Health Fraud Product Database
This list includes unapproved products that have been subject to FDA health fraud* related violations. These products have been cited in warning letters, online advisory letters, recalls, public notifications, and press announcements for issues varying from products marketed as dietary supplements claiming to cure, mitigate, treat or prevent disease, to the use of undeclared ingredients or new dietary ingredients.
This list only includes a small fraction of the potentially hazardous products marketed to consumers online and in retail establishments. Even if a product is not included in this list, consumers should exercise caution before using certain products.
For more information, see the Medication Health Fraud and Health Fraud Scams webpages.
Search Database
(Table results update automatically as you type)
| Date | Product1 | Firm | Firm Address | Source/URL(s) | Subject | Action | Program Area(s) | Additional Outcome |
|---|---|---|---|---|---|---|---|---|
| 11/27/2024 | LipoFit Turbo | n/a | n/a | n/a | Undeclared sibutramine, metformin, fluoxetine, and furosemide | Public Notification | Drugs | |
| 11/22/2024 | THERMO SHOCK | n/a | n/a | scilabsnutrition.com | Undeclared 1,3-dimethylamylamine (1,3-DMAA) | Public Notification | Foods | |
| 11/22/2024 | Force Forever | n/a | n/a | gnmart.com | Undeclared diclofenac and dexamethasone | Public Notification | Drugs | |
| 11/19/2024 | HON-E-LING | n/a | n/a | Examination of imported goods | Undeclared sibutramine and sildenafil | Public Notification | Drugs | |
| 11/19/2024 | Umary | MXBBB | n/a | amazon.com | Undeclared diclofenac and omeprazole | Recall | Drugs | |
| 11/08/2024 | VITAFER-L Gold 10ml | n/a | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 11/08/2024 | VITAFER-L Gold 20ml | n/a | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 11/08/2024 | VITAFER-L Gold 500ml | n/a | n/a | amazon.com; www.walmart.com | Undeclared tadalafil | Public Notification | Drugs | |
| 11/06/2024 | PeakMax Capsules | VitalityVita | Sacramento, CA | vitalityvita.com | Undeclared sildenafil and diclofenac | Recall | Drugs | Public Notification |
| 11/06/2024 | VitalityXtra Capsules | VitalityVita | Sacramento, CA | vitalityvita.com | Undeclared sildenafil | Recall | Drugs | Public Notification |
| 11/04/2024 | ZapMax Capsules | Boulla LLC | Sacramento, CA | amazon.com | Undeclared sildenafil and diclofenac | Recall | Drugs | Public Notification |
| 11/04/2024 | ZoomMax Capsules | Boulla LLC | Sacramento, CA | amazon.com | Undeclared sildenafil and diclofenac | Recall | Drugs | Public Notification |
| 10/30/2024 | Nhan Sam Tuyet Lien Truy Phong Hoan | n/a | n/a | buy-herbal.com | Undeclared chlorpheniramine, dexamethasone and furosemide | Public Notification | Drugs | |
| 10/30/2024 | ITCHA XS | n/a | n/a | Examination of international mail shipments | Undeclared fluoxetine or bupropion | Public Notification | Drugs | |
| 10/30/2024 | OneMultivitaminic GAF-Plus Advance | n/a | n/a | lipoblueadvance.com | Undeclared dexamethasone, acetaminophen, and aspartame | Public Notification | Drugs | |
| 10/30/2024 | Skin-Cap aerosol spray products | Chemigroup France, formerly known as Cheminova Laboratories | n/a | skincap.com; amazon.com; walmart.com | Undeclared high-potency glucocorticosteroid | Drug Alert | Drugs | |
| 10/07/2024 | Trinity Gold | n/a | n/a | trinitygoldnutrition.com | Undeclared acetaminophen, diclofenac and phenylbutazone | Public Notification | Drugs | |
| 10/02/2024 | Body Shape Weight Loss System | n/a | n/a | Examination of international mail shipments | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs | |
| 09/26/2024 | Ácido Hialurónico | n/a | n/a | ebay.com | Undeclared diclofenac | Public Notification | Drugs | |
| 09/11/2024 | AK Forte | C&A Naturistics | National City, CA | ebay.com, etsy.com | Undeclared acetaminophen and diclofenac | Public Notification | Drugs | Recall |
