Fraudulent Coronavirus Disease 2019 (COVID-19) Products
The U.S. Food and Drug Administration is issuing warning letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure coronavirus disease 2019 (COVID-19). We are actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA is exercising its authority to protect consumers from firms selling unapproved products and making false or misleading claims, including, by pursuing warning letters, seizures, injunctions or criminal prosecutions against products and firms or individuals that violate the law.
Report a website that you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements or cosmetics.
- Thai National Charged with Fraudulently Selling Unapproved Chloroquine Phosphate as A Treatment for Covid-19
- Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
- Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?
- FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products
- CDC - Counterfeit Respirators/Misrepresentation of NIOSH-Approval
- CDC - Buyer Beware: How to Avoid Scams, Fraud, & Rumor During an Emergency
- Flickr Album: Fraudulent Coronavirus Disease 2019 (COVID-19) Products
- FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for Sale
- Improper Use of Thermal Imaging Devices: FDA Safety Communication
- Health Fraud & COVID-19: What You Need to Know (Podcast)
- FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams
- Semana Nacional de Protección al Consumidor: La FDA se mantiene alerta para proteger a los consumidores de las estafas relacionadas con las vacunas contra el COVID-19
- Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
- 6 Tip-offs to Rip-offs: Don't Fall for Health Fraud Scams
- Purported Biotech Executive Charged with Introducing Misbranded Drug into Interstate Commerce for Distribution of "COVID-19 Vaccine"
- Maryland U.S. Attorney’s Office Seizes Two Domain Names Purporting to be Websites of Biotechnology Companies Developing Treatments for Covid-19
- FDA Protects Patients and Consumers from Fraud During COVID-19
- Utah Man Posing as Medical Doctor to Sell Baseless Coronavirus Cure Indicted on Fraud Charges
- Tulare County Man Indicted for Falsely Marketing Herbal Mixtures as FDA-Approved Treatment for COVID-19
- FDA Updates on Hand Sanitizers with Methanol
- FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk
- Chinese Manufacturer Charged with Exporting Misbranded and Defective Masks Falsely Purporting to be N95 Respirators
- Federal Court Issues Temporary Restraining Order against Fort Davis Businessman Offering Fraudulent Coronavirus Cures/Treatments
- Federal judge enters temporary injunction against Xephyr LLC doing business as N-Ergetics, preventing sale of Colloidal Silver Products for COVID-19
- FDA Continues to Combat Fraudulent COVID-19 Medical Products
- Former Naturopath Charged Criminally for Trafficking in Misbranded Drugs Claiming They Could Prevent COVID-19
- Court Orders Halt to Sale of Silver Product Fraudulently Touted as COVID-19 Cure
- Court Prohibits Dallas Wellness Center from Touting ‘Ozone Therapy’ as COVID-19 Treatment
- Federal judge enters emergency injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19
- Carmel Valley Physician Charged with Fraud for Selling Purported COVID-19 “Miracle Cure”
- FDA Warns Company Marketing Dangerous Chlorine Dioxide Products that Claim to Treat or Prevent COVID-19
