FDA import alert
Import Alert 66-66
APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122
253
Red-list entries
0
Green-list entries
35
Countries
2023-12-26
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.
One-time pilot · $24.50
Need a dated record for a firm on this alert?
Open any firm below to see its full FDA import alert record for free, then request a source-linked Supplier Evidence Snapshot for your supplier file: red / green status, every matched alert, dates, official FDA links and the dataset timestamp.
Is your supplier on this alert?
Review the firms below and verify each match on the official FDA source. Watch subscriptions and automated email alerts are not available to start.
Red-list entries by country
+ 10 more countries
Firms on this red list
Showing 100 of 253 entries — search a specific firm on the free checker.
- IDT Australia Ltd.
09/30/2009
Australia · Minocycline Hydrochloride (Tetracyclines)
- Sandoz GmbH
09/30/2009
Austria · Kanamycin Sulfate (Aminoglycosides); Rifampin
- Allied Signal
09/30/2009
Bahamas · Naproxen (Anti-Inflammatory), Active Pharm Ingred/Chems for Further Manuf
- Pharmaceutical Fine Chemicals Ltd
09/30/2009
Bahamas · Doxazosin Mesylate (Anti-Hypertensive - Part II), Active Pharm Ingred/Chems for Further Manuf
- ALCON-COUVREUR N.V.
09/30/2009
Belgium · Brinzolamide (Vasoconstrictor), Active Pharm Ingred/Chems for Further Manuf
- Acros Organics B.V.B.A.
09/30/2009
Belgium · Oxytetracycline Hydrochloride (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf
- Pfizer Service Company
09/30/2009
Belgium · Doxazosin Mesylate (Anti-Hypertensive - Part II)
- MERKABA CORP. LTD.
12/30/2016
Bulgaria · 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.
- Apotex Pharmachem Inc.
09/30/2009
Canada · Fluvoxamine Maleate (Anti-Depressant), Active Pharm Ingred/Chems for Further Manuf; Buspirone HCl (Tranquilizer), Active Pharm Ingred/Chems for Further Manuf
- Choisy Laboratories Ltd
09/30/2009
Canada · Penicillin G, Natural, Active Pharm Ingred/Chems for Further Manuf; Penicillin V, Natural, Active Pharm Ingred/Chems for Further Manuf; Penicillin Natural, N.E.C., Active Pharm Ingred/Chems for Further Manuf
- Delpharm Montreal Inc.
09/30/2009
Canada · Progesterone (Progestin), Active Pharm Ingred/Chems for Further Manuf
- Forchem Canada Ltd
09/30/2009
Canada · Clindamycin Phosphate (Lincomycins), Active Pharm Ingred/Chems for Further Manuf
- Formulex Canada Inc.
09/30/2009
Canada · Piroxicam (Anti-Inflammatory), Active Pharm Ingred/Chems for Further Manuf
- Intergen Biomanufacturing Corp.
09/30/2009
Canada · Insulin Purified Beef (Anti-Diabetic), Active Pharm Ingred/Chems for Further Manuf
- PF Soins de Sante SRI
09/30/2009
Canada · Immunosuppress N.E.C.
- Patheon Inc.
09/30/2009
Canada · Night (Skin Care Preparations); Polyethylene Glycol 1500 (Pharmaceutic Necessity - Ointment Base)
- Prinova Canada
09/30/2009
Canada · Tetracycline Hydrochloride (Tetracyclines)
- RTP Pharma, Inc.
09/30/2009
Canada · Cyclosporine (Anti-Inflammatory), Active Pharm Ingred/Chems for Further Manuf
- Wyeth-Ayerst Canada Inc
09/30/2009
Canada · Gonadorelin HCl (Gonad-Stimulating Principle), Active Pharm Ingred/Chems for Further Manuf
- Anhui
09/30/2009
China · Heparin Sodium (Anti-Coagulant), Active Pharm Ingred/Chems for Further Manuf
- Auspure Biotechnolgy Co., Ltd.
09/30/2009
China · Cholinergic N.E.C., Active Pharm Ingred/Chems for Further Manuf
- CHENGDU SANHERB BIOSCIENCE CO.,LTD
07/28/2016
China · Tea Substitutes, N.E.C.; Vitamin, N.E.C.; L-Tryptophan (Protein)
China · Prednisolone (Glucocorticoid), Active Pharm Ingred/Chems for Further Manuf
- Chengdu Mechem Medicines & Chemicals Co.
