We list here warning letters issued by FDA to pharmaceutical manufacturing facilities. You can check the details of warning letter by clicking on the name of the company.
Warning Letters Issued in 2025
| Date |
Issued to Company |
Country |
| 13/11/2025
|
Cdymax India Pharma Private Limited
|
India
|
| 03/11/2025
|
Miers Laboratories, Ltd
|
New Zealand
|
| 31/10/2025
|
Apotex Inc.
|
Canada
|
| 21/10/2025
|
Uriel Pharmacy, Inc.
|
United States
|
| 10/10/2025
|
Acme United Corporation
|
United States
|
| 30/09/2025
|
Guangxi Yulin Pharmaceutical Group Co. Ltd.
|
China
|
| 11/09/2025
|
Chengdu Brilliant Biopharmaceutical Co., Ltd.
|
China
|
| 04/09/2025
|
Somerset Therapeutics Private Limited
|
United States
|
| 27/08/2025
|
Amneal Pharmaceuticals, LLC
|
United States
|
| 22/08/2025
|
Wisconsin Pharmacal Company, LLC
|
United States
|
| 20/08/2025
|
Hikal Limited
|
India
|
| 23/07/2025
|
Shiva Analyticals Private Limited
|
India
|
| 11/07/2025
|
Glenmark Pharmaceuticals Limited
|
India
|
| 02/07/2025
|
Daewoo Pharmaceutical Co., Ltd.
|
South Korea
|
| 02/07/2025
|
Exela Pharma Sciences, LLC
|
United States
|
| 27/06/2025
|
Libby Laboratories, Inc.
|
United States
|
| 12/06/2025
|
Kenil Healthcare Private Limited
|
India
|
| 29/05/2025
|
Laboratoire Druide Inc.
|
Canada
|
| 27/05/2025
|
Yiling Pharmaceutical Ltd.
|
China
|
| 14/05/2025
|
Evi Labs LLC
|
United States
|
| 13/05/2025
|
AACE Pharmaceuticals, Inc.
|
United States
|
| 30/04/2025
|
Rechon Life Science
|
Sweden
|
| 24/04/2025
|
Huangshi Hygienic Material Medicine Co., Ltd.
|
China
|
| 09/04/2025
|
Dyno Manufacturing, Inc.
|
United States
|
| 09/04/2025
|
BEO Pharma Inc. dba BEO Pharmaceuticals Inc.
|
United States
|
| 14/03/2025
|
Advanced Pharmaceutical Technology
|
United States
|
| 10/03/2025
|
International Laboratories Corp
|
Thailand
|
| 05/03/2025
|
Macsen Drugs
|
India
|
| 05/03/2025
|
Aspen Biopharma Labs Private Limited
|
India
|
| 28/02/2025
|
Shree Jaya Laboratories Pvt. Ltd.
|
India
|
| 26/02/2025
|
Granules India Limited
|
India
|
| 25/02/2025
|
Linghai ZhanWang Biotechnology Co., Ltd
|
China
|
| 24/02/2025
|
Aspen Pharmacare Holdings Limited
|
South Africa
|
| 06/02/2025
|
Tyche Industries Ltd
|
India
|
| 05/02/2025
|
Jagsonpal Pharmaceuticals Limited
|
India
|
| 05/02/2025
|
Chengdu Innovation Pharmaceutical Co., Ltd.
|
China
|
| 15/01/2025
|
Sanofi
|
France
|
Warning Letters Issued in 2024
Warning Letters Issued in 2023
Warning Letters Issued in 2022
Warning Letters Issued in 2021
Warning Letters Issued in 2020
Warning Letters Issued in 2019
| Date |
Issued to Company |
Country |
| 31/12/2019
|
Henan Kangdi Medical Devices Co. Ltd
|
China
|
| 31/12/2019
|
GPT Pharmaceuticals Private Ltd
|
India
|
| 17/12/2019
|
Wild Child WA Pty Ltd.
|
Australia
|
| 11/12/2019
|
Alkermes, Inc.
|
United States
|
| 12/11/2019
|
Cadila Healthcare Limited
|
India
|
| 12/11/2019
|
Mylan Laboratories Limited
|
India
|
| 05/11/2019
|
Bingbing Pharmaceutical Co. Ltd.
