FDA import alert
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
100
Red-list entries
0
Green-list entries
19
Countries
2026-08-14
Last change seen
What being on this list means
Firms on an import alert's Red List are subject to Detention Without Physical Examination (DWPE): FDA can detain their shipments at the border automatically, without sampling or inspecting them. The burden shifts to the importer to prove — typically with private laboratory analysis, shipment by shipment — that the goods are not violative. Removal from the list requires evidence that the underlying problem is resolved, usually including a track record of consecutive clean shipments and a petition to FDA. How removal works →
A Green List on a countrywide alert works the other way: it names the firms FDA has excluded from detention because they demonstrated compliance.
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Red-list entries by country
Firms on this red list
Showing 100 of 100 entries — search a specific firm on the free checker.
- MOLECULAR DYNAMICS SAS
03/12/2024
Argentina · Vitamin, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Michelle Gleneuine
05/11/2015
Brazil · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Nugale Pharmaceutical Inc.
04/14/2015
Canada · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
- PNP Pharmaceuticals Inc.
05/26/2020
Canada · Vitamin, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- BEIJING JIANYANG HEALTH PRODUCT CO., LTD
05/07/2015
China · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Beijing Kowloon Pharmaceutical Factory
06/29/2015
China · L-Arginine (Protein); Yohimbe (Herbal & Botanicals, not Teas); Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Casco Blu Qingdao
09/28/2016
China · Tea, Green; Willowbark (Herbal & Botanicals, not Teas); Herbals & Botanicals (not Teas), N.E.C.
- ELT Technology
04/17/2015
China · Coffee/Tea; Sibutramine HCL Monohydrate (Anorexic)
- Eagene Biotechnology Co., Ltd.
05/12/2015
China · Animal By-Products and Extracts, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Tadalafil
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Guangzhou Meilai Biotechnology Co., Ltd.
04/23/2015
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Guangzhou Yan Xiang Co, LTD
05/19/2015
China · Bee Pollen (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.); Sibutramine HCL Monohydrate (Anorexic); Miscellaneous Patent Medicines, Etc.
- HENGS JEWELLRY LTD
02/15/2018
China · Coffee; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator)
- Jiangsu Shenhua Pharmaceutical Co., Ltd
09/22/2023
China · Herbals & Botanicals (not Teas), N.E.C.; Tadalafil
- Jiangsu Shenli Enterprise Co Ltd
09/22/2023
China · Herbals & Botanicals (not Teas), N.E.C.; Tadalafil
- Kunming DaLi Industry & Trade Co., Ltd
04/01/2015
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs
- La Sha City Limited Company
05/15/2015
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator); Miscellaneous Patent Medicines, Etc.
- Much New Limited
07/07/2015
China · Hawthorn (Herbal & Botanicals, not Teas); Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- NET D ACTIVE NUTRA TRADING CO.
06/22/2015
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
- No. 8 IIAlley
05/04/2015
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.; Exhibits - Other Drug Related Items N.E.C.
- Rizhao Rande Trading
08/01/2016
China · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator)
- Sha Double Nutra Biotech Coltd
05/23/2016
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Shenzhen Baoyitong
10/26/2016
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Suppressant N.E.C.; Miscellaneous Patent Medicines, Etc.
- Suzhou MyLand Pharm&Nutrition Inc.
11/09/2015
China · Herbals & Botanicals (not Teas), N.E.C.; Anti-Depressant N.E.C.
- TopLife International
10/04/2016
China · Herbals & Botanical Teas, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- TopLife International (HK)
03/02/2017
China · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sibutramine HCL Monohydrate (Anorexic)
- TopLife International (HK)
09/12/2016
China · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sibutramine HCL Monohydrate (Anorexic)
- TopLife International Co., Ltd.
09/12/2016
China · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sibutramine HCL Monohydrate (Anorexic)
- Zheng Xu Bin
11/10/2016
China · Herbals & Botanical Teas, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sibutramine HCL Monohydrate (Anorexic)
- guangzhou p'product
04/03/2023
China · Herbals & Botanical Teas, N.E.C.