| 09/05/2024 | Amazy | n/a | n/a | various websites, including SoloVital, Main Products and Amazon, and in some retail stores | Undeclared diclofenac and omeprazole | Drug Alert | Drugs | Public Notification |
| 07/30/2024 | RMSOL GRACIAN | n/a | n/a | botanical-be.com | Undeclared diclofenac | Public Notification | Drugs | |
| 07/30/2024 | SILI PHARMA | n/a | n/a | botanical-be.com | Undeclared diclofenac | Public Notification | Drugs | |
| 07/26/2024 | Optimized Plant Mediated Solutions (OPMS) Black Liquid Kratom | n/a | n/a | n/a | Product label indicates the presence of kratom alkaloids, mitragynine and 7-hydroxymitragynine (7-OH mitragynine) | Safety Alert | Foods | |
| 07/10/2024 | Vail-Bon Jie Yang Wan | n/a | n/a | everymarket.com | Undeclared dexamethasone and chlorpheniramine | Public Notification | Drugs | |
| 07/10/2024 | Gold Hard Steel Plus | Supercore Products Group | Atlanta, GA | hardsteelusa.com | Undeclared sildenafil | Public Notification | Drugs | Recall |
| 07/05/2024 | Hard Steel | Supercore Products Group | Atlanta, GA | hardsteelusa.com | Undeclared sildenafil and acetaminophen | Public Notification | Drugs | Recall |
| 06/28/2024 | Diamond Shruumz | Prophet Premium Blends | Santa Ana, CA | diamondshruumz.com | Products contain Muscimol | Recall | Foods | Investigation of Illnesses |
| 06/20/2024 | Infla-650 | Guru Inc. | Lilburn, GA | nutraherbusa.com; nutra650.com | Undeclared acetaminophen, diclofenac and phenylbutazone | Public Notification | Drugs | Recall |
| 06/14/2024 | Umary | n/a | n/a | solovital.com; Main Products, Inc. | Undeclared diclofenac and omeprazole | Public Notification | Drugs | |
| 06/14/2024 | La Paix | n/a | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs | |
| 04/17/2024 | Ossos-Sans | n/a | n/a | https://alnaturaleshop.com | Undeclared diclofenac and methocarbamol | Public Notification | Drugs | Warning Letter |
| 04/05/2024 | Eva Nutrition Mexican Tejocote root | Global Mix, Inc. | New York | etsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.com | Contains undeclared yellow oleander | Recall | Foods | |
| 04/05/2024 | Science of Alpha Mexican Tejocote root | Global Mix, Inc. | New York | etsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.com | Contains undeclared yellow oleander | Recall | Foods | |
| 04/05/2024 | NWL Nutra Mexican Tejocote root | Global Mix, Inc. | New York | etsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.com | Contains undeclared yellow oleander | Recall | Foods | |
| 04/05/2024 | Niwali Mexican Tejocote root | Global Mix, Inc. | New York | etsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.com | Contains undeclared yellow oleander | Recall | Foods | |
| 04/04/2024 | Elv Control Herbal Supplement | World Green Nutrition, Inc. | n/a | n/a | Contains undeclared yellow oleander | Recall | Foods | |
| 02/29/2024 | SNAKE BONES Anti-Rheumatic Capsules | n/a | n/a | n/a | Undeclared piroxicam | Public Notification | Drugs | |
| 02/29/2024 | QUICK Rheumatism Capsule, Tiger Wang Biaod | n/a | n/a | n/a | Undeclared piroxicam | Public Notification | Drugs | |
| 01/30/2024 | Arize | Today the World | n/a | getarize.com | Undeclared nortadalafil | Public Notification | Drugs | |
| 01/30/2024 | Schwinng | Today the World; STOP CLOPEZ CORP | n/a | schwinnng.com; amazon.com | Undeclared nortadalafil | Public Notification | Drugs | |
| 01/30/2024 | Sustain® | Today the World | n/a | sustainformula.com; amazon.com | Undeclared tadalafil and avanafil | Public Notification | Drugs | |