09/30/2009
China · Oxytetracycline (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf
- China Export Bases Development Corp
09/30/2009
China · Gentamicin (Aminoglycosides), Active Pharm Ingred/Chems for Further Manuf; Streptomycin (Aminoglycosides), Active Pharm Ingred/Chems for Further Manuf; Oxytetracycline (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf
- China Hunam Walion Imp & Exp Corp
09/30/2009
China · Heparin Sodium (Anti-Coagulant), Active Pharm Ingred/Chems for Further Manuf
China · Trimethoprim (Anti-Bacterial), Active Pharm Ingred/Chems for Further Manuf
China · Testosterone (Androgen), Active Pharm Ingred/Chems for Further Manuf
China · Trimethoprim (Anti-Bacterial), Active Pharm Ingred/Chems for Further Manuf
China · Promethazine HCl (Anti-Emetic/Nauseant), Active Pharm Ingred/Chems for Further Manuf
- Deko Industry
04/05/2016
China · Herbals & Botanicals (not Teas), N.E.C.; Lovastatin (Anti-Cholesteremic)
- Fujian South Pharmaceutical Co. Ltd
08/14/2012
China · Paclitaxel (Anti-Neoplastic)
- GUANGDONG RUNJIA CASING CO., LTD.
10/07/2014
China · Heparin Sodium (Anti-Coagulant)
- Guangdong Techpool Biochem Pharma (GTBP)
06/04/2015
China · Urokinase (Plasminogen Activator)
China · Anti-Cholinergic, N.E.C.; Stimulant N.E.C.
- Guangzhou Topwork Chemical Co., Ltd.
01/22/2010
China · Cardiotonic N.E.C.
- He Nan Yong Qi Chemicals Co.Ltd
09/30/2009
China · Diclofenac Sodium (Anti-Inflammatory)
- Huaiyin Wellkong Bioeng
09/30/2009
China · Heparin Sodium (Anti-Coagulant), Active Pharm Ingred/Chems for Further Manuf
- Huashu Pharmaceutical Corporation
09/30/2009
China · Oxytetracycline (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf
- Huazhong Pharmaceutical Co., Ltd
09/30/2009
China · Progesterone (Progestin)
- Hubei Fangtong Pharmaceutical Co., Ltd.
03/16/2016
China · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Pregnenolone Succinate (Glucocorticoid)
- Hubei Prosperty Galaxy Chemical Co., LTD
06/28/2013
China · Procaine HCl (Anesthetic); Inositol Niacinate (Vasodilator)
China · Progesterone (Progestin), Active Pharm Ingred/Chems for Further Manuf
China · Progesterone (Progestin)
- Jiangsu Sainty International Group
09/30/2009
China · Flucytosine (Anti-Fungal) (Not Antibiotic), Active Pharm Ingred/Chems for Further Manuf
- Jiangsu Tianhe Pharmaceutical Co.
02/07/2020
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Sulfacetamide Sodium (Anti-Bacterial) (Not Antibiotic); Sodium Sulfacetamide (Anti-Bacterial, Part III)
- Jiangsu Yabang Group Co.
09/30/2009
China · Albendazole (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Bio & Licensed In-Vivo & In-Vitro Diag
- Jinan Haohua Industry Co., Ltd
12/29/2015
China · Skin Care Prep; Cosmetic Raw Material; Ultraviolet Screen/Sunscreen N.E.C.
China · Adenosine (Cardiac Depressant (Anti-Arrhythmic))
- Machinex Ninbo Ltd
09/30/2009
China · Oxytetracycline (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf
- Nanhai Beisha Medical Material Factory
09/30/2009
China · Sulfamethazine (Anti-Bacterial) (Not Antibiotic), Active Pharm Ingred/Chems for Further Manuf
- Nanjing Machinery
09/30/2009
China · Sucralfate (Antacid), Active Pharm Ingred/Chems for Further Manuf
China · Triazolam (Sedative), Active Pharm Ingred/Chems for Further Manuf
China · Ketoconazole (Anti-Fungal) (Not Antibiotic)
- QINGDAO HEADER INTERNATIONAL CO., LTD.
03/16/2016
China · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Pregnenolone Succinate (Glucocorticoid)
- SHANDONG LUYE PHARMACEUTICAL CO., LTD
06/04/2015
China · Urokinase (Plasminogen Activator)
China · Kanamycin (Aminoglycosides), Active Pharm Ingred/Chems for Further Manuf
China · Gentamicin (Aminoglycosides), Active Pharm Ingred/Chems for Further Manuf
- Shaanxi Guanjie Technology Co Ltd
07/15/2019
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Bio & Licensed In-Vivo & In-Vitro Diag
China · Food Additives For Human Use, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.
China · Food Additives For Human Use, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.
- Shandong Foreign Trading Mingda Co.
09/30/2009
China · Lincomycin N.E.C., Active Pharm Ingred/Chems for Further Manuf
- Shandong Ju County Foreign Trade Canned
09/30/2009
China · Kanamycin (Aminoglycosides), Active Pharm Ingred/Chems for Further Manuf
- Shandong Lukang Pharmaceutical Co. Ltd.
09/30/2009
China · Streptomycin (Aminoglycosides), Active Pharm Ingred/Chems for Further Manuf
- Shandong Lukang Record Pharmaceutical
12/16/2014
China · Cefdinir (Cephalosporins)
China · Cefdinir (Cephalosporins)
- Shandong Yinfeida Pharmaceutical
07/11/2011
China · Terbinafine Hydrochloride (Anti-Fungal) (Not Antibiotic)
- Shanghai Buddy International Trading Co.