China · Herbal and Botanical
- ALMENAT SAS
07/09/2026
Colombia · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Sildenafil Citrate (Regulator); Miscellaneous Patent Medicines, Etc.
- El Mana
12/10/2021
Colombia · Herbals & Botanicals (not Teas), N.E.C.
- Herbal Nutraceutica Sas
09/25/2015
Colombia · Herbals & Botanicals (not Teas), N.E.C.; Sibutramine HCL Monohydrate (Anorexic); Miscellaneous Patent Medicines, Etc.
- ZAPHIREDELCOR
09/04/2019
Ecuador · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Tadalafil
- Zaphiredelcor
09/04/2019
Ecuador · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Tadalafil
- Krauter Mix GmbH
04/03/2023
Germany · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Paul Muggenburg Gmbh & Co
04/03/2023
Germany · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Geo Medicore Limited
08/07/2025
Ghana · Vitamin B1 (Thiamine); Vitamin B2 (Riboflavin); Vitamin B6 (Pyridoxine)
Hong Kong SAR · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator); Miscellaneous Patent Medicines, Etc.
Hong Kong SAR · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator); Tadalafil
- Jin Lian
01/25/2017
Hong Kong SAR · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator); Miscellaneous Patent Medicines, Etc.
- Wuhan 3B Scientific Corporation
07/17/2017
Hong Kong SAR · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator)
- Ronak Exim Private Ltd.
09/18/2025
India · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Cyproheptadine HCl (Anti-Histaminic); A-Histaminic
- ZAHIDI PHARMACEUTICAL PVT LTD
10/03/2025
India · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; A-Histaminic; Miscellaneous Patent Medicines, Etc.
- Daromale International Trading
10/26/2020
Jamaica · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Sildenafil Citrate (Regulator); Miscellaneous Patent Medicines, Etc.
- Dae Han Corporation
06/30/2015
Korea (The Republic Of) · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Achlim Trading Sdn Bhd
09/07/2016
Malaysia · Honey; Honey, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.
- Biotivity SDN BHD
06/29/2017
Malaysia · Honey; Honey, N.E.C.; Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
- CAVERFLO TEXAS TRADING
09/26/2017
Malaysia · Coffee; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator)
Malaysia · Coffee; Honey; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Dose Vital Manufacturing SDN BHD
06/08/2018
Malaysia · Honey; Honey, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Dr Foerster (M) Sdn Bhd
11/27/2018
Malaysia · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Malaysia · Coffee; Tadalafil
- EXPO CONNECT SDN BHD
06/26/2019
Malaysia · Food Sweeteners/Nutritive syrups/honey/molasses; Vit/Min/Prot/Unconv Diet Spec N.E.C.; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
- Fikrysz
04/14/2023
Malaysia · Exhibits - Other Drug Related Items N.E.C.
- GOLD FOOD RESOURCES SDN BHD
03/17/2023
Malaysia · Honey; Honey, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- HERAMIOS SDN BHD
06/08/2018
Malaysia · Honey; Honey, N.E.C.; Miscellaneous Patent Medicines, Etc.
- KHAN aLASSAL
05/10/2019
Malaysia · Honey; Honey, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.
- KINGDOM ETUMAX BIO SDN BHD
05/02/2023
Malaysia · Honey; Miscellaneous Patent Medicines, Etc.
- KINGDOM HONEY SDN BHD
07/10/2017
Malaysia · Honey; Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.); Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Kingdom Honey SDN. BHD.
03/26/2019
Malaysia · Honey; Honey, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.
- Medcare Smart SDN BHD
09/22/2016
Malaysia · Honey; Tadalafil
- NATURAL ELIXIRS SDN BHD
11/27/2018
Malaysia · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Tadalafil; Miscellaneous Patent Medicines, Etc.