- U.K. National Charged with Shipping Mislabeled and Unapproved ‘Treatments’ for Patients Suffering from COVID-19
- Consumer Update: Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
- FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits
- FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19
Warning Letters
Date Issued | Firm Name | Product Name and Image1 | Corrective Status |
---|---|---|---|
03/06/2020 | Xephyr LLC dba N-ergetics | Colloidal silver products, including Colloidal Silver 1100 PPM | |
03/06/2020 | GuruNanda, LLC | Essential oil products | * |
03/06/2020 | Quinessence Aromatherapy Ltd | Essential oil products | * |
03/06/2020 | Vivify Holistic Clinic | Formula #1, Formula #2, Formula #3, and Eupatorium perfoliatum (Boneset) | * |
03/06/2020 | Colloidal Vitality LLC | Products labeled to contain silver | * |
03/06/2020 | The Jim Bakker Show | Silver Sol Liquid and products labeled to contain silver | * |
03/06/2020 | Herbal Amy Inc. | Coronavirus Protocol (Coronavirus Boneset Tea, Coronavirus Cell Protection, Coronavirus Core tincture, Coronavirus Immune System, and Elderberry Tincture) | * |
03/26/2020 | Corona-cure.com | Corona-Cure Coronavirus Infection Prevention Nasal Spray | * |
03/26/2020 | Carahealth | Herbal products, including "Carahealth Immune" also referred to as "Immune Tonic" | |
03/30/2020 | Halosense Inc. | Salt therapy products | * |
03/30/2020 | JRB Enterprise Group Inc. DBA Anti Aging Bed | Colloidal silver products | * |
03/30/2020 | Bioactive C60/FullerLifeC60 LLC | "FullerLifeC60" | * |
03/31/2020 | Neuro XPF | Cannabidiol (CBD) products | * |
04/01/2020 | Homeomart Indibuy | Homeopathic drugs | * |
04/01/2020 | Gaia's Whole Healing Essentials, LLC | Colloidal silver products | * |
04/01/2020 | Health Mastery Systems DBA Pure Plant Essentials | Essential oil products | * |
04/06/2020 | Ananda, LLC DBA Ananda Apothecary | Essential oil products | * |
04/06/2020 | Alternative Health Experts LLC DBA Immunization Alternatives | Homeopathic drugs and dietary supplement products | |
04/06/2020 | Cathay Natural, LLC | Herbal products including "CoronaDefender Herbal Sachet-S" | * |
04/06/2020 | Native Roots Hemp | Cannabidiol (CBD) products | * |
04/06/2020 | Indigo Naturals | Cannabidiol (CBD) products | * |
04/07/2020 | CBD Online Store | Cannabidiol (CBD) products | * |
04/07/2020 | Savvy Holistic Health dba Holistic Healthy Pet | "China Oral Nosode,” also called “China Corona Nosode," and the “CV Respiratory Kit,” under the description “AN330 – CORONA VIRAL IMMUNE SUPPORT AND/OR ACTIVE RESPIRATORY INFECTION FOR ALL AGES” | * |
04/08/2020 | Genesis 2 Church | Miracle Mineral Solution (MMS) (chlorine dioxide) | |
04/08/2020 | NRP Organics Ltd | "Fortify Humic Beverage Concentrate” and “Electrify Fulvic Beverage Concentrate” | * |
04/09/2020 | Free Speech Systems LLC d.b.a. Infowars.com | “Superblue Silver Immune Gargle,” “SuperSilver Whitening Toothpaste,” “SuperSilver Wound Dressing Gel” and “Superblue Fluoride Free Toothpaste” | * |
04/09/2020 | Earthley Wellness dba Modern Alternative Mama LLC | Herbal tinctures and herbal remedy products | * |
04/10/2020 | Herbs of Kedem | Herbal products | * |
04/13/2020 | Gaia Arise Farms Apothecary | “True Viral Defense,” also referred to as “Viral Defense Tincture” | * |
04/13/2020 | The GBS dba Alpha Arogya India Pvt Ltd | Ayurvedic products (“Alpha 11” and “Alpha 21”) | |
04/14/2020 | Earth Angel Oils | Essential oil products | * |
