FDA import alert
Import Alert 68-19
DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS
76
Red-list entries
0
Green-list entries
24
Countries
2026-07-27
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 76 of 76 entries — search a specific firm on the free checker.
- Biopharm Australia Pty. Ltd.
03/31/2026
Australia · Pharmaceutic Necessities and Containers, N.E.C.; Pentosan Polysulfate Sodium (Uricosuric)
- Ceva Animal Health Pty Ltd
09/09/2015
Australia · Hormone N.E.C., Animal (Food Producing) - Non-Rx/Single Ingredient, NEC
- Prestige Blending
04/28/2021
Australia · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.; Amino Acid
- Value Plus Animal Health Care Pr
10/16/2023
Australia · Praziquantel/Pyrantel Pamoate combination (Antiparasitic); Ivermectin (Anti-Protozoal, A-Leishmanial, Anti-Malarial)
- Zoetis Australia Pty Ltd
12/12/2023
Australia · Human and Animal Drugs, Animal (Non-Food Producing) Rx/Comb Ingredient
- GHO AHK SPRL
09/30/2025
Belgium · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Homeopathic N.E.C.; Additives, N.E.C.
- Medichin N.V.
11/29/2016
Belgium · Herbals & Botanicals (not Teas), N.E.C.; Miscellaneous Patent Medicines, Etc.
- Reprobiol Sprl
12/10/2014
Belgium · Disposable/Sigle Use Devices, NEC (Nonhuman); Cages, including oxygen cages (Nonhuman); Hematology Analyzer (Nonhuman)
- Lavizoo-Lab Vitamins and Zootechnics
07/31/2024
Brazil · Clenbuterol (Bronchodilator); Bronchodilator N.E.C.
- Adored Beast Apothecary
08/24/2016
Canada · Vegetable Oils; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Animal Devices and Diagnostic Products
- Alcon Canada Inc
05/10/2017
Canada · Neomycin (Aminoglycosides); Neomycin, N.E.C. (Aminoglycosides); Polymyxin B Sulfate (Peptides)
- Boehringer Ingelheim Canada
09/06/2024
Canada · Analgesic, N.E.C.; Sedative N.E.C.
- Groupe Parima Inc.
07/05/2017
Canada · Miconazole Nitrate (Anti-Fungal) (Not Antibiotic)
- Mineral Medix Solutions Inc.
08/19/2020
Canada · Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations); Foot Powders and Sprays (Skin Care Preparations); Antifungal N.E.C.
- NaturPet Inc.
04/20/2018
Canada · Herbals & Botanicals (not Teas), N.E.C.; Miscellaneous Patent Medicines, Etc.
- Natures Formulae Health Products Ltd.
04/20/2018
Canada · Herbals & Botanicals (not Teas), N.E.C.; Miscellaneous Patent Medicines, Etc.
- Nu Paradigm Animal Health Ltd.
01/13/2020
Canada · Scabicide
- Omega Alpha Pharmaceuticals
03/04/2020
Canada · Vitamin, N.E.C.; L-Lysine (Protein); Herbals & Botanicals (not Teas), N.E.C.
Canada · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C., Enrich Anml Fd; Miscellaneous Patent Medicines, Etc., Animal (Non-Food Producing) Rx/Comb Ingredient
- life spring mfg ltd
07/19/2019
Canada · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Miscellaneous Patent Medicines, Etc.
China · Vitamins
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Human and Animal Drugs
- Mr. Su
01/13/2020
China · Hemp Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
- Mutian
01/21/2020
China · Miscellaneous Patent Medicines, Etc.
China · Vitamins
- Nantong MUTIAN Biotechnology Co., Ltd
01/21/2020
China · Miscellaneous Patent Medicines, Etc.
China · Exhibits - Other Drug Related Items N.E.C.; Pet Cat Food N.E.C.; Other Pet Food, N.E.C.
- SHANDONG NATURAL MICRON PHARM TE
05/19/2026
China · Analgesic, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Shandong Bozhongyuan Biotech Co
08/01/2017
China · Anti-Inflammatory N.E.C.; Emollient, Lubricant, N.E.C.; Irrigation Solution N.E.C.
