U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Enforcement Activities | FDA
  5. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
  6. Warning Letters 2020
  1. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Warning Letters 2020

These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion and CDER Headquarters Warning Letters. For District Office Warning Letters see the Main FDA FOI Warning Letters Page. Some of the letters have been redacted or edited to remove confidential information. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.     

If you wish to obtain available additional information on the current status of an issue in a particular warning letter or notice of violation on this website, please contact the Agency or the recipient of the letter directly. Inquiries to FDA should be sent to: 

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane, Rockville, MD 20857

Instructions for how to submit an FOI request can be found on the FDA Freedom of Information Page.

Office of Prescription Drug Promotion

Company/Individual

Product/Issue

Issue Date

Nephron Pharmaceuticals Corporation

ANDA 78202 Budesonide Inhalation Suspension, for inhalation suspension (COVID Related) 9/22/2020

Nalpropion Pharmaceuticals LLC

NDA 200063 CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) extendedrelease tablets, for oral use 9/22/2020

Sprout Pharmaceuticals, Inc

NDA 022526 ADDYI (flibanserin) tablets, for oral use 8/31/2020

Xeris Pharmaceuticals, Inc.

NDA 212097 GVOKETM (glucagon) injection, for subcutaneous use  8/14/2020

Outlook Pharmaceuticals, Inc.

ANDA 040776 PROCENTRA® (dextroamphetamine sulfate) oral solution, CII

2/21/2020

Back to Top

Office of Compliance/Immediate Office 

Company/Individual

Product/Issue

Issue Date

 

   

Office of Manufacturing Quality

Company/Individual

Product/Issue

Issue Date

Quimica Magna de Mexico, S.A. de C.V.

CGMP/Adulterated - Hand Sanitizer Products 10/15/2020

Shilpa Medicare Limited

CGMP/Finished Pharmaceuticals/Adulterated 10/9/2020

LEC Custom Products, Inc.

CGMP/Finished Pharmaceuticals/Adulterated 9/24/2020

Panacea Biotec Limited

CGMP/Finished Pharmaceuticals/Adulterated 9/24/2020

Mayon's Pharmaceuticals Pvt Ltd

CGMP/Finished Pharmaceuticals/Adulterated 9/4/2020

Windlas Healthcare Private Limited

CGMP/Finished Pharmaceuticals/Adulterated 3/10/2020

Yibin Lihao Bio-technical Co., Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 2/13/2020

Sunstar Guangzhou Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 1/22/2020

Dental-Kosmetik GmbH & Co. KG

CGMP/Finished Pharmaceuticals/Adulterated 1/16/2020

Cosmelab Co Ltd

CGMP/Finished Pharmaceuticals/Adulterated 1/9/2020

Zhuhai Aofute Medical Technology Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 1/9/2020

Huaian Zongheng Bio-Tech Co., Ltd

CGMP/Finished Pharmaceuticals/Adulterated 1/9/2020

 

Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date

James R. Corbett, M.D.

Sponsor/Investigator 2/27/2020

 

Office of Unapproved Drugs and Labeling Compliance

Company/Individual

Product/Issue

Issue Date

For Our Vets LLC dba Patriot Supreme

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 10/16/2020

Oneness Labs

Unapproved and Misbranded Products 10/7/2020

Prairie Dawn Herbs

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 10/7/2020

Griffo Botanicals

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 10/7/2020

Haloderm, Inc.

Unapproved and Misbranded Products 10/6/2020

USARxMedicine

Notice of Unlawful Sale of Unapproved and Misbranded Opioids to United States Consumers Over the Internet 10/1/2020

Tonic Therapeutic Herb Shop & Elixir Bar

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 9/29/2020

Pharmacy Plus, Inc. dba Vital Care Compounder

Unapproved and Misbranded Products 9/9/2020

Medication-house.com

Unapproved and Misbranded Products 9/2/2020

Extrapharma.com

Unapproved and Misbranded Products 9/2/2020

alpharoyalpharmacy.com 

Unapproved and Misbranded Products 9/2/2020

bluepillmedications.com 

Unapproved and Misbranded Products 9/2/2020

melanopharmacy.com 

Unapproved and Misbranded Products 9/2/2020

beststeroidstore.net 

Unapproved and Misbranded Products 9/2/2020

1 Party At A Time

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 9/1/2020

www.xsteroids.com 

Unapproved and Misbranded Products 8/31/2020

klasiekpharmacy.com 

Unapproved and Misbranded Products 8/31/2020

www.skylimitpharmacy.com 

Unapproved and Misbranded Products 8/31/2020

www.roidsforce.com 

Unapproved and Misbranded Products 8/31/2020

www.rxeasymeds.com

Unapproved and Misbranded Products 8/31/2020

genericpharmacyusa.com 

Unapproved and Misbranded Products 8/31/2020

lekapharma.com

Unapproved and Misbranded Products 8/31/2020

greenrxpharmacy.com 

Unapproved and Misbranded Products 8/31/2020

www.uspharmacyshop.com 

Unapproved and Misbranded Products  8/31/2020

IceNetworks Ltd./www.mega-pillspharmacy.com 

Unapproved and Misbranded Products  8/31/2020

www.buydrugsmedsonline.com 

Unapproved and Misbranded Products  8/31/2020

Thomas Meds

Unapproved and Misbranded Products  8/26/2020

Living Senior, LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 8/19/2020

SilveryGuy

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 8/14/2020

Oxford Medical Instruments USA, Inc.