| 01/26/2024 | nwl NUTRA Mexican Tejocote Root | n/a | n/a | amazon.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | EVA NUTRITION Mexican Tejocote Root | Global Mix Inc. | n/a | eva-nutrition.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | ELV King All Natural Tejocote Root | Sunset Sales + | n/a | amazon.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | ELV King Tejocote Root Raiz de Tejocote | Sunset Sales + | n/a | amazon.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | ALIPOTEC Tejocote Root Dietary Supplement Pieces | ALIPOTEC RAIZ DE TEJOCOTE | n/a | alipotectejocote.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | Science of ALPHA Mexican Tejocote Root | Natural Supplements, LLC | n/a | tejocotemexican.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | H & Natural Tejo Root Raiz de Tejocote | H and Natural | n/a | handnatural.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | H & Natural Brazil Seed | H and Natural | n/a | handnatural.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | ALIPOTEC Tejocote Root Raiz de Tejocote | Backstage CTC Seller | n/a | amazon.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | ALIPOTEC Tejocote Root Dietary Supplement Pieces | n/a | n/a | amazon.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | Nutraholics ELV Tejocote Root Dietary Supplement Pieces | n/a | n/a | amazon.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | Nutraholics ELV Nutraking Mexican Tejocote Root Supplement Pieces | n/a | n/a | amazon.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | ALIPOTEC Tejocote Root | n/a | n/a | amazon.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | Niwali Raiz de Tejocote | Global Mix, Inc. | n/a | etsy.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | Science of Alpha Mexican Tejocote Root | Global Mix, Inc. | n/a | etsy.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | ALIPOTEC Tejocote Root Dietary Supplement Pieces | Innovacion Natural, LLC | n/a | innovacionnatural.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | Tejocotex Tejocote Root | Pastor-Villareal, Inc. | n/a | amazon.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/26/2024 | ALIPOTEC ELV Mexican Tejocote Root | Alipotec South TX; World Green Nutrition, Inc. | n/a | alipotecus.com | Contains undeclared yellow oleander | Alert | Foods | |
| 01/12/2024 | ELV Alipotec Mexican Tejocote Root Supplement Pieces | World Green Nutrition, Inc. | n/a | n/a | Contains undeclared yellow oleander | Recall | Foods | |
| 01/05/2024 | Blue Boy Herb Co. products, including Arthritis Formula, Blood Tonic, Diabecon, Brain Tonic, Gout Formula, Gravel Formula, Heart Tonic, Liver Tonic, Lung Tonic, Oats +, Poke Root Formula, Poke Root Salve, Pressex, Rumalaya, Sacred Meditation Oil, Turmeric Tincture, and Uterine | Blue Boy Herb Company | 10060 Road 263 Carriere, MS 39426 |
https://blueboyherbs.com | New Drug | Online Advisory Letter | Foods; Drugs | |
| 01/02/2024 | ENDUREA | n/a | n/a | amazon.com | Undeclared tadalafil and sildenafil | Public Notification | Drugs | |
| 01/02/2024 | ForeverMen | n/a | n/a | amazon.com | Undeclared sildenafil | Public Notification | Drugs | Recall |
| 01/02/2024 | Seraphim Z | n/a | n/a | amazon.com | Undeclared sildenafil | Public Notification | Drugs | |
| 12/26/2023 | Wild Bull | n/a | n/a | amazon.com | Undeclared nortadalafil | Public Notification | Drugs | |
| 12/26/2023 | TO THE MOON | n/a | n/a | amazon.com | Undeclared sildenafil | Public Notification | Drugs | Recall |
| 12/26/2023 | T XTRA Strength Test Booster | n/a | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/26/2023 | Ram It | n/a | n/a | amazon.com | Undeclared sildenafil | Public Notification | Drugs | Recall |
| 12/21/2023 | Govvi WOW! | n/a | n/a | ebay.com | Undeclared 1,4-dimethylamylamine (DMAA) | Public Notification | Foods | |
| 11/29/2023 | Magnum XXL 9980 | Meta Herbal | E. Hampton, NY | amazon.com | Undeclared sildenafil | Recall | Drugs |
|
| 11/21/2023 | Neptune's Fix | n/a | n/a | n/a | Contains tianeptine | Alert | Drugs |
|
| 11/17/2023 | Himalayan Pain Relief Tea | WS Global, Inc | Brooklyn, NY | himalayan-painrelieftea.com | Undeclared diclofenac and dexamethasone | Public Notification | Drugs | |
| 11/17/2023 | Tepee Herbal Tea | n/a | n/a | amazon.com | Undeclared piroxicam | Public Notification | Drugs |
|
| 11/17/2023 | Notoginseng Formula Special Gout Granule | 8th Avenue Pharmacy | n/a | ebay.com | Undeclared dexamethasone and diclofenac | Public Notification | Drugs | |
