FDA import alert
Import Alert 66-57
Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S.
161
Red-list entries
0
Green-list entries
37
Countries
2026-03-23
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.
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Red-list entries by country
+ 12 more countries
Firms on this red list
Showing 100 of 161 entries — search a specific firm on the free checker.
Antigua & Barbuda · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Biomedical Holding AVV
09/10/2009
Aruba · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Crowded Planet c/o Richard Hughes
09/10/2009
Australia · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- DurusPharma
09/10/2009
Bahamas · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
Bahamas · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Juan Martinez Minitraders
09/10/2009
Bahamas · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
Bahamas · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Bahamas · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Minitraders (Mr. Juan Martinez)
09/10/2009
Bahamas · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Northam Medication Service
09/10/2009
Bahamas · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Universal Trading
09/10/2009
Bahamas · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- E Claes
09/10/2009
Belgium · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- M Bourquin
09/10/2009
Belgium · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Margaret Eden
09/10/2009
Belgium · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- N Clan
09/10/2009
Belgium · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- S Kessler
09/10/2009
Belgium · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Zita Tros
09/10/2009
Belgium · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- EFES Corporation
09/10/2009
British Virgin Islands · Human and Animal Drugs
- BEDESSEE IMPORTS LTD
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Brash, Dolores
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Canada Drugs
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Canada Rx Pharmacy
03/14/2017
Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- De La Web Multimedia Exposicion, Inc.
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- ELIE PHARMACY
04/14/2025
Canada · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
- Hunters Pharmacy
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- MEDIPLAN PHARMACY
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Mediplan Healthcare Consulting
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- NorthWestPharmacy.com
03/14/2017
Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Optimum Compounding Pharmacy
09/10/2009
Canada · Sildenafil Citrate (Regulator); Stimulant N.E.C.
- PARKWAY PHARMACY
01/31/2025
Canada · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
- Point Douglas Pharmacy
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- PrescriptionPoint
03/14/2017
Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- RX North.Com
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Rx.North.com
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- RxNorth.com
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Sameday (Canada Drugs)
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Sameday (Day And Ross)
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Serono Canada
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Target Zone Training
09/10/2009
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Anhui Anke Biotechnology Co., Ltd.
09/10/2009
China · Human Growth Hormone (Hormone)
- Bao Shan Pharaceutical Factory
09/10/2009
China · Fenfluramine HCl (Anorexic)
China · Human Growth Hormone (Hormone), Human - Rx/Single Ingredient, Small Volume Parenteral <100ml
China · Human Growth Hormone (Hormone)
China · Human Growth Hormone (Hormone); Somatropin (Hormone)
- Shanghi Shang-Amer Trading Co., Ltd
09/10/2009
China · Human Growth Hormone (Hormone); Somatropin (Hormone)
- Biomedical Holding AVV
09/10/2009
Curacao · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Curacao Services N V
09/10/2009
Curacao · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Elina Pharmaceuticals (aka viagraep.com)
09/10/2009
Cyprus · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Viagraep (aka Elina Pharmaceuticals)
09/10/2009
Cyprus · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- A. Werner & Co.
09/10/2009
Czech Republic · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Lifestyle Pharmacy
09/10/2009
Dominica · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Pharmacie Chatel
09/10/2009
France · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- International Products
09/10/2009
Germany · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Quotaz S A
09/10/2009
Germany · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Schneider, Juergen
09/10/2009
Germany · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
Gibraltar · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
Gibraltar · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Longevity Products, Ltd.
09/10/2009
Gibraltar · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- B Mougios and Co
09/10/2009
Greece · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Cybermedrx (aka John W.)
09/10/2009
Greece · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Cybermedrx (aka John W.)
09/10/2009
Greece · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Medicall (Max Schmidt)
09/10/2009
Greece · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Olympia Skouvara
09/10/2009
Greece · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
Greece · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Joui Limited
09/10/2009
Hong Kong SAR · Tadalafil
- Libertarian Solutions
09/10/2009
Hong Kong SAR · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Ajanta Pharma Limited
09/10/2009
India · Sildenafil Citrate (Regulator), Human - Rx/Combination Ingredient
- Cipla Limited
09/10/2009
India · Antibiotics (Human/Animal); Human and Animal Drugs
- Dr. B.A. Prasanna
09/10/2009
India · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- IASO Pharmaceuticals Private Limited
06/08/2017
India · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
India · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Makhmalchi, Hamid Reza
09/10/2009
India · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Meridan Marketing Services
09/10/2009
India · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- One World Pharma Pvt. Ltd.
09/10/2009
India · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Shah & Shah Intraocular Lens (Pvt) Ltd
09/10/2009
India · Hydroxypropyl Methylcellulose (Pharmaceutic Necessity - Suspending Agent)
- Unicure Remedies Pvt. Ltd.
09/10/2009
India · Tadalafil
- Vinay Medical Stores
09/10/2009
India · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Wicks Pharmaceuticals Pvt Ltd
09/10/2009
India · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Indonesia · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
Indonesia · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- USA Medicine.com Ltd. (Mr. Mark Caron)
09/10/2009
Ireland · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Israel Pharmacy Ltd
04/18/2016
Israel · Herbals & Botanicals (not Teas), N.E.C.; Naltrexone Hydrochloride (Analgesic, Narcotic); Naltrexone (Antagonist)
- Magic of Nature c/o Olga Buchman
09/10/2009
Israel · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Nezah Israel Pharmacy
04/18/2016
Israel · Herbals & Botanicals (not Teas), N.E.C.; Naltrexone Hydrochloride (Analgesic, Narcotic); Naltrexone (Antagonist)
- Anagen (aka DMC di Vezzi Roberto)
09/10/2009
Italy · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- DMC di Vezzi Roberto (aka anagen.net)
09/10/2009
Italy · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Farmacia Cerati di Zambonardi Aldo
09/10/2009
Italy · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Quotaz S. A.
09/10/2009
Italy · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- SamjinPharm
09/10/2009
Korea (The Republic Of) · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Pharmacy International, Inc.
09/10/2009
Malaysia · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Azteca Trio International S A De C V
09/10/2009
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Baja Triado Internacional S A de C V
09/10/2009
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- CORNE S A de C V
09/10/2009
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Mexico · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- CS Distribuidora S.A. de C.V. (Plant)
09/10/2009
Mexico · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Farmacias Fantini
09/10/2009
Mexico · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
Mexico · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- JFW Enterprises (John William)
09/10/2009
Mexico · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- Mercantil Farmaceutica Patria
09/10/2009
Mexico · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
- RXMEX-Com SA de CV
09/10/2009
Mexico · Sildenafil Citrate (Regulator)
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