
Labuan Food Industries Sdn BhdLabuan14
Rico Food Industries Sdn. Bhd.Kulim13
Biotivity SDN BHDBota10

Latest refusals from Malaysia

The 20 most recent refused lines, each with its FDA source.
Latest FDA import refusals from Malaysia
DateFirmProductCharges
Drs Secret Worldwide Manufacturing Sdn BhdSeberang Perai Tengah, MalaysiaCoffee, n.e.cDIETARYLBLSource
Golden Fresh Sdn BhdButterworth, MalaysiaShrimp & prawns, breadedUNSAFE ADDSource
Golden Fresh Sdn BhdButterworth, MalaysiaShrimp & prawns, breadedUNSAFE ADDSource
Golden Fresh Sdn BhdButterworth, MalaysiaShrimp & prawns, breadedUNSAFE ADDSource
Golden Fresh Sdn BhdButterworth, MalaysiaShrimp & prawns, breadedUNSAFE ADDSource
Dynamic Ace Global Sdn BhdSeri Kembangan, MalaysiaCoffee, n.e.cLACKS N/CNCONTACTNUTRIT LBLSource
Dynamic Ace Global Sdn BhdSeri Kembangan, MalaysiaVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNCONTACTNUTRIT LBLSource
The Origin Foods Sdn BhdPuchong, MalaysiaHerbals & botanicals (not teas), n.e.cUNAPPROVEDSource
The Origin Foods Sdn BhdPuchong, MalaysiaHerbals & botanicals (not teas), n.e.cUNAPPROVEDSource
The Origin Foods Sdn BhdPuchong, MalaysiaHerbals & botanicals (not teas), n.e.cUNAPPROVEDSource
Vance Bioenergy Sdn. Bhd.Pasir Gudang, MalaysiaFood additives for human use, n.e.cLIST INGRESource
The Origin Foods Sdn BhdPuchong, MalaysiaGlycine (protein)DIETARYLBLDIETARYINGSource
Dynamic Ace Global Sdn BhdSeri Kembangan, MalaysiaCandy without chocolate n.e.cLACKS N/CNUTRIT LBLSource
Fishergold Cold Storage Sdn BhdBukit Mertajam, MalaysiaPompano (permit, pompanito)VETDRUGRESSource
Oriental Food Industries Sdn BhdMelaka, MalaysiaCake without custard or cream fillingINCONSPICUUSUAL NAMENUTRIT LBLSource
Sen Up Huat Seafood Trading Sdn BhdHutan Melintang, MalaysiaFish, n.e.cFILTHYSource
Sen Up Huat Seafood Trading Sdn BhdHutan Melintang, MalaysiaFish, n.e.cFILTHYSource
Sen Up Huat Seafood Trading Sdn BhdHutan Melintang, MalaysiaFish, n.e.cFILTHYSource
Gold Food Resources Sdn BhdIpoh, MalaysiaVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cINCONSPICUUNAPPROVEDSource
Gold Food Resources Sdn BhdIpoh, MalaysiaVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cINCONSPICUFALSENUTRIT LBL+1Source

Questions about FDA refusals from Malaysia

How many Malaysia shipments did FDA refuse in 2026?
FDA refused 29 shipment lines from Malaysia in 2026 through September 10, 2026, compared with 67 in 2025 (a full year).
Why does FDA refuse food from Malaysia?
FDA records a charge code on every refused shipment line. For Malaysia the most frequent are UNAPPROVED (unapproved new drug, 294 lines), NUTRIT LBL (nutrition information missing from label, 114 lines) and LISTERIA (Listeria monocytogenes, 108 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 Malaysia firms have the most FDA refusals?
In SupplierRadar's records the Malaysia firms with the most FDA records (refusals, import alert listings and other events) are QL FOODS SDN. BHD. (Hutan Melintang) with 108 records, Kingdom Honey SDN. BHD. (Kuala Lumpur) with 89 records and Etumax (Petaling) with 63 records. Each firm's page lists every record with its FDA source.
Which FDA import alerts list Malaysia firms?
As of October 26, 2026, 26 FDA import alerts list at least one firm in Malaysia. The alerts with the most Malaysia listings are Import Alert 16-129 (27 firms), Import Alert 45-02 (24 firms) and Import Alert 54-16 (21 firms).
How many Malaysia firms are on an FDA import alert red list?
As of October 26, 2026, 130 Malaysia firms are on the red list of at least one FDA import alert in SupplierRadar's records, and 130 firms are on any list.

All Malaysia suppliers with FDA records (149)

Every Malaysia 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.