| 11/03/2023 | Dr. Ergin's SugarMD Advanced Glucose Support | n/a | n/a | sugarmds.com | Undeclared Glyburide and Metformin | Public Notification | Drugs | |
| 10/19/2023 | The Rock | Noah’s Wholesale, LLC | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs | |
| 09/29/2023 | Reumo Flex | n/a | n/a | botanical-be.com | Undeclared diclofenac | Public Notification | Drugs | |
| 09/29/2023 | Kuka Flex Forte | n/a | n/a | botanical-be.com | Undeclared diclofenac | Public Notification | Drugs | |
| 08/31/2023 | Tapee Tea | n/a | n/a | tapeetea.com | Undeclared dexamethasone and piroxicam | Public Notification | Drugs |
|
| 08/22/2023 | BIG GUYS Male Energy Supplement | n/a | n/a | amazon.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 08/22/2023 | Mens Maximum Energy Supplement | n/a | n/a | amazon.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 08/22/2023 | Round 2 | n/a | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 08/22/2023 | Genergy | n/a | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 08/22/2023 | WeFun | n/a | n/a | amazon.com; eshoponlineusa.com | Undeclared sildenafil | Public Notification | Drugs | |
| 08/22/2023 | X MAX Triple Shot Energy Honey | n/a | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 08/09/2023 | Vegetal Vigra 200mg | n/a | n/a | APG Seven, Inc. | Undeclared sildenafil | Public Notification | Drugs |
|
| 05/17/2023 | AnnieCare Natural Repair Vaginal Capsules | Presilky dba Burhealthy.com | n/a | https://burhealthy.com | New drugs | Online Advisory Letter | Foods; Drugs | |
| 05/08/2023 | New Fast-Act Rheumatism Capsule | n/a | n/a | Various | Undeclared indomethacin | Public Notification | Drugs |
|
| 05/08/2023 | UA-Block | n/a | n/a | Various | Undeclared indomethacin | Public Notification | Drugs |
|
| 05/05/2023 | Platinum 69000 Rhino 69 | n/a | n/a | Various | Undeclared sildenafil | Public Notification | Drugs |
|
| 05/05/2023 | Power Plus Desire | n/a | n/a | Various | Undeclared sildenafil | Public Notification | Drugs |
|
| 05/05/2023 | Rhino 7S Type F3 7000 | n/a | n/a | Various | Undeclared sildenafil and acetaminophen | Public Notification | Drugs |
|
| 05/05/2023 | Phentamene XT | n/a | n/a | Various | Undeclared DMAA | Public Notification | Foods |
|
| 05/11/2023 | V=GRA GOLD 500mg | n/a | n/a | Various | Undeclared sildenafil | Public Notification | Drugs |
|
| 05/08/2023 | Fast-Act Rheuma Capsule | n/a | n/a | Various | Undeclared prednisone-21-acetate and piroxicam | Public Notification | Drugs |
|
| 05/04/2023 | Hard Steel 300K | n/a | n/a | Various | Undeclared tadalafil | Public Notification | Drugs |
|
| 05/04/2023 | Diamond Girl Lite | n/a | n/a | Various | Undeclared sildenafil | Public Notification | Drugs |
|
| 05/04/2023 | Special Edition Platinum 10K | n/a | n/a | Various | Undeclared tadalafil and vardenafil | Public Notification | Drugs |
|
| 05/01/2023 | NORF 20 | n/a | n/a | International Mail Shipments | Undeclared acetaminophen, salicylic acid, and theophylline | Public Notification | Drugs |
|
| 04/19/2023 | DYNAMITE Male Sexual Enhancement | n/a | n/a | gearisle.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 04/19/2023 | NUX Male Sexual Enhancement | n/a | n/a | gearisle.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 04/19/2023 | Pro Power Knight Plus 2550mg | n/a | n/a | gearisle.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 04/13/2023 | AK Forte | n/a | n/a | suprimoimports.com | Undeclared diclofenac, dexamethasone, and methocarbamol | Public Notification | Drugs |
|
| 04/07/2023 | Tantra Jelly Herbal Jelly for Him | n/a | n/a | International Mail Shipments | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 04/07/2023 | American Bangster Black Label Optimum Formula 4000 | n/a | n/a | americanbangster.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 04/07/2023 | American Bangster Optimum Formula 3000 | n/a | n/a | americanbangster.com | Undeclared tadalafil and sildenafil | Public Notification | Drugs |
