Import Alert 54-16: Detention without physical examination of products that are marketed as foods, including products marketed as dietary supplements, that contain an active pharmaceutical ingredient
FDA last published FDA alert page
As of October 26, 2026, FDA Import Alert 54-16 (Foods/supplements with active pharmaceutical ingredient) lists 98 firms on its red list in 19 countries; 2 firms were added and 0 removed in the last 90 days.
Data from FDA public records, last checked . Request a correction
- 98
- firms on the red list
- 19
- countries
- 2
- added in the last 90 days
- 0
- removed in the last 90 days
What changed in the last 90 days
Additions use the date FDA published each listing. Removals are dated by the day SupplierRadar first saw the firm gone; the weekly and daily checks are described on the data sources page.
Removed from Import Alert 54-16
SupplierRadar has recorded no removals from Import Alert 54-16 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page, and on the firm's own page, the day it is found.
Added to Import Alert 54-16
| Firm | Country | List | Date published |
|---|---|---|---|
| Organics Innovations CompanyMueang Nakhon Pathom, Thailand | Thailand | Red | |
| KukamongaZapopan, Mexico | Mexico | Red |
Firms on Import Alert 54-16, by country
98 listings in 19 countries. Each name links to the firm's FDA record history; the date is the one FDA published on the alert.
Listings by country
China (27)
FDA refusals from China| Firm | List | Products | Date published |
|---|---|---|---|
| Beijing Jianyang Health Product Co., LtdBeijing | Red | Super Shanghai Strong Testis Capsules "Dietary Supplement" | |
| Beijing Kowloon Pharmaceutical FactoryBeijing | Red | 4Everon Sexual Stimulant Tablets (declared as L-Arginine dietary supplement) | |
| Casco Blu QingdaoQingdao | Red | Green Tea/ White Willow Bark Extract | |
| Eagene Biotechnology Co., Ltd.Nanning | Red | Rocket Fuel (Oyster Peptide Tablets) | |
| ELT TechnologyGuangdong | Red | Lose Weight Coffee Slim Delicious | |
| Guangzhou Garden City (Biological) Health Food FactoryGuangzhou | Red | La Jiao Shou Shen | |
| Guangzhou Meilai Biotechnology Co., Ltd.Guangzhou | Red | La Jiao Shou Shen | |
| guangzhou p'productGuangzhou | Red | Herba Plantaginis (Plantain Herb) | |
| Guangzhou Yan Xiang Co, LTDGuangzhou | Red | Ultimate Formula Bee Pollen Capsules | |
| Hengs Jewellry LtdGuangzhou | Red | H.I. Coffee (Herbal Instant Coffee) | |
| Jiangsu Shenhua Pharmaceutical Co., LtdHuaian | Red | Cordyceps extract powder | |
| Jiangsu Shenli Enterprise Co LtdJiangyin City | Red | Cordyceps extract powder | |
| Kunming DaLi Industry & Trade Co., LtdKunming | Red | Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Human and Anim | |
| La Sha City Limited CompanyLa Sha City | Red | France T253 Tablets | |
| Much New LimitedHuangyan | Red | Slim 30 (Natural Herb Supplement for weight loss); Joyful Slim (Puerarin- Chinese Yim Powder) | |
| Net D Active Nutra Trading Co.Ningbo | Red | Blue Steel Dietary Supplement | |
| No. 8 IIAlleyguangdong | Red | Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Human and Anim | |
| Qinghai Baojiantang Pharmaceutical Co., LtdQinghai | Red | Male Sexual Stimulant- U.S.A. Wolf Brother Strong Man | |
| Rizhao Rande TradingShanghai | Red | Fuel Up Plus Pills; Fuel Up High Octane Pills | |
| Sha Double Nutra Biotech ColtdShanghaishanghai | Red | Adrafinil capsules; Anricetam Capsules | |
| Shenzhen BaoyitongShenzhen | Red | Aulijing Zi Su Body Fat Health II Dietary Supplement | |
| Suzhou MyLand Pharm&Nutrition Inc.Suzhou | Red | Propolis Extract Powder | |
| TopLife InternationalChangsha | Red | Meizi Evolution Slimming Softgel | |
| TopLife International (HK)Changsha | Red | Mei Zi Super Power Fruits Capsules | |
| TopLife International Co., Ltd.Changsha | Red | Mei Zi Super Power Fruits Capsules |
Show 2 more firms in China
| Firm | List | Products | Date published |
|---|---|---|---|
| xuancheng baicao plants industry and trade co.,ltdAnhui | Red | Super ArthGold; Pro ArthMax | |
| Zheng Xu BinGuangzhou | Red | Botanical Slimming Gold Version |
Malaysia (21)
FDA refusals from Malaysia| Firm | List | Products | Date published |
|---|---|---|---|
| Achlim Trading Sdn BhdKuala Lumpur | Red | Royal honey vip; kingdom honey for her; kingdom honey for him; kingdom royal honey; etumax royal honey for him | |
| Biotivity SDN BHDBota | Red | Royal Honey VIP | |