09/30/2009
China · Progesterone (Progestin), Active Pharm Ingred/Chems for Further Manuf
- Shanghai Deko Industry Co Ltd
04/05/2016
China · Herbals & Botanicals (not Teas), N.E.C.; Lovastatin (Anti-Cholesteremic)
- Shanghai Exceed Dragon Intl. Trade Corp.
09/30/2009
China · Dihydrostreptomycin (Aminoglycosides), Active Pharm Ingred/Chems for Further Manuf; Tetracycline (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf
- Shanghai Kj Import & Export Corp.
09/30/2009
China · Gentamicin (Aminoglycosides), Active Pharm Ingred/Chems for Further Manuf
- Shanghai Kj No.6 Pharmaceuticals
09/30/2009
China · Gentamicin (Aminoglycosides), Active Pharm Ingred/Chems for Further Manuf
- Shanghai Shenghua
12/17/2012
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Pharmaceutic Necessities, N.E.C.; Miscellaneous Patent Medicines, Etc.
China · Sulfadiazine (Anti-Bacterial) (Not Antibiotic), Active Pharm Ingred/Chems for Further Manuf
- Shanghai Worldbest Industry
09/30/2009
China · Procaine HCl (Anesthetic), Active Pharm Ingred/Chems for Further Manuf
- Shanghai Zillionaire Chemicals Inc.
09/30/2009
China · Chelating Agent N.E.C.
- Shijiazhuang Pharmaceutical Factory
09/30/2009
China · Oxytetracycline (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Sulfacetamide Sodium (Anti-Bacterial) (Not Antibiotic); Sodium Sulfacetamide (Anti-Bacterial, Part III)
- Sichuan Yibin Foreign Economic Dev
09/30/2009
China · Oxytetracycline (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf
China · Oxacillin Sodium (Penicillin, Synthetically Produced), Active Pharm Ingred/Chems for Further Manuf; Adrenocortical Steroid N.E.C., Active Pharm Ingred/Chems for Further Manuf
- Sinochem Zhuhai Co.Ltd.
09/30/2009
China · Procaine HCl (Anesthetic), Active Pharm Ingred/Chems for Further Manuf
- Sinocrem Bebei Imporrt & Export Corp.
09/30/2009
China · Tetracycline (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf
China · Ribavirin (Anti-Viral), Active Pharm Ingred/Chems for Further Manuf
China · Baclofen (Relaxant)
- Suzhou MyLand Pharm&Nutrition Inc.
05/31/2017
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Stimulant N.E.C.; Miscellaneous Patent Medicines, Etc.
- Suzhou MyLand Pharm&Nutrition Inc.
11/17/2014
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
- Suzhou No 1 Garment Factory
09/30/2009
China · Lincomycin N.E.C., Active Pharm Ingred/Chems for Further Manuf
China · Methocarbamol (Relaxant), Active Pharm Ingred/Chems for Further Manuf
- Wujin Jianhu Silk Printing Mill
09/30/2009
China · Progesterone (Progestin), Active Pharm Ingred/Chems for Further Manuf
China · Phenylbutazone (Anti-Rheumatic), Active Pharm Ingred/Chems for Further Manuf
- XI AN JKA BIOTECH CO., LTD
12/26/2023
China · Hormone (Skin Care Preparations); Moisturizing (Skin Care Preparations); Progesterone (Progestin)
- Xianju xiner pharmaceuticals & Chemicals
11/21/2014
China · Progesterone (Progestin)
- Yancheng Suhai Pharmaceutical Co., Ltd.
09/30/2009
China · Doxycycline (Tetracyclines); Doxycycline Monohydrate (Tetracyclines); Doxycycline Hyclate (Tetracyclines)
- Yang Zhou Pharmeutical Factor
09/30/2009
China · Teroxalene HCl (Anti-Schistosomal), Active Pharm Ingred/Chems for Further Manuf
China · Progesterone (Progestin), Active Pharm Ingred/Chems for Further Manuf
- Yicheng Goto Pharmaceuticals Co., Ltd
04/29/2016
China · Anti-Estrogen N.E.C.; Estrogen N.E.C.
- Zhejiang Medicines & Heal
09/30/2009
China · Doxorubicin Hydrochloride (Antitumor), Active Pharm Ingred/Chems for Further Manuf; Daunorubicin Hydrochloride (Antitumor), Active Pharm Ingred/Chems for Further Manuf; Mitomycin (Antitumor), Active Pharm Ingred/Chems for Further Manuf
- Pliva - Kalinovica
09/30/2009
Croatia · Atovaquone (Anti-Protozoal, A-Leishmanial, Anti-Malarial), Active Pharm Ingred/Chems for Further Manuf
- Pliva Croatia
04/03/2019
Croatia · Mesalamine (Analgesic), Active Pharm Ingred/Chems for Further Manuf
Does this alert touch your supply chain? Check monitoring availability →