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

Official FDA source ↗Data refreshed 2026-08-27 UTC

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.

  • Argentina · Vitamin, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

  • Brazil · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.

  • Canada · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.

  • 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.

  • 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.

  • China · L-Arginine (Protein); Yohimbe (Herbal & Botanicals, not Teas); Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

  • 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)

  • 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.

  • China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.

  • China · Bee Pollen (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.); Sibutramine HCL Monohydrate (Anorexic); Miscellaneous Patent Medicines, Etc.

  • China · Coffee; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator)

  • China · Herbals & Botanicals (not Teas), N.E.C.; Tadalafil

  • China · Herbals & Botanicals (not Teas), N.E.C.; Tadalafil

  • 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.; Sildenafil Citrate (Regulator); Miscellaneous Patent Medicines, Etc.

  • 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.

  • 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.

  • 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)

  • China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

  • China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Suppressant N.E.C.; Miscellaneous Patent Medicines, Etc.

  • China · Herbals & Botanicals (not Teas), N.E.C.; Anti-Depressant N.E.C.

  • 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.

  • 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)

  • 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)

  • 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)

  • 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.

  • 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

  • Germany · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

  • Germany · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

  • 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.

  • Hong Kong SAR · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator)

  • India · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Cyproheptadine HCl (Anti-Histaminic); A-Histaminic

  • India · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; A-Histaminic; Miscellaneous Patent Medicines, Etc.

  • Jamaica · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Sildenafil Citrate (Regulator); Miscellaneous Patent Medicines, Etc.

  • Korea (The Republic Of) · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

  • Malaysia · Honey; Honey, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.

  • Malaysia · Honey; Honey, N.E.C.; Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

  • 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.

  • Malaysia · Honey; Honey, N.E.C.; Miscellaneous Patent Medicines, Etc.

  • 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

  • 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.

  • Malaysia · Honey; Honey, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

  • 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.

  • Malaysia · Honey; Miscellaneous Patent Medicines, Etc.

  • 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.

  • Malaysia · Honey; Honey, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.

  • Malaysia · Honey; Tadalafil

  • 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

  • Malaysia · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

  • Malaysia · Herbal Coffee (Blend of herbs, grains, fruits and nuts); Coffee/Tea; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)

  • Malaysia · Coffee/Tea; Herbal & Botanicals(other than teas); Sildenafil Citrate (Regulator)

  • 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.

  • 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

  • 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 · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Herbals & Botanical Teas, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.

  • Mexico · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Dietary Conventional Foods, N.E.C.; Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)

  • Mexico · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Dietary Conventional Foods, N.E.C.; Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)

  • 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.

  • Mexico · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • Mexico · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • Taiwan · Herbals & Botanical Teas, N.E.C.

  • Thailand · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sibutramine HCL Monohydrate (Anorexic)

  • 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.

  • 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.

  • 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

  • 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)

  • 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.

  • Vietnam · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Sibutramine HCL Monohydrate (Anorexic); Phenolphthalein (Cathartic)

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