|
| 04/07/2023 | NORF 20 | n/a | n/a | International Mail Shipments | Undeclared acetaminophen, salicylic acid, and theophylline | Public Notification | Drugs |
|
| 02/08/2023 | Alfia Weight Loss Capsules | n/a | n/a | alfia.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 02/07/2023 | PrimeZen Black 6000 | n/a | n/a | voltcandy.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 02/02/2023 | MANNERS Energy Boost | n/a | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 12/21/2022 | B.B. Clear Dark Spot Remover Cream | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | Amos Make Me White in 7 Days | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | African Queen Strong Bleaching Treatment | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | Light & Natural CAROTONE Black Spot Corrector CREME B.S.C | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | HIYADY Glutatione Cream White & Bright | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | Aneeza Gold Beauty Face Cream | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | Collagen Plus - Vit E Cream, Night Cream | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | Skin care & Cosmetic MSII Express Peeling | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | Skin care & Cosmetic MSII Whitening Peeling | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | Ling Zhi BB Whitening Cream | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | La Tia Mana Crema Limpiadora y Curativa | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | Be Be Special Cream | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | Be Be Special Cream CCM/Yellow | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | CCM Perfect 365 White Cream | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 12/21/2022 | CCM Special Cream Turmeric | n/a | n/a | Various | Skin Product with Mercury and/or Hydroquinone | Public Notification | Cosmetics/Drugs |
|
| 11/21/2022 | JACK'D Sexual Enhancement Liquid | n/a | n/a | Various | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/21/2022 | JACK'D Sexual Enhancement Capsules | n/a | n/a | Various | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/14/2022 | Arterosil | Calroy Health Sciences, LLC | 14362 N Frank Lloyd Wright, Suite 1000 Scottsdale, AZ 85260 | arterosil.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 11/14/2022 | CoQ10 Ubiquinol | Anabolic Laboratories Inc | 26021 Commercentre Dr. Lake Forest, CA 92630-8853 | anaboliclabs.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 11/14/2022 | PrimePolicosanol Microtabs | Anabolic Laboratories Inc | 26021 Commercentre Dr. Lake Forest, CA 92630-8853 | anaboliclabs.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 11/14/2022 | BPS-5 | Healthy Trends Worldwide, LLC | 11011 Spring Point Cir Riverview, FL 33579-4303 | goldenafter50.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 11/14/2022 | Blood Pressure Support | Chambers' Apothecary | 278 Lincoln Way, East Chambersburg, PA 17201 | chambersapothecary.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 11/14/2022 | CoEnzyme Q10 products | Chambers' Apothecary | 278 Lincoln Way, East Chambersburg, PA 17201 | chambersapothecary.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 11/14/2022 | iwi Cholesterol | iwi | 2800 Post Oak Blvd Suite 5858 Houston, TX 77056 | iwilife.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 11/14/2022 | Cholesterol Command | BergaMet North America LLC | 6445 S. Tenaya Way Suite B110 Las Vegas, NV 89113-1989 | bergametna.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 11/14/2022 | CholestAid | Essential Elements | 675 N. 2800 W #101 Lindon, UT 84042 | essentialelementsnutrition.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/28/2022 | Wonder Pill Capsules | Proper Trade LLC/My Stellar Lifestyle | n/a | amazon.com; walmart.com | Undeclared tadalafil | Recall | Drugs |
|
| 08/02/2022 | SANGTER Energy Supplement, 3000mg | Distributor RFR, LLC | Miami, FL | sangter.