FDA import alert
Import Alert 66-41
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
1,916
Red-list entries
0
Green-list entries
107
Countries
2026-06-23
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.
Red-list entries by country
| Country | Entries |
|---|---|
| India | 283 |
| Canada | 242 |
| China | 234 |
| Mexico | 99 |
| Korea (The Republic Of) | 94 |
| United Kingdom | 69 |
| Hong Kong SAR | 49 |
| 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 30 of 1,916 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; Salicylic Acid (Keratolytic); 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
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