FDA import alert
Import Alert 66-41
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
1,925
Red-list entries
0
Green-list entries
107
Countries
2026-10-09
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
| Country | Entries |
|---|---|
| India | 285 |
| Canada | 243 |
| China | 236 |
| Mexico | 99 |
| Korea (The Republic Of) | 95 |
| United Kingdom | 69 |
| Hong Kong SAR | 50 |
| Thailand | 44 |
| Nigeria | 41 |
| Philippines | 41 |
| Malaysia | 35 |
| Germany | 32 |
| Italy | 32 |
| Pakistan | 32 |
| South Africa | 30 |
| France | 28 |
| United States | 26 |
| Switzerland | 25 |
| Australia | 24 |
| Netherlands | 23 |
| Spain | 22 |
| Taiwan | 22 |
| Indonesia | 21 |
| Ghana | 19 |
| Israel | 19 |
+ 82 more countries
Firms on this red list
Showing 100 of 1,925 entries — search a specific firm on the free checker.
- Guillermo Rivera
09/30/2009
Argentina · Isotretinoin (Keratolytic)
- OP Online-Pharmacy.cc
09/30/2009
Argentina · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- UNILEVER DE ARGENTINA SA
01/06/2011
Argentina · Perfumes (Fragrance Preparations); Other Fragrance Preparations, N.E.C.; Astringent/Anti-Perspirant N.E.C.
- ARSSI ALLIANCE LLC
08/11/2023
Armenia · Other Skin Care Preparations, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
- AUSTRALIAN HEALTH INDUSTRY CO.
09/29/2020
Australia · Moisturizing (Skin Care Preparations); Paste Masks (Mud Packs) (Skin Care Preparations); Other Skin Care Preparations, N.E.C.
- Alphapharm
11/07/2011
Australia · Cyproterone Acetate (Anti-Androgen)
- AtheroCare
03/17/2025
Australia · Miscellaneous Patent Medicines, Etc.; Exhibits - Other Drug Related Items N.E.C.
- BIO HEALTH PHARMACEUTICALS
09/28/2012
Australia · 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.
- Brands Rmj P L
12/10/2009
Australia · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- CONCORD INTERNATIONAL TRADING PTY LTD
09/28/2012
Australia · 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.
- Cat Media Pty Limited
04/03/2013
Australia · Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations); Miscellaneous Patent Medicines, Etc.
- Cholrem Pty Ltd
03/17/2025
Australia · Miscellaneous Patent Medicines, Etc.; Exhibits - Other Drug Related Items N.E.C.
- E-pharmacy.net
09/30/2009
Australia · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- Homart Pharmaceuticals Pty. Ltd.
07/26/2024
Australia · Vit/Min/Prot/Unconv Diet Spec N.E.C.; Miscellaneous Patent Medicines, Etc.
- Liberty Lifestyle Pty LTd.
09/30/2009
Australia · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- Melcare Biomedical Pty
03/24/2015
Australia · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Miscellaneous Antibiotics, N.E.C.
- Milk And Co Pty Ltd
12/15/2015
Australia · Baby Prod; Skin Care Prep; Suntan Preparations
- Natural Vitality
06/09/2017
Australia · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Nutricia Australia
01/06/2016
Australia · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Pro-Ma Systems (Aust.) Pty. Ltd.
01/07/2014
Australia · Foundations (Makeup Preparations, not for Eyes); Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations); Wrinkle Smoothing (Skin Care Preparations)
- SUPERCHARGE FOOD PTY LTD
03/22/2021
Australia · Flours and Meals N.E.C.; Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Sensuous
10/01/2015
Australia · Analgesic, N.E.C.; Miscellaneous Patent Medicines, Etc.
- The Dispensary
09/30/2009
Australia · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- Ultra Mix (Aust) Pty Ltd
05/19/2016
Australia · Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations); Other Skin Care Preparations, N.E.C.; Vitamin, N.E.C.