04/15/2020 | The Art Of Cure | Homeopathic drug products | * |
04/16/2020 | Nova Botanix LTD DBA CanaBD | CBD products | * |
04/21/2020 | Copper Touch, LLC | "Sani-Bar GK95” and “Sani-Disc GK95D” | * |
04/21/2020 | DrJockers.com, LLC | Super C, Vitamin D/K2, Zinc Charge, and ImmunoStrong Berry Liquid | |
04/23/2020 | Prefense LLC | Prefense Hand Sanitizers | * |
04/27/2020 | Santiste Labs LLC | “DefendTM Patch” | * |
04/27/2020 | Hopewell Essential Oils | Essential oils and herbal products | * |
05/04/2020 | Honey Colony LLC | "Quicksilver Liposomal Vitamin C w/ Liposomal,” “Jigsaw Magnesium With SRT,” and products labeled to contain silver, including “Silver Excelsior Serum” | * |
05/04/2020 | Dr. Dhole's Sushanti Homeopathy Clinic | “Homeopathic Genus Epidemicus” | * |
05/06/2020 | GlutaGenic | Viral Protection Kits | |
05/06/2020 | Alive By Nature, Inc. | “NAD+” and “NMN” sublingual gel products | * |
05/07/2020 | Sanit Technologies LLC dba Durisan | Non-alcohol based hand sanitizer products | * |
05/07/2020 | AgroTerra, Ltd. dba Patriot Hemp Company | CBD products, silver, iodine, medicinal mushroom, vitamin C, selenium, zinc, vitamin D3, astragalus, and elderberry | * |
05/07/2020 | WashingtonsLastFrontier.Com | Essential oils and dietary supplements | * |
05/07/2020 | Chronic Lyme Treatments | Herbal products, including "COVID-19 Core Formula," "Immunity Blend," and "Protection Blend" | * |
05/08/2020 | Seanjari Preeti Womb Healing, L.L.C. | Honey product, "COVID-19 COUGH Syrup" | * |
05/08/2020 | Plum Dragon Herbs, Inc. | Traditional Chinese medicine (TCM) products | * |
05/11/2020 | Fusion Health and Vitality LLC | "CORE” and “IMMUNE SHOT” | |
05/11/2020 | Center for New Medicine/Perfectly Healthy by Connealy MD | Camu Camu’s Vitamin C, Vitality C, Immunity Kit, Vitamin D3-K2, Liquid Silver, and Power Immune | * |
05/14/2020 | White Eagle Native Herbs | Herbal products | * |
05/14/2020 | benjaminmcevoy.com | Dietary supplements | * |
05/15/2020 | Noetic Nutraceuticals | CBD products | * |
05/15/2020 | The Golden Road Kratom | Kratom products | * |
05/15/2020 | Natural Solutions Foundation | "Dr. Rima RecommendsTM Nano Silver 10 PPM” products | |
05/19/2020 | SpiceTac | Vitamin C product | * |
05/20/2020 | Life Unlearned, LLC | Vitamin D products | * |
05/21/2020 | Apollo Holding LLC | “NoronaPak” products, including cannabidiol (CBD) and other supplement products | * |
05/21/2020 | North Coast Biologics | “nCoV19 spike protein vaccine” | |
05/26/2020 | Careful Cents, LLC | Essential oil products | * |
05/26/2020 | Musthavemom.com | Colloidal silver, vitamins, minerals, herb oils and a homeopathic drug product | * |
05/26/2020 | Alternavita | Grapefruit seed extract, colostrum, and cod liver oil products | * |
05/26/2020 | CBD Gaze | CBD products including Restorative Botanicals Ultra High Strength Hemp Oil Supplement and Serenity Hemp Liquid Dietary Supplement | * |
05/28/2020 | Quadrant Sales & Marketing, Inc. | Non-alcohol based hand sanitizer product | * |
05/28/2020 | StayWell Copper Products | “Germ Stopper” products | * |
06/01/2020 | Dr. Sherrill Sellman | HealthMax Nano-Silver Liquid, Silver Biotics Silver Lozenges with Vitamin C, and Silver Biotics Silver Gel Ultimate Skin & Body Care (collectively, “your silver products”) | |
06/04/2020 | EUCYT Laboratories LLC | Products derived from human umbilical cord blood and umbilical cord, VidaCord™, VidaGel™ and VidaStem™; an exosome product, XOsomes™; and an amniotic fluid derived product, VidaFlo™ | |