| Caverflo Texas TradingSungai Petani | Red | CaverFlo Natural Herbal Coffee | |
| Dose Vital Manufacturing SDN BHDKuala Lumpur | Red | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | |
| Dr Foerster (M) Sdn BhdShah Alam | Red | Dr Foerster Detox Plus Food Supplement; Ultra Detox Capsules | |
| Drs Secret Worldwide Manufacturing Sdn BhdButterworth | Red | Dr's secret bio herbs coffee | |
| Drs Secret Worldwide Manufacturing Sdn BhdSeberang Perai Tengah | Red | DR's SECRET BIO HERBS COFFEE; Mens Bio Honey Malaysia Recipe; Royal King Honey (Food Supplement) | |
| Expo Connect Sdn BhdSeri Kembangan | Red | Helmi's Honey VIP Jantanak Dream (Royal Honey); Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | |
| FikryszSungai Petani | Red | Natural Herbs Coffee | |
| Gold Food Resources Sdn BhdIpoh | Red | Black horse vital honey | |
| Heramios Sdn BhdPetaling Jaya | Red | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | |
| KHAN aLASSALSelangor | Red | Gold Herbs Royal King Honey with Herbal Extracts; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | |
| Kingdom Etumax Bio Sdn BhdPetaling | Red | Kingdom Honey Royal Honey; Etumax Royal Honey | |
| Kingdom Honey SDN. BHD.Kuala Lumpur | Red | KINGDOM ROYAL HONEY; KINGDOM HONEY FOR HER; KINGDOM HONEY FOR HIM; Royal Honey; Vitamins/Minerals (Human/Animal); Protei | |
| Medcare Smart SDN BHDKuala | Red | Golden Royal Honey | |
| Natural ElixirsSelangor | Red | Ultra Detox Capsules; GRANDE PLATINUM - BINDII | |
| Natural Elixirs Sdn BhdPelabuhan Klang | Red | Ultra Detox Capsules | |
| Superfood International Sdn BhdPenang | Red | VITAMAX DOUBLESHOT Energy Honey | |
| Worldgate Vision Beverage Sdn BhdKuala Muda | Red | Kopi Jantan Tradisional Natural Herbs Coffee; Natural Herbs Coffee; STIFF BULL HERBAL COFFEE | |
| Yong Fatt Vision TSungai Petani | Red | Kopi Jantan Tradisional Natural Herbs Coffee | |
| Yongfatt Vision TrSungai Petani | Red | Kopi Jantan Tradisional Natural Herbs Coffee |
Mexico (13)
FDA refusals from Mexico| Firm | List | Products | Date published |
|---|---|---|---|
| Asesoria y Desarrollo de Productos NaturalesGuadalajara | Red | UMARY Acido Hialuronico; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biol | |
| Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan | Red | UMARY Acido Hialuronico; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biol | |
| Eren Naturals SA de CVZapopan | Red | UNAVY Acido Hialuronico Suplemento Alimenticio; UMOVY Acido Hialuronico Suplemento Alimenticio; Pharm Necess & Ctnr For | |
| Especialidades Nutrition SA de CZapopan | Red | UMARY Acido Hialuronico; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biol | |
| Grupo Botanico Nayec SA de CVCiudad De Mexico | Red | Tepezcohuite Capsules | |
| Healthy People Labs S de RL de CVIrapuato | Red | Goji-Man Mangosteen Liquid Dietary Supplement | |
| Healthy People S de R.L. de CVIrapuato | Red | Goji-Man Mangosteen Liquid Dietary Supplement | |
| Herbolaris InternacionalZapopan | Red | CBC Dietary Supplement | |
| KukamongaZapopan | Red | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | |
| Lab NaprovidSonora | Red | Contra Reumas Suplemento Alimenticio (Against Rheumatism Dietary Supplement) | |
| Omega NutritionHidalgo Del Parral | Red | Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Ortiga mas Ajo Rey Extra Forte; Artrifan King; F | |
| Plantas Herbolarias de MexicoSanta Ana | Red | Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (H | |
| Plantas Medicinales de MexicoDELEGACION XOCHIMILCO C.P | Red | Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (H |
Turkey (11)
FDA refusals from Turkey| Firm | List | Products | Date published |
|---|---|---|---|
| Acdc Kozmetik Sanayi Ve Ticaret A.S.Akdeniz | Red | Sensual Honey- Herbal Mixed Paste | |
| Agrosol GidaBornova | Red | Hon e ling 100% all natural libido supplement for men and women (herbal maccun) | |
| Cankatan Food Industry and Trade limited CompanyAnkara | Red | Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium | |
| Cankatan Gida Sanayi Ve TicaretlimIsletim Kayat | Red | Mplus Epimediumlu Bitkisel Macun Herbal Paste With Epimedium | |
| Gokce Bitkisel Urunler-Ufuk GokceKartal | Red | Secret Miracle Honey; Leopard Miracle Honey; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | |
| Han Ithalat Ihracat Ve Danismanlik Ltd StiFevzi Cakmak | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar | |
| Herbalart Gida San Ve Tic LtdIzmit | Red | Stamina By Honey- Honey Mixed Herbal Paste (aka Epimedium Mixed Herbal Paste) | |
| Mubarek Dogal Urunler Gida San Ve Tic Ltd StiYenimahalle | Red | Leopard Miracle of Honey | |
| Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd.Umraniye | Red | All Honey Dietary Supplements | |
| Sekerciler Tic. ve San. Ltd. Sti.Yesilyurt | Red | Honeymoon Herbal Honey; Versace Real Honey for Men; Secret Miracle Honey Extra Strength; Black Panther Miracle Honey for | |
| Veysi TopuzAkdeniz | Red | Epimedium and ginseng herbal supplements; themra epimedium turkish horny goat weed |
Hong Kong (4)
FDA refusals from Hong Kong| Firm | List | Products | Date published |
|---|---|---|---|
| Hong Kong Tianlong Technology International Group CompanyMong Kok | Red | France T253 Tablets | |
| Hongkong Jiuyuejiu Biology Technology CO., LTDUnknown | Red | Bull Tablets | |
| Jin LianBya Kowloon Bay Horngjaan | Red | Black 4K Capsules (Bl4ck 4K)Dietary Supplement | |
| Wuhan 3B Scientific CorporationKowloon Bay, Horngjaan | Red | Vegetal Vigra Capsules |
Colombia (3)
FDA refusals from Colombia| Firm | List | Products | Date published |
|---|---|---|---|
| Almenat SASCali | Red | biQ-FEL | |
| El ManaBogota | Red | Nettle Powder (Ortiga) | |
| Herbal Nutraceutica SasCali | Red | Ultra ZX Capsules |
Vietnam (3)
FDA refusals from Vietnam| Firm | List | Products | Date published |
|---|---|---|---|
| HavycoTp Da Nangtp Da Nang | Red | Vy & Tea | |
| HavycoBu Dang District | Red | Vy & Tea | |
| Mat Xi S.G Co., LtdBien Goa | Red | Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Go lean Detox Capsules |
Canada (2)
FDA refusals from Canada| Firm | List | Products | Date published |
|---|---|---|---|
| Nugale Pharmaceutical Inc.Scarborough | Red | Slimquick Green Coffee Bean Softgel | |
| PNP Pharmaceuticals Inc.Burnaby | Red | U-Dream Lite Herbal Blend |
Germany (2)
FDA refusals from Germany| Firm | List | Products | Date published |
|---|---|---|---|
| Krauter Mix GmbHAbtswind | Red | Dried Bulk Plantain | |
| Paul Muggenburg Gmbh & CoAlveslohe | Red | Dried Bulk Plantain |
India (2)
FDA refusals from India| Firm | List | Products | Date published |
|---|---|---|---|
| Ronak Exim Private Ltd.Vadodara | Red | DR. Ico Cyproheptadine with multi vitamin tablets; DR. ICO Cyproheptadine with Multivitamin Tablets | |
| Zahidi Pharmaceutical Pvt LtdGujarat | Red | Zahidi vita Plus |
Thailand (2)
FDA refusals from Thailand| Firm | List | Products | Date published |
|---|---|---|---|
| H.C. Herb Club LaboratoryPathumthani | Red | PAYA Dietary Supplement Product | |
| Organics Innovations CompanyMueang Nakhon Pathom | Red | ZUBB Dietary Supplement Product (Dr. JEL Brand) |
Argentina (1)
FDA refusals from Argentina| Firm | List | Products | Date published |
|---|---|---|---|
| Molecular Dynamics SASBuenos Aires | Red | XHUM Monarch Sexual Enrichment Supplement |
Brazil (1)
FDA refusals from Brazil| Firm | List | Products | Date published |
|---|---|---|---|
| Michelle GleneuineRio de Janeiro | Red | PEB One and PEB Two Capsules (Brand Renutryent) Dietary Supplement |
Ecuador (1)
FDA refusals from Ecuador| Firm | List | Products | Date published |
|---|---|---|---|
| ZaphiredelcorQuito | Red | Mero Macho Liquid Supplement |
Ghana (1)
FDA refusals from Ghana| Firm | List | Products | Date published |
|---|---|---|---|
| Geo Medicore LimitedAccra | Red | GML-APETI Multivitamin tablets; Gml apeti |
Jamaica (1)
FDA refusals from Jamaica| Firm | List | Products | Date published |
|---|---|---|---|
| Daromale International TradingKingston | Red | Black Stallion Bedroom Tonic |
South Korea (1)
FDA refusals from South Korea| Firm | List | Products | Date published |
|---|---|---|---|
| Dae Han CorporationSeongnam-si | Red | Power Khan Pills |
Taiwan (1)
FDA refusals from Taiwan| Firm | List | Products | Date published |
|---|---|---|---|
| Sun Ten Pharmaceutical Co., Ltd.New Taipei City Taipei - Special Municip | Red | Red Yeast Rice |
Ukraine (1)
FDA refusals from Ukraine| Firm | List | Products | Date published |
|---|---|---|---|
| Farmakom LtdKharkiv | Red | Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Male Potency-F |
Refusal charges named on this alert
FDA's alert page names these charge codes. The counts are refusal lines FDA recorded under each charge since October 2016, for all firms, not only firms on this alert.