- Valu Pharmaceuticals.com
09/30/2009
Australia · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- WallCann IP Pty Ltd
09/30/2009
Australia · A-Neoplastic; Keratolytic; Salicylic Acid (Keratolytic)
- Wallace Service P/L Clive Wallace
09/30/2009
Australia · Sildenafil Citrate (Regulator)
- i-pharmacy
09/30/2009
Australia · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- Nowicky Pharma
03/16/2022
Austria · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- SKYLINE HANDELS GMBH
08/01/2019
Austria · Cosmetics; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Human and Animal Drugs
- AZSAFFRON MMC
04/14/2026
Azerbaijan · Saffron, Whole (Spice); Miscellaneous Patent Medicines, Etc.
- AZZEFERAN-AZSAFFRON MMC
04/14/2026
Azerbaijan · Saffron, Whole (Spice); Miscellaneous Patent Medicines, Etc.
- ASAP Service Limited
06/27/2018
Bahamas · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Lenex Labs
09/30/2009
Bahamas · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- NEW LIFE NATURAL VEGETATION CELL
08/25/2017
Bahamas · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Antifungal N.E.C.
- Planet Systems, Inc.
09/30/2009
Bahamas · Isotretinoin (Keratolytic)
- ACI FOODS LTD
04/12/2018
Bangladesh · Chlorhexidine Gluconate; Chlorcyclizine HCl (Anti-Histaminic)
- Aci
04/12/2018
Bangladesh · Chlorhexidine Gluconate; Chlorcyclizine HCl (Anti-Histaminic)
- Kohinoor Chemical Co.(Bd)Ltd
04/18/2016
Bangladesh · Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
- PRAN AGRO LTD
03/02/2018
Bangladesh · Fried Snack Foods, N.E.C.; Snack Foods Not Elsewhere Mentioned, N.E.C.; Miscellaneous Patent Medicines, Etc.
- PRAN Agro Ltd.
03/02/2018
Bangladesh · Fried Snack Foods, N.E.C.; Snack Foods Not Elsewhere Mentioned, N.E.C.; Miscellaneous Patent Medicines, Etc.
- SPICY AGRO PRODUCTS LTD.
04/12/2018
Bangladesh · Chlorhexidine Gluconate; Chlorcyclizine HCl (Anti-Histaminic)
- Sufia Chemical Industry
12/02/2016
Bangladesh · Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products); Miscellaneous Patent Medicines, Etc.
- GLOBAL DRUG SUPPLY
09/01/2016
Barbados · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Laboratoires Ndv
02/23/2012
Belgium · Other Skin Care Preparations, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Link2biz Nv
03/07/2011
Belgium · Miscellaneous Patent Medicines, Etc.
- Generic Viagra. Bz
09/30/2009
Belize · Sildenafil Citrate (Regulator)
- Meds India, Ltd.
09/30/2009
Belize · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Zellyn Cell Research
09/30/2009
Bermuda · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
Brazil · Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations); Other Manicuring Preparations, N.E.C.; Foot Powders and Sprays (Skin Care Preparations)
- Fitoterapicos A Cura
09/30/2009
Brazil · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs
- PHYTOTHERM SIM
09/30/2009
Brazil · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Pineda Laboratorio
04/23/2020
Brazil · Cosmetics; Botox; Myobloc
- Zipmed Mesoone
09/08/2010
Brazil · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Canadian Pharmacy
09/30/2009
British Virgin Islands · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- Hormone Boutique
09/30/2009
British Virgin Islands · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Doych
06/28/2021
Bulgaria · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- LES LABORATOIRES B&B
08/23/2023
Cameroon · Cosmetics; Miscellaneous Patent Medicines, Etc.
- Tip Top Beauty Supply
06/28/2013
Cameroon · Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness); Moisturizing (Skin Care Preparations); Miscellaneous Patent Medicines, Etc.
- 1217215 Alberta Ltd.
05/21/2012
Canada · Flavored Candy, Hard (Live Savers, Etc.), with Nuts or Nut Products (not Coconut or Suckers)(without; Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate); Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
- 1217215 Alberta Ltd.
05/21/2012
Canada · Flavored Candy, Hard (Live Savers, Etc.), with Nuts or Nut Products (not Coconut or Suckers)(without; Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate); Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
- 1965599 ONTARIO LTD
01/17/2025
Canada · 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.
- 1965599 ONTARIO LTD.
01/17/2025
Canada · 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.