06/08/2020 | organic-beauty-recipes.com | Essential oil products | * |
06/10/2020 | www.outoftheboxremedies.com | Iodine products | * |
06/10/2020 | Medakit Ltd | "COVID-19 Rapid Test Kit” (aka “COVID-19 IgM/IgG Rapid Test” and “Covid-19 Fast Test Kit”) | * |
06/15/2020 | antibodiescheck.com | “Antibodies Test Kit for Covid19” (aka “Corona Check Kit,” “Antibodies Check Kit,” “Covid-19 IgG/IgM Rapid Test Cassette (WB/S/P),” and “Corona Antibodies Test” | * |
06/15/2020 | Sonrisa Family Dental dba www.mycovidtest19.com | “Cellex Test Kit” and “Leccurate Test Kit” | * |
06/15/2020 | Sovereign Laboratories, LLC | “PRO Vital C-LD®,” “PRO Colostrum-LD®,” “Vital C-LDTM,” and “Colostrum-LD®” | |
06/15/2020 | FRS International, LLC | Quercetin-containing soft chew and liquid concentrate products | |
06/17/2020 | KBMO Diagnostics, LLC | “COVID-19 Fingerstick Test Kit” | * |
06/17/2020 | Modern Allergy Management LLC dba Direct Med Solutions LLC | "COVID-19 Fingerstick Test Kit" | * |
06/18/2020 | Project 1600 Inc. | Cannabidiol (CBD) products | * |
06/19/2020 | North Isle Wellness Center | Methylene Blue products, including Blu Block | * |
06/25/2020 | Curativa Bay Corporation | Advanced Hypochlorous Skin Spray | * |
06/26/2020 | Nuance Health, LLC | “Swype Shield” | * |
06/26/2020 | SuperHealthGuard and Loyal Great International Ltd. | Lianhua Qingwen Capsule | * |
06/29/2020 | Epro E-Commerce Limited dba DealExtreme and DX.com | “Wondfo Novel Coronavirus (2019-nCoV) Antibody Detection Kit” | * |
06/30/2020 | Center for Wellness and Integrative Medicine | "COVID Supplement Protection Pack” (also referred to as the “COVID Household Value Pack”), Thymosin-Alpha, and Methylene Blue Capsules | * |
07/06/2020 | Shen Clinic, LLC | Traditional Chinese Medicine (TCM) products, including "SHUANG HUANG LIAN" and "Gan Mao Ling" | * |
07/06/2020 | Lianhuaqingwencaps.com | Traditional Chinese medicine (TCM) product, “Lianhua Qingwen” | * |
07/06/2020 | Lotus Herbal Supplements | Traditional Chinese medicine (TCM) product, “Lianhua Qingwen Capsules” | * |
07/06/2020 | Butterfly Expressions LLC | Blessed waters, essential oils, hand sanitizers, homeopathic products, and tinctures | * |
07/06/2020 | SinoTradition.com | Traditional Chinese medicine (TCM) products, including "Lianhua Qingwen Capsules" and "Qing Fei Pai Du Tang" | * |
07/07/2020 | Ionogen, LLC | “Ionopure Skin & Hands” | * |
07/10/2020 | Health Beauty Love | Tincture, “E-Munity" | * |
07/13/2020 | Kegan Wellness | “She Vitamin C Tablets,” “She+ Tablets,” and “Giloe+ Tablets” | * |
07/21/2020 | 21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics2 | Umbilical cord derived stem cell product, Exosome product, Deluxe Immune Support Bundle” (Immune Support Bundle), “Dr. Phillip Yoo D.C.’s Signature – Emergency II COR-1:9 CV-19 Deluxe Immune Boost Protection Kit,” and “Create Wellness Clinics COVID-19 Coronavirus SARS-CoV-2 Antibody At Home Rapid Telemedicine10 Minute Telemedicine Test Kit With Virtual Consultation” | * |
07/23/2020 | AkivaMed Inc. | “COVID-19 Antibody Rapid Test Kit” | * |
07/23/2020 | Holistic Health International, LLC | At-home stool sample collection kit, “SARS-COV-2 STOOL TEST (SCV)” | * |
07/24/2020 | CoreMedica Laboratories, Inc. | At-home sample collection kit, “COVID-19 (SARS-CoV-2) ANTIBODY SCREENING KIT Specimen Self-Collection & Transport Kit” | * |