|
China
|
| 09/10/2019
|
Coral Pharmaceuticals Limited
|
Bahamas
|
| 08/10/2019
|
Torrent Pharmaceuticals Limited
|
India
|
| 03/10/2019
|
Glenmark Pharmaceuticals Limited
|
India
|
| 12/09/2019
|
Dermameal Co., Ltd.
|
South Korea
|
| 10/09/2019
|
Lupin Ltd.
|
India
|
| 29/08/2019
|
Hangzhou Badi Daily Use Chemical Company
|
China
|
| 22/08/2019
|
Polimeros y Servicios S.A.
|
Costa Rica
|
| 19/08/2019
|
Haw Par Healthcare Limited
|
Singapore
|
| 16/08/2019
|
Metuchen Pharmaceuticals, LLC.
|
United States
|
| 15/08/2019
|
Enprani Co., Ltd.
|
South Korea
|
| 12/08/2019
|
Yino, Inc.
|
China
|
| 08/08/2019
|
Lantech Pharmaceuticals Limited
|
India
|
| 02/08/2019
|
NingBo Huize Commodity Co., Ltd.
|
China
|
| 02/08/2019
|
Emcure Pharmaceuticals Limited
|
India
|
| 16/07/2019
|
Indoco Remedies Limited
|
India
|
| 12/07/2019
|
CTX Lifesciences Private Ltd.
|
India
|
| 01/07/2019
|
Strides Pharma Science Limited
|
India
|
| 20/06/2019
|
Aurobindo Pharma Limited
|
India
|
| 13/06/2019
|
Rxhomeo Private Limited
|
India
|
| 29/05/2019
|
Vida International, Inc.
|
Taiwan
|
| 07/05/2019
|
Petra Hygienic Systems Int Ltd
|
Canada
|
| 04/05/2019
|
Centurion Laboratories Private Limited
|
India
|
| 23/04/2019
|
Laboratoires Clarins
|
France
|
| 04/04/2019
|
Luen Fook Medicine Sdn. Bhd.
|
Singapore
|
| 21/03/2019
|
B. Jain Pharmaceuticals Private
Limited
|
India
|
| 18/03/2019
|
Dong Yuan Technology Co., Ltd.
|
China
|
| 06/03/2019
|
Jubilant Generics Limited
|
India
|
| 04/03/2019
|
Hospira Healthcare India Pvt. Ltd.
|
India
|
| 28/02/2019
|
Anicare Pharmaceuticals Pvt Ltd.
|
India
|
| 25/02/2019
|
Laboratorios Quantium LLC
|
United States
|
| 25/02/2019
|
Vilvet Pharmaceutical
|
United States
|
| 13/02/2019
|
Proandre SL
|
Spain
|
| 29/01/2019
|
Hangzhou SunKing Nonwovens Co., Ltd.
|
China
|
| 29/01/2019
|
Vipor Chemicals Private Ltd.
|
India
|
| 10/01/2019
|
Vitalab Pharmacy, Inc.
|
United States
|
Warning Letters Issued in 2018
| Date |
Issued to Company |
Country |
| 14/12/2018
|
Longbow First Aid Products Manufactory
|
China
|
| 14/12/2018
|
Hangzhou Guoguang Touring Commodity Co.,Ltd.
|
China
|
| 13/12/2018
|
Samson Pharmaceuticals, Inc
|
United States
|
| 13/12/2018
|
Soleo
|
South Korea
|
| 03/12/2018
|
Skylark CMC Pvt. Ltd.
|
India
|
| 30/11/2018
|
Cao Medical Equipment Co., Ltd.
|
China
|
| 29/11/2018
|
Zhejiang Huahai Pharmaceutical
|
China
|
| 28/11/2018
|
Barox Co., Ltd.
|
South Korea
|
| 27/11/2018
|
Hangzhou Zhongbo Industrial Co., Ltd.
|
China
|
| 09/11/2018
|
Mylan Pharmaceuticals, Inc.
|
United States
|
| 22/10/2018
|
Vanda Pharmaceuticals
|
United States
|
| 03/10/2018
|
Hanlim Pharm Co., Ltd.
|
South Korea
|
| 24/09/2018
|
N-Molecular Inc. d.b.a. SOFIE
|
United States
|
| 10/09/2018
|
Wilson Medicine Company
|
India
|
| 05/09/2018
|
Jabones Y Productos Especializados SA de CV
|
Mexico
|
| 04/09/2018
|
Lernapharm (Loris) Inc.