- Natural Elixirs
05/04/2017
Malaysia · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Tadalafil
- SUPERFOOD INTERNATIONAL SDN BHD
01/31/2022
Malaysia · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Worldgate Vision Beverage Sdn Bhd
08/05/2016
Malaysia · Herbal Coffee (Blend of herbs, grains, fruits and nuts); Coffee/Tea; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
- Yong Fatt Vision T
09/19/2017
Malaysia · Coffee/Tea; Herbal & Botanicals(other than teas); Sildenafil Citrate (Regulator)
- Yongfatt Vision Tr
09/19/2017
Malaysia · Coffee/Tea; Herbal & Botanicals(other than teas); Sildenafil Citrate (Regulator)
Mexico · Dietary Conventional Foods, N.E.C.; Food Additives For Human Use, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Mexico · Dietary Conventional Foods, N.E.C.; Food Additives For Human Use, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- EREN NATURALS SA DE CV
06/17/2025
Mexico · Glucosamine Hydrochloride (Herbal and Botanicals, not Teas II); Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Pharm Necess & Ctnr For Drug/Bio
- ESPECIALIDADES NUTRITION SA DE C
07/29/2024
Mexico · Dietary Conventional Foods, N.E.C.; Food Additives For Human Use, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- GRUPO BOTANICO NAYEC SA DE CV
02/04/2016
Mexico · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Herbals & Botanical Teas, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.
- Healthy People Labs S de RL de CV
01/25/2018
Mexico · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Dietary Conventional Foods, N.E.C.; Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
- Healthy People S de R.L. de CV
01/25/2018
Mexico · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Dietary Conventional Foods, N.E.C.; Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
- Herbolaris Internacional
01/24/2018
Mexico · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Dietary Conventional Foods, N.E.C.; Herbals & Botanical Teas, N.E.C.
- KUKAMONGA
08/14/2026
Mexico · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
- LAB NAPROVID
06/22/2026
Mexico · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Dietary Conventional Foods, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.
- OMEGA NUTRITION
07/11/2022
Mexico · Vitamin, N.E.C.; Glucosamine Hydrochloride (Herbal and Botanicals, not Teas II); Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- PLANTAS HERBOLARIAS DE MEXICO
07/07/2023
Mexico · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
- PLANTAS MEDICINALES DE MEXICO
06/08/2022
Mexico · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
- SUN TEN PHARMACEUTICAL CO., LTD.
02/17/2016
Taiwan · Herbals & Botanical Teas, N.E.C.
- H.C. Herb Club Laboratory
08/02/2018
Thailand · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sibutramine HCL Monohydrate (Anorexic)
- ACDC KOZMETIK SANAYI VE TICARET A.S.
03/26/2019
Turkey · Honey; Honey, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.
- AGROSOL GIDA
11/05/2024
Turkey · Tea, N.E.C.; Herbals & Botanical Teas, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- CANKATAN GIDA SANAYI VE TICARETLIM
04/14/2023
Turkey · Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.); Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Turkey · Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.); Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- GOKCE BITKISEL URUNLER-UFUK GOKCE
01/16/2019
Turkey · Honey; Honey, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.
Turkey · Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products
- HERBALART GIDA SAN VE TIC LTD
12/11/2020
Turkey · Taffy (Toffee), Kisses Candy, Soft, with Nuts and Fruit (without Chocolate); Honey; Honey, N.E.C.
Turkey · Honey; Herbal & Botanicals(other than teas)
Turkey · Food Sweeteners/Nutritive syrups/honey/molasses; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Sildenafil Citrate (Regulator)
- Sekerciler Tic. ve San. Ltd. Sti.
09/28/2022
Turkey · Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate); Honey; Honey, N.E.C.
- Veysi Topuz
08/06/2021
Turkey · Ginseng Unconventional Dietary Speciality for Humans or Animals; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Farmakom Ltd
08/11/2020
Ukraine · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Miscellaneous Patent Medicines, Etc.
- HAVYCO
09/14/2021
Vietnam · Herbals & Botanical Teas, N.E.C.; Sibutramine HCL Monohydrate (Anorexic); Miscellaneous Patent Medicines, Etc.
- Havyco
09/14/2021
Vietnam · Herbals & Botanical Teas, N.E.C.; Sibutramine HCL Monohydrate (Anorexic); Miscellaneous Patent Medicines, Etc.
- MAT XI S.G CO., LTD
05/14/2019
Vietnam · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Sibutramine HCL Monohydrate (Anorexic); Phenolphthalein (Cathartic)
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