07/24/2020 | Fair Price Labs, Inc. | At-home sample collection kit | * |
07/30/2020 | Vapore LLC dba Mypurmist | Mypurmist | * |
08/03/2020 | MMSTabs.com | MMS Products | * |
08/06/2020 | Canadian Chaga | "Chaga products" including "124 Chaga Capsules,” “Chaga Tea,” and “Canadian Chaga Tincture” | * |
08/07/2020 | H-Lab Life | “Multi-Use Spray” products | * |
08/10/2020 | Greater Peoria Physical Medicine & Rehabilitation, S.C. d.b.a. Joseph Health Group | Basic Immune Support Kit, Enhanced Immune Support Kit, and Ultra Immune Support Kit | |
08/11/2020 | Oxford Medical Instruments USA, Inc. | Salt inhaler products, including "OMI Salt Therapy Pipes" | * |
08/14/2020 | SilveryGuy | Colloidal Silver | * |
08/17/2020 | Predictive Biotech | CoreCyteTM | |
08/17/2020 | PA Green Wellness LLC dba A Predictive Biotech Certified Facility | CoreCyte™ | * |
08/18/2020 | Pomegranate Consulting, LLC, Pomegranate Consulting, Ltd. dba Glorious One-Pot Meals | “COVID-19 test package” | * |
08/19/2020 | Durazo Medical Biomagnetism | “Biomagnetism Magnetic Therapy DIY Kits” | |
08/19/2020 | Living Senior, LLC | CBD products | * |
08/27/2020 | Lattice Biologics, Ltd. | Amniotic fluid product (sometimes referred to as AmnioBoost) | |
09/01/2020 | 1 Party At A Time | BetterFly, a niacin containing product | * |
09/09/2020 | Pharmacy Plus, Inc. dba Vital Care Compounder | “COVID PACK” and “COVID ‘POSITIVE’ PACK” | * |
09/11/2020 | KetoKerri LLC | “KK Black Seed Oil,” “KK Breakthrough Vitamin D with Chondroitin & Oleic," “Stonebreaker,” “KK EDTA with Selenium and Minerals,” “Zeolite,” “Ultra Liquid Zeolite,” and “DR. FITT FIRE FIGHTERS” | * |
09/22/2020 | Nephron Pharmaceuticals Corporation | ANDA 78202 Budesonide Inhalation Suspension, for inhalation suspension | |
09/29/2020 | Tonic Therapeutic Herb Shop & Elixir Bar | Herbal products | * |
10/05/2020 | Physician 360, Inc. | Physician 360 COVID-19 Rapid Test | |
10/07/2020 | Prairie Dawn Herbs | Herbal products | * |
10/07/2020 | Griffo Botanicals | Herbal tincture products | * |
10/15/2020 | LVWellness & Aesthetics | “COVID-19 ANTIBODY TEST KIT," ViraFend Multi-Virus Defense product | * |
10/16/2020 | For Our Vets LLC dba Patriot Supreme | CBD products | * |
10/23/2020 | Beepothecary LLC | Bee products, including “Elderberry, Honey & Propolis Syrup,” “BEEbread,” and “BEEHive Delight,” | |
10/23/2020 | Peterson Research Laboratories LLC | "Simple Silver” | |
10/23/2020 | Predator Nutrition | Elixir (labeled to contain oxymatrine, berberine, and ecklonia cava), Salidroside, Unbreakable (labeled to contain BPC-157), Vitamin C + Bioflavonoids & Rosehip, Vitamin D3, and Ashwagandha | * |
10/29/2020 | Trask and Roth Inc. dba Trask & Roth Research and Manufacturing | “Lateral Flow Testing Device” | * |
10/30/2020 | Spartan Enterprises Inc. dba Watershed Wellness Center | “Dissolve BioActive Silicate,” and products labeled to contain silver | * |
11/02/2020 | NovaBay Pharmaceuticals, Inc. | ANTIMICROBIAL LID & LASH SOLUTION, PURE HYPOCHLOROUS ACID, 0.01%, 20 m | * |
11/10/2020 | Sage Woman Herbs, Ltd. dba Sage Consulting & Apothecary | X-tra Strength CV Bundle, Golden Mushroom Blend, Golden Mushroom Blend Tincture, Moducare Chewables, Vitamin C with Bioflavonoids, Protocol for Life Balance K2 MK-7 & D3, Sovereign Silver Bio-Active Silver Hydrosol, Super Elderberry Syrup, Respiratory Tonic, Cistus Incanus Tea, Manuka Honey, Respiratory/Head Lungs, Shuang Huang Lian, Winter Rescue, and Winter Rescue Tincture | |