China · Analgesic, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Shantou Olive Pharmaceutical Co.,Ltd
08/15/2016
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Human and Animal Drugs
- THE CLICK LIFESTYLE SAS
07/30/2025
Colombia · Other Oral Hygiene Products, without Fluoride, N.E.C.; Cosmetic Packaging and Labeling, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Vetcur Biotec Aps
04/19/2016
Denmark · Vitamin, N.E.C.; Miscellaneous Patent Medicines, Etc.; Exhibits - Other Drug Related Items N.E.C.
- CHEMIPOWER OU
06/22/2026
Estonia · Anti-Inflammatory N.E.C.
- AB SCIENCE
07/02/2026
France · Antineoplastic, NEC; Tumor Necrosis Factor (TNF) Inhibitor, NEC; Inhibitor (Growth Factor) N.E.C.
- Centre Specialites Pharmaceutiques
07/02/2026
France · Antineoplastic, NEC; Tumor Necrosis Factor (TNF) Inhibitor, NEC; Inhibitor (Growth Factor) N.E.C.
- GHO AHK SPRL
09/30/2025
France · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Homeopathic N.E.C.; Additives, N.E.C.
- Virbac Sa
06/22/2015
France · Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas); Miscellaneous Patent Medicines, Etc.
- GEROCELL PHARMA GMBH
12/07/2021
Germany · Methionine (Acidifier); Miscellaneous Patent Medicines, Etc.; Animal Medical Devices, NEC
- COPPERFIELD EQUINE THERAPY
02/26/2018
Ireland · Angelica (Herbal & Botanicals, not Teas); Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Arava Pet Spa Ltd.
09/29/2023
Israel · Herbals & Botanicals (not Teas), N.E.C.; Anti-Inflammatory N.E.C.; Sulfsalazine (Anti-Inflammatory, Part II)
- Fatro Spa
07/16/2026
Italy · Vitamin B1 (Thiamine); Vitamin, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
- NATURAL PRO CO.,LTD.
09/08/2023
Korea (The Republic Of) · Vitamins; Pet Dog Food N.E.C.
- Laboratorios Tornel, S.A.
03/01/2018
Mexico · Dietary Conv Food/Meal Replacements; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Human and Animal Drugs
- Lebssa Sa De Cv
06/09/2015
Mexico · Vitamin A; Vit D; Vitamin E (Tocopherol)
- Parfarm Sa
07/16/2026
Mexico · Vitamin, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Nutrient/Tonic N.E.C.
- Zirin Laboratories De
07/16/2026
Mexico · Vitamin, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Nutrient/Tonic N.E.C.
- Belgica De Weerd, B.V.
10/17/2016
Netherlands · Vitamin A; Vitamin B1 (Thiamine); Vitamin B2 (Riboflavin)
- Honey Collection Ltd
06/06/2018
New Zealand · Moisturizing (Skin Care Preparations); Other Skin Care Preparations, N.E.C.; Miscellaneous Patent Medicines, Etc.
- South Pacific Sera Limited
12/10/2014
New Zealand · Disposable/Sigle Use Devices, NEC (Nonhuman); Cages, including oxygen cages (Nonhuman); Hematology Analyzer (Nonhuman)
- South Pacific Sera Limited
03/18/2019
New Zealand · Disposable/Sigle Use Devices, NEC (Nonhuman); Cages, including oxygen cages (Nonhuman); Hematology Analyzer (Nonhuman)
- ENSON LABORATORIES, INC.
07/26/2019
Philippines · Amoxicillin Trihydrate (Penicillin, Synthetically Produced); Miscellaneous Patent Medicines, Etc.
- EXCELLENCE POULTRY & LIVESTO
08/07/2019
Philippines · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
- Premium Lab
12/05/2016
Philippines · Piperazine (Anthelmintic); Anthelmintic, N.E.C.
- Afriplex (Pty) Ltd.