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 8/11/2020

H-Lab Life

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 8/7/2020

Canadian Chaga

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 8/6/2020

MMSTabs.com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 8/3/2020

Vapore LLC dba Mypurmist

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 7/30/2020

Kegan Wellness

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 7/13/2020

Health Beauty Love

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 7/10/2020

Hydroxychloroquine-online.com

Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (COVID-19) 7/9/2020

Pharmaboosters.com

Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (COVID-19) 7/9/2020

Ionogen, LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 7/7/2020

Shen Clinic, LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 7/7/2020

SinoTradition.com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 7/6/2020

Lianhuaqingwencaps.com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 7/6/2020

Lotus Herbal Supplements

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 7/6/2020

Butterfly Expressions LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 7/6/2020

Center for Wellness and Integrative Medicine

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 6/30/2020

SuperHealthGuard and Loyal Great International Ltd.

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 6/26/2020

Nuance Health, LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 6/26/2020

Curativa Bay Corporation

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 6/25/2020

North Isle Wellness Center

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 6/19/2020

Project 1600 Inc.

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 6/18/2020

www.outoftheboxremedies.com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 6/10/2020

organic-beauty-recipes.com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 6/8/2020

Quadrant Sales & Marketing, Inc.

Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) 5/28/2020

StayWell Copper Products

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/28/2020

Musthavemom.com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/26/2020

Alternavita

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/26/2020

CBD Gaze

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/26/2020

Careful Cents, LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/26/2020

Apollo Holding LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/21/2020

Life Unlearned, LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/19/2020

SpiceTac

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/19/2020

Chloroquineonline.com

Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID-19) to United States Consumers Over the Internet    5/18/2020

Noetic Nutraceuticals

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/15/2020

The Golden Road Kratom

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/15/2020

White Eagle Native Herbs

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/14/2020

benjaminmcevoy.com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/14/2020

4nrx.md

Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID-19) to United States Consumers Over the Internet 5/13/2020

Fusion Health and Vitality LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/11/2020

Plum Dragon Herbs, Inc.

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/8/2020

Seanjari Preeti Womb Healing, L.L.C.

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/8/2020

AgroTerra, Ltd. dba Patriot Hemp Company

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/7/2020

WashingtonsLastFrontier.Com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/7/2020

Chronic Lyme Treatment

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/7/2020

Sanit Technologies LLC dba Durisan

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/7/2020

Alive By Nature, Inc.

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/6/2020

GlutaGenic

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/6/2020

Dr. Dhole's Sushanti Homeopathy Clinic

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/4/2020

Honey Colony LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/4/2020

Hopewell Essential Oils

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/27/2020

Santiste Labs LLC

Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) 4/27/2020

Prefense LLC

Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19) and Other Diseases 4/23/2020

Antroids.com

Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID-19) to United States Consumers Over the Internet 4/22/2020

Foxroids.com

Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID-19) to United States Consumers Over the Internet    4/22/2020

Emedkit.com

Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID-19) to United States Consumers Over the Internet    4/22/2020

Roidsmall.net

Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID-19) to United States Consumers Over the Internet  4/22/2020

Copper Touch, LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/21/2020

Homero Corp DBA Natures CBD Oil Distribution

Unapproved and Misbranded products containing cannabidiol (CBD) 4/20/2020

Nova Botanix LTD DBA CanaBD

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/16/2020

The Art Of Cure

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/15/2020

Earth Angel Oils

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/14/2020

The GBS dba Alpha Arogya India Pvt Ltd

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/13/2020

Gaia Arise Farms Apothecary

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/13/2020

Herbs of Kedem

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/10/2020

BIOTA Biosciences LLC

Unapproved and Misbranded Products 4/9/2020

Earthley Wellness dba Modern Alternative Mama LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/9/2020

Free Speech Systems LLC d.b.a. Infowars.com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/9/2020

NRP Organics Ltd

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/8/2020

Genesis 2 Church

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/8/2020

Savvy Holistic Health dba Holistic Healthy Pet

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/7/2020

CBD Online Store

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/7/2020

Ananda, LLC DBA Ananda Apothecary

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/6/2020

Native Roots Hemp

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/6/2020

Indigo Naturals

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/6/2020

Cathay Natural, LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/6/2020

Alternative Health Experts LLC DBA Immunization Alternatives

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/6/2020

Health Mastery Systems DBA Pure Plant Essentials

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/1/2020

Homeomart Indibuy

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/1/2020

Gaia's Whole Healing Essentials, LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/1/2020

NeuroXPF

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/31/2020

Unitedpharmacies.md

Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID‐19) to United States Consumers Over the Internet 3/30/2020

JRB Enterprise Group Inc. DBA Anti Aging Bed

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/30/2020

Halosense Inc.

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/30/2020

Bioactive C60/FullerLifeC60 LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/30/2020

Carahealth

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/26/2020

Corona-cure.com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)           3/26/2020

Quinessence Aromatherapy LTD

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/6/2020

GuruNanda LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/6/2020

Colloidal Vitality LLC/Vital Silver

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/6/2020

Xephyr, LLC dba N-Ergetics

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/6/2020

Vivify Holistic Clinic

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/6/2020

Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

 

   

 

 

Back to Top