11/17/2020 | Innovative Medicine LLC | “Nadovim” | |
11/17/2020 | ChromaDex | “Tru Niagen products” | |
11/18/2020 | Pro Breath MD, LLC dba Dentist Select and OraCare | “OraCare Health Rinse” and “OraCare Operatory Pre-Rinsing Set” | * |
11/18/2020 | Vibrant Health Care, Inc. | Umbilical cord derived cellular product | * |
11/18/2020 | Red Moon Herbs | American Ginseng Elixir, Ashwagandha, Astragalus, Breathe Clear, Chickweed, Dandelion, Echinacea, Elderberry, Elderberry Elixir, Elecampane, Garlic Elixir, Ginkgo, Hyssop, Kudzu, Lobelia, Lung Support, Mushroom Elixir, Turmeric, Usnea, Violet, Viral Spiral, Wild Cherry Bark Syrup, and Yarrow | * |
11/23/2020 | Industry Lab Diagnostic Partners | “COVID-19 Testing Kit” | * |
11/30/2020 | Avazo-Healthcare, LLC | COVID-19 test kit products and CBD products | |
12/02/2020 | Rat's Army | “VIRUS BIOSHIELD" | * |
12/02/2020 | Health & Wellness Center International One, L.L.C. dba Hotze Vitamins | “Dr. Hotze’s Immune Pak with Vitamins A, B, C, D, Zinc and Probiotics," “Dr. Hotze’s Kids Immune Pak,” and “Dr. Hotze’s Teen Immune Pak” | |
12/02/2020 | Heavenly Natural Products | C60 (Carbon 60) and colloidal silver products, including “AVOCADO C60 ANTI-VIRAL COMBO – VIRUS PREVENTION” | * |
12/07/2020 | Paradigm RE LLC | "Thymosin Alpha 1” | * |
12/10/2020 | iThrive.health | Vitamins, quercetin, zinc and omega-3 products | * |
12/10/2020 | Indigenous Products | Mineral products | * |
12/18/2020 | Rowpar Pharmeceuticals | CloSYS Oral Spray, CloSYS Non-Irritating RINSE UN-flavored for ULTRA SENSITIVE Mouths, and CloSYS Non-Irritating RINSE Mildly Flavored for SENSITIVE Mouths products | * |
12/21/2020 | Riverstone LLC | “Flu Immune Drops,” “L-Lysine,” “Lysine Extra,” and “Monolaurin” | * |
12/21/2020 | Sparrow Health & Performance LLC | Organic Liposomal Vitamin C, Nanoemulsified D3K2, and Immune Support Package (which includes Organic Liposomal Vitamin C, Nanoemulsified D3K2, and Virus Be Gone products, with Smart Silver as an optional add-on) | * |
01/04/2021 | Coco's Holistic Specialties & Apothecary | 4-Thieves Florida Tea Concentrate and 4-Thieves Florida Tea Powder | * |
01/12/2021 | AusarHerbs | “Corona Destroyer Tea” | * |
01/12/2021 | Allimax Us | Allicin capsules, creams, gels, sprays, and liquid products | * |
01/25/2021 | EnMed MicroAnalytics, Inc. | “COVID-19 BLOOD SPOT COLLECTION PACKET” and the “SARS-CoV-2 SALIVA RT-PCR TEST COLLECTION PACKET” | * |
01/25/2021 | PYRLess Group, LLC dba Dr. Fitt | Buffered C Powder, Get Well 2 Day Vit A, Get Well 2 Day Vit D3, Robynzyme, and OMG Cell Protek | |
02/16/2021 | Dr. Paul's Lab | “COVID-Aid Tincture” | * |
02/18/2021 | SafaLab, Inc. | The Prevention 12 Pak (also referred to as the Coronavirus Prevention 12 Pak), consists of the products SOUL, CORE, Cellular Detox, Turb-O2, Vitamin C (Anti-Oxidant Assist), Vitamin D3 (Light Assist), Glutathione, Selenium, Zinc, Vitamin A, Melatonin, and Iod Assist (Iodine) | * |
02/18/2021 | B4B Corp. | Earth Tea Extra Strength | * |
02/18/2021 | Mercola.com, LLC | “Liposomal Vitamin C,” “Liposomal Vitamin D3,” and “Quercetin and Pterostilbene Advanced” | |
02/26/2021 | Orvic dba Webstore-USA | “COVID-19 BLOOD SPOT COLLECTION PACKET” and the “SARS-CoV-2 SALIVA RT-PCR TEST COLLECTION PACKET” | * |
03/01/2021 | Ageless Global, LLC | “Immunoral,” “Immune Plus,” “MD Immune Support Spray,” and “MD CVK-365 Mouth Spray” | |