|
Canada
|
| 27/08/2018
|
Longood Medicine (Beijing) Co Ltd
|
China
|
| 10/08/2018
|
Kyowa Hakko Bio Co., Ltd.
|
Japan
|
| 09/08/2018
|
Apotex Research Private Limited
|
India
|
| 01/08/2018
|
Bill Beauty and Health Products Ltd.
|
Canada
|
| 31/07/2018
|
Hangzhou Karic Commodities Co., Ltd.
|
China
|
| 27/07/2018
|
JT Cosmetics & Chemicals Pvt Ltd.
|
India
|
| 26/07/2018
|
Yicheng Goto Pharmaceuticals Co., Ltd
|
China
|
| 24/07/2018
|
Les Produits Chimiques B.G.R., Inc.
|
Canada
|
| 17/07/2018
|
Yuki Gosei Kogyo Co., Ltd.
|
Japan
|
| 05/07/2018
|
Claris Injectables Limited
|
India
|
| 27/06/2018
|
Zhuhai United Laboratories Co. Ltd.
|
China
|
| 26/06/2018
|
Foshan Jinxiong Technology Co., Ltd.
|
China
|
| 22/06/2018
|
Sichuan Friendly Pharmaceutical Co., Ltd.
|
China
|
| 12/06/2018
|
Henan Lihua Pharmaceutical Co., Ltd.
|
China
|
| 08/06/2018
|
BR SAS
|
France
|
| 31/05/2018
|
Taiwan Biotech Co., LTD.
|
Taiwan
|
| 23/05/2018
|
IDT Australia Ltd.
|
Australia
|
| 18/05/2018
|
Kolmar Korea Co. Ltd.
|
South Korea
|
| 18/05/2018
|
Jalco Cosmetics Pty Ltd.
|
Australia
|
| 16/05/2018
|
Europharma Concepts Limited
|
Ireland
|
| 14/05/2018
|
Jilin Shulan Synthetic Pharmaceutical Co. Ltd.
|
China
|
| 09/05/2018
|
Nox Bellcow Cosmetics Co. Ltd.
|
China
|
| 09/05/2018
|
Reine Lifescience
|
India
|
| 24/04/2018
|
Goran Pharma Pvt Ltd
|
India
|
| 19/04/2018
|
Lijiang Yinghua Biochemical and Pharmaceutical Co.,
Ltd.
|
China
|
| 18/04/2018
|
Degasa S.A. De C.V.
|
Mexico
|
| 09/04/2018
|
McCallum Manufacturing Ltd
|
United Kingdom
|
| 06/04/2018
|
Luen Wah (HK) Medicine Ltd
|
China
|
| 29/03/2018
|
Hanbul Cosmetics Co., Ltd
|
Korea
|
| 15/03/2018
|
Keshava Organics Pvt. Ltd.
|
India
|
| 09/03/2018
|
Malladi Drugs & Pharmaceuticals Ltd.
|
India
|
| 05/03/2018
|
Quali Controle & Qual-Controle-C.E.Bac
|
France
|
| 23/02/2018
|
Zhejiang Ludao Technology Co., Ltd.
|
China
|
| 23/02/2018
|
Nan San (HK) Pharmaceutical Factory Ltd.
|
China
|
| 16/02/2018
|
Alchymars ICM SM Private Limited
|
India
|
| 14/02/2018
|
Nowcos Co., Ltd
|
South Korea
|
| 12/02/2018
|
Casmara Cosmetics, S.A.
|
Spain
|
| 07/02/2018
|
Shanghai Weierya Daily Chemicals Factory
|
China
|
| 02/02/2018
|
Cosmecca Korea Co., Ltd.
|
North Korea
|
| 26/01/2018
|
Celltrion Inc.
|
South Korea
|
| 25/01/2018
|
Polaroisin International Co., Ltd.
|
Taiwan
|
| 18/01/2018
|
Daito Kasei Kogyo Co Ltd
|
Japan
|
| 11/01/2018
|
King Bio Inc.
|
United States
|
| 11/01/2018
|
Guna Inc.
|
United States
|
| 11/01/2018
|
Wong Lap Kwong Medicine Company Limited
|
China
|
| 09/01/2018
|
Hunan Norchem Pharmaceutical Co. Ltd.
|
China
|
| 01/01/2018
|
Yicheng Chemical Corp.
|
China
|