- 2156619 Ontario Inc
11/08/2011
Canada · Petrolatum (Pharmaceutic Necessity - Ointment Base); Lanolin (Pharmaceutic Necessity - Water in Oil Emulsion); Sodium Formaldehyde Sulfoxylate (Pharmaceutic Necessity - Preservative)
- 2187954 ALBERTA INC
11/08/2023
Canada · Perfumes (Fragrance Preparations); Ammonium Chloride (Acidifier); Ammonia Spirit, Arommatic (Stimulant)
- 2187954 ALBERTA INC
11/08/2023
Canada · Perfumes (Fragrance Preparations); Ammonium Chloride (Acidifier); Ammonia Spirit, Arommatic (Stimulant)
- 2187954 ALBERTA INC.
11/08/2023
Canada · Perfumes (Fragrance Preparations); Ammonium Chloride (Acidifier); Ammonia Spirit, Arommatic (Stimulant)
- 2201371 Ontario Inc.
09/01/2015
Canada · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Miscellaneous Patent Medicines, Etc.
- 2201371 Ontario Inc.
09/01/2015
Canada · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Miscellaneous Patent Medicines, Etc.
- 381922 Ontario Ltd.
09/30/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- 7338457 Canada Inc
06/14/2013
Canada · Herbals & Botanicals (not Teas), N.E.C.
- 7338457 Canada Inc
06/14/2013
Canada · Herbals & Botanicals (not Teas), N.E.C.
- 7338457 Canada Inc
06/14/2013
Canada · Herbals & Botanicals (not Teas), N.E.C.
- 77Canadapharmacy.com
09/30/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- 8046255 Canada Inc.
06/15/2020
Canada · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Abas Pharmacy
09/30/2009
Canada · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- Abbott Renuka Pharmacy Ltd.
09/30/2009
Canada · Isotretinoin (Keratolytic)
- Absorb Science Inc
12/02/2015
Canada · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- Acenzia Inc.
08/15/2022
Canada · Iodine (Mineral); Bee Pollen (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.
- Adv Care Pharmacy Inc.
09/30/2009
Canada · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- Advanced Orthomolecular Research Inc
05/07/2014
Canada · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Akc Nutraceuticals Inc.
11/13/2012
Canada · Moisturizing (Skin Care Preparations); Other Skin Care Preparations, N.E.C.
- Altesse Cosmetique Inc
09/30/2009
Canada · Miscellaneous Patent Medicines, Etc.
- Americana Meds
09/30/2009
Canada · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- Aptecha Inc
09/13/2019
Canada · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- Arborg Pharmacy
09/30/2009
Canada · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- Attogram Corp.
09/17/2019
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Avaria Health & Beauty Corp
02/09/2016
Canada · Other Oral Hygiene Products, without Fluoride, N.E.C.; Miscellaneous Patent Medicines, Etc.
- BIOCEAN CANADA
06/28/2013
Canada · Skin Care Preparations, Cosmetic products containing animal by-products (other animal by-products); Mineral N.E.C.; Omega-3 (Fats and Lipid Substances)
- Babyboomer-Reboot
10/09/2012
Canada · Herbals & Botanicals (not Teas), N.E.C.; Miscellaneous Patent Medicines, Etc.
- Bell Lifestyle Products Inc.
03/06/2023
Canada · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Miscellaneous Patent Medicines, Etc.
- Biomedica Labs
09/30/2009
Canada · Herbals & Botanicals (not Teas), N.E.C., Hum Fd Dietary Suppl Multi Ingr, NonSterile Powder
- Bioxem Inc.
09/30/2009
Canada · Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
- Black Mountain IDA Pharmacy (1979) Ltd.
09/30/2009
Canada · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
- Botanikur Inc.
09/08/2020
Canada · Mineral; Herbal and Botanical; Herbal & Botanicals(other than teas)
- Brasserie Maltco Inc.
12/12/2023
Canada · Soft Drink, Imitation Fruit Flavored, Carbonated; Soda Water, Carbonated; Carbonated Soft Drink, N.E.C.
- Bryson Garden Remedies
09/30/2009
Canada · Herbals & Botanicals (not Teas), N.E.C.
- CANLAB RESEARCH
03/21/2020
Canada · Peptide N.E.C.
- CANUSA Health Group
09/13/2019
Canada · Anterior Pituitary Suppressor N.E.C.; Somatropin (Hormone); Isotretinoin (Keratolytic)
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
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