03/04/2021 | Opgal Optronic Industries Ltd. | “Therm-App MD” and “Therm-App MD Pro” | |
03/04/2021 | Thermavis | “Multi-Person Thermal Screening Camera” | |
03/04/2021 | Thermoteknix System Limited | “FevIR Scan 2” | |
03/04/2021 | Westminster International Ltd | “WG 520” and “WG 620” | |
03/04/2021 | Workswell Group s.r.o. | “MEDICAS” | |
03/04/2021 | CreativeStar Solutions | “Artemis TI-CS-T11 Thermal Scanner” and “Artemis Gateway” | |
03/04/2021 | Omega Engineering Inc. | “TI-120GTS” | |
03/04/2021 | Dubak Electrical Group | “DuThermX” | |
03/04/2021 | Shenzhen Sunell Technology Corporation | Bi-Spectrum Fever Screening Network Camera (SN-T5P-F), Temperature Screening Thermographic Network Bullet Camera (SN-F22-B), AI Fever Screening Network Camera With Integrated Blackbody (SN-T5H-P-F), and Fever Screening Body Temperature Measurement Network Camera Accurate ±0.3℃ (SN-T5/F) | |
03/04/2021 | Omnisense Systems Pte Ltd | Sentry MK4 | |
03/05/2021 | CAMA Wellness Center/IodoRios Company, LLC | Hand wipe product | * |
03/12/2021 | Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials | “AIR PURIFY AROMAMIST,” “HEALER’s CHAI AROMATEA & BREATH DROPS,” “ELEVATION OF MIND AROMAMIST,” and “ROSE FREQUENCY TONGUE TINCTURE” | * |
03/18/2021 | Block Scientific | “QUIKPACII COVID-19 ANTIBODY TEST KIT” and the “Long Island Biotech COVID-19 Antigen Rapid Test (Colloidal Gold)” | |
03/24/2021 | Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs | “COVID-19 IgM/IgG Rapid Test” | |
03/25/2021 | Ikcon Investments, Inc dba Ikcon Medical | “Akcutest COVID-19 Antibody Test” and the “Lumigenik COVID-19 Antigen Rapid Test” | |
04/01/2021 | Natural Adventure, LLC | Purity Sanitizer with 70% Alcohol and Purity Essential Oil Blend products | * |
04/06/2021 | Sethi Laboratories | “Rapid COVID-19 Antibody Self Test Kit” and a “Rapid COVID-19 Antigen Self Test Kit” | |
04/07/2021 | Allure Imports | Silver Soul Immune Support, Silver Soul Body Spray and Vitality C60 | * |
04/07/2021 | About Mineral | Puriton topical skin products | * |
04/13/2021 | Trinity Natural Health & Pain Management, Inc. | “COVID-19 Formula” | * |
04/13/2021 | Anytime COVID Test LLC | “Covid-19 Test Kit” | |
04/13/2021 | Manhattan Stitching Company, Inc. | “KN95 Face Mask”, “3-ply Face Mask”, and “3-Ply Disposable Youth Face Mask” | |
05/04/2021 | Baltimore Beauty Security Square Mall | GenBody COVID-19 Ag test and the GenBody COVID-19 IgM/IgG test | * |
05/06/2021 | Disinfect & Shield | DISINFECT™ & SHIELD HAND SANITIZER | |
05/06/2021 | Covalon Technologies Inc. | non-alcohol based hand sanitizer products | * |
05/19/2021 | BGP, LLC | “BIOCENCE WS Multi-use Selective Antibacterial / Antiviral Human OTC Drug” | |
05/24/2021 | Beauty & Spa Concepts, DBA Beenefits | Brazilian Propolis Extract | |
05/24/2021 | Everything Health LLC | CoronaBox | |
05/27/2021 | OCLO LLC/OCLO Nanotechnology Science | Various chlorine dioxide products, including "OCLO 3000" | * |
06/07/2021 | Amplicon Land, LLC | “QuikPacII COVID-19 IgG/IgM Test” | * |
06/10/2021 | Innova Medical Group, Inc. | SARS-CoV-2 Antigen Rapid Qualitative Test | |
06/22/2021 | Pacific Center of Health/Pacific Center of Health & Acupuncture | Immune Builder, High Risk Environment Pack- NO SYMPTOMS, Anti-Viral Herbal Formula, Anti-Viral Herbal Pack – ACUTE ILLINESS, Kitchen Sink, Lung Formula Dry Cough, Lung Formula Wet Cough, Colloidal Silver and Post COVID-19 Recovery products | * |