10/19/2016
South Africa · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Anti-Histaminic N.E.C.; Miscellaneous Patent Medicines, Etc.
- HERBEX PTY LIMITED
10/19/2016
South Africa · Foods with Supplemental Nutrients Added, with or without Artifical Sweetners; Anti-Histaminic N.E.C.; Miscellaneous Patent Medicines, Etc.
- OPHTHALMICA PTY LTD
07/10/2025
South Africa · Herbals & Botanicals (not Teas), N.E.C.; Sodium Phosphate P 32 (Radioactive Agent); Miscellaneous Patent Medicines, Etc.
- SOUTHERN MEDICAL (PTY) LTD
07/10/2025
South Africa · Herbals & Botanicals (not Teas), N.E.C.; Sodium Rose Bengal I 125 (Radioactive Agent); Miscellaneous Patent Medicines, Etc.
- Southern Implants, (Pty.) Ltd.
07/10/2025
South Africa · Herbals & Botanicals (not Teas), N.E.C.; Sodium Phosphate P 32 (Radioactive Agent); Miscellaneous Patent Medicines, Etc.
- Laboratorios Calier S.A.
12/10/2014
Spain · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
- Laboratorios Calier, S.A.
08/07/2019
Spain · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
- Enzymatica AB
03/13/2015
Sweden · A-Fungal; A-Infective, Topical; A-Inflammatory
- PESCHKE TRADE GMBH
07/10/2025
Switzerland · Herbals & Botanicals (not Teas), N.E.C.; Sodium Phosphate P 32 (Radioactive Agent); Miscellaneous Patent Medicines, Etc.
- Peschke Meditrade
07/10/2025
Switzerland · Herbals & Botanicals (not Teas), N.E.C.; Sodium Phosphate P 32 (Radioactive Agent); Miscellaneous Patent Medicines, Etc.
- Peschke Meritrade Gmbh
07/10/2025
Switzerland · Herbals & Botanicals (not Teas), N.E.C.; Sodium Phosphate P 32 (Radioactive Agent); Miscellaneous Patent Medicines, Etc.
- Peschke Trade Gmbh
07/10/2025
Switzerland · Herbals & Botanicals (not Teas), N.E.C.; Sodium Phosphate P 32 (Radioactive Agent); Miscellaneous Patent Medicines, Etc.
- A. Nelson & Co., Ltd.
04/21/2025
United Kingdom · Relaxant N.E.C.; Miscellaneous Patent Medicines, Etc.
- Aromesse Ltd
07/23/2020
United Kingdom · Shampoos (Hair Preparations, Non-coloring); Lipstick (Makeup Preparations, not for Eyes); Moisturizing (Skin Care Preparations)
- Boehringer Ingleheim Limited
08/31/2023
United Kingdom · Pergolide Mesylate (Anti-Parkinsonian)
- HILTON HERBS LTD
10/22/2021
United Kingdom · Milk Thistle; Milk Thistle (Herbal & Botanical other than teas); Aloe (Herbal and Botanical (not teas) II (continued))
- Kusuri Products Limited
12/17/2019
United Kingdom · Benzalkonium Chloride (Pharmaceutic Necessity - Preservative); Iodine (Anti-Infective, Topical); Anti-Infective, Topical N.E.C.
- Optimised Energetics Limited
03/07/2016
United Kingdom · Antifungal N.E.C.; Anti-Bacterial, N.E.C.; Anti-Microbial N.E.C.
- Superfix Supplements Ltd
06/02/2017
United Kingdom · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Exhibits - Other Drug Related Items N.E.C.; Animal Feeds, N.E.C.
- Dr. Xie's Jing-Tang Herbal, Inc.
08/10/2016
United States · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Human and Animal Drugs
- Noahs Arc Inc
11/29/2016
United States · Herbals & Botanicals (not Teas), N.E.C.; Miscellaneous Patent Medicines, Etc.
- Pet Pawsitive
01/13/2020
United States · Hemp Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Does this alert touch your supply chain? Watch your suppliers from $19/mo →