| Charge code | Meaning | Refusal lines since 2016 |
|---|---|---|
| UNAPPROVED | Unapproved new drug | 5,203 |
| POISONOUS | Poisonous or deleterious substance | 2,420 |
| UNSAFE ADD | Food additive unsafe under section 409 | 2,275 |
| DIRECTIONS | Is a device whose label appears to not bear adequate directions for use. | 297 |
What the alert covers and why FDA issued it
FDA's wording, with FDA's change markers removed.
- Official title
- DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT
- Product scope
- PRODUCTS: Dietary Supplements Unapproved New Drugs Misbranded Drugs PRODUCT CODE: "See Red List" PROBLEM: Unapproved New Drugs; Misbranded Drugs, Unapproved Food Additive; Adulterated Food
- Last published
FDA field investigations and laboratory analyses have concluded that a number of imported products marketed as dietary supplements that are often promoted for sexual enhancement, weight loss, muscle building, lifestyle, and other claims, contain undeclared active pharmaceutical ingredients (APIs).
FDA investigations find the APIs include: anticoagulants (e.g., Warfarin) anticonvulsants (e.g., Phenytoin) HMG-CoA reductase inhibitors (e.g., Lovastatin), Phosphodiesterase type 5 inhibitors (e.g., Sildenafil) prescription nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., Indomethacin) beta-blockers (e.g., Propranolol) controlled substances (Benzodiazepines and anabolic steroids) APIs removed from the market for reasons of safety or efficacy (e.g., Sibutramine) novel synthetic steroids, and new chemicals ingredients of unknown safety and efficacy.
Read the rest of the reason
These APIs, because of their toxicity or other potential for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under the supervision of a practitioner licensed by law to administer such products.
FDA analyses and investigations revealed that these products frequently contain the same APIs, or analogues of APIs, that are in FDA-approved drugs. Depending on the circumstances, these products are misbranded and unapproved new drugs, or adulterated food under the Federal Food, Drug, and Cosmetic Act. Note: Charge statement revised on 04/23/2019.
Listing on an import alert is FDA's notice to the firm and a fact an importer must consider in its supplier evaluation under 21 CFR 1.505. What the red, green and yellow lists mean.
Questions about Import Alert 54-16
- What is Import Alert 54-16?
- Import Alert 54-16, “Detention without physical examination of products that are marketed as foods, including products marketed as dietary supplements, that contain an active pharmaceutical ingredient”, is an FDA import alert. FDA may detain products from the firms on its red list without physical examination; FDA last published the alert on October 15, 2026.
- Which firms are on Import Alert 54-16?
- As of October 26, 2026, 98 firms are listed on Import Alert 54-16 in 19 countries; the most listings are in China (27), Malaysia (21) and Mexico (13). The full table, grouped by country, is below on this page and every firm links to its record.
- How do firms get off Import Alert 54-16?
- A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 54-16; our guide explains the steps and the evidence FDA usually asks for.
- What charge does FDA use under Import Alert 54-16?
- The charge section of Import Alert 54-16 names UNAPPROVED (unapproved new drug), POISONOUS (poisonous or deleterious substance), UNSAFE ADD (food additive unsafe under section 409) and DIRECTIONS (is a device whose label appears to not bear adequate directions for use.). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.
- Which firms were added to Import Alert 54-16 recently?
- As of October 26, 2026, 2 firms were added to Import Alert 54-16 in the last 90 days, including Organics Innovations Company and Kukamonga. The list with dates is below.
- Which firms were removed from Import Alert 54-16 recently?
- SupplierRadar has recorded no removals from Import Alert 54-16 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page and on the firm's page the day it is found.
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