07/07/2021 | Halodine, LLC | Halodine nasal and oral “sanitizer” product lines that include the over-the-counter (OTC) drug products, Halodine Nasal Antiseptic Swabstick, Halodine Nasal Antiseptic, Halodine Oral Antiseptic Spray and Halodine Oral Rinse | |
07/09/2021 | USH Diagnostics, Inc./covidinstanttest.net | “Rapid Dual Antibody Test,” “Rapid 10 Minute Antigen Test” and a “Saliva Test Kit” | * |
07/09/2021 | Biopolygen Corp. | “COVIGEN AG-1 Covid-19 Self Detection Kit,” the “COVIDEX AB-1 Covid-19 Self Detection Kit,” and the “COVID-19 Antigen and Antibody Combo Set” | * |
07/20/2021 | Jordan’s Crossing Herbal Connections | “Germaphobe’s Delight Spray” | |
07/26/2021 | Vivera Pharmaceuticals, Inc. | “COVxRDA Saliva Antigen Test” and a “COVx-RDA Nasal Antigen Test” | |
07/26/2021 | Vivera Pharmaceuticals, Inc. | VIVERA + OMECARE Home Specimen Collection Kit | |
07/28/2021 | Dr. Thomas Polucki Upper Cervical Chiropractic, Inc. | Nitric Oxide Support and Melatonin products | |
07/29/2021 | Lepu Medical Technology -Beijing- Co., Ltd. | Neutralization Antibody Test kit (Colloidal Gold, Fluorescent, Elisa), a SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), and a Saliva Antigen Rapid Test | |
08/03/2021 | Blue Willow Biologics | A non-alcohol-based consumer antiseptic nasal product | |
08/10/2021 | Secret of the Islands | Salt scrub products | * |
08/19/2021 | Mahita, LLC dba PushMyCart | “Patanjali Coronil Kit,” “Dr. Reckeweg Arsenic Album Dilution 30 CH,” “SBL Arsenicum Album Dilution 30 CH,” “Kerala Ayurveda Balarishtam,” and “Kottakkal Balarishtam" | * |
08/24/2021 | Invisi Smart Technologies UK LTD | "ISM5 Invisi Smart Mask," "ISM5 Invisi Smart Mask (Black Edition)" and "ISM30 Invisi Smart Mask" | |
09/03/2021 | Databazaar.com | “KN95 Mask” | * |
09/28/2021 | Strategia Project Management, Inc. | Non-alcohol-based topical antiseptic product, microSURE™ | |
12/01/2021 | DermaCare Biosciences, LTD. | Easy Rapid Now COVID-19 Nasal Swab Antigen Test (Colloidal Gold) | |
12/29/2021 | Varigard, LLC | Alcohol-based consumer topical antiseptic products | |
01/03/2022 | Amcyte Pharma, Inc. | Nasitrol | * |
02/17/2022 | Lusys Laboratories, Inc. | COVID-19 IgG/IgM Antibody Test and a COVID-19 Viral Antigen Test | |
02/22/2022 | My Natural Treatment | Thyme, black seed, eucalyptus, rosemary and peppermint oil products | * |
03/10/2022 | Soda Pharm | “Cold/Flu/COVID Pack,” “Cold and Congestion Loose Leaf Tea,” “Goldenseal Extract,” “Cool Down Loose Leaf Tea,” “Resistance Extract,” “Ache Ease Herbal Drink Syrup,” “Pain Release Extract,” “Headache Blend Extract,” “Vapor Balm,” and the “Mustard Plaster” products | |
03/15/2022 | Iotech International, LLC | “ioRinse” (also referred to as “ioRinse™ RTU”) and “ioCleanse Molecular iodine Hand Cleanser” |
An asterisk (*) under the table column "Corrective Status” indicates the firm’s listed product(s) are no longer sold for the prevention, treatment, mitigation, diagnosis or cure of coronavirus disease 2019 (COVID-19). This status only concerns sale of the listed product(s) for the prevention, treatment, mitigation, diagnosis or cure of coronavirus disease 2019 (COVID-19) and in no way indicates whether the listed products otherwise comply with the laws and regulations enforced by FDA. FDA will monitor all listed firms for recurrence of the conduct cited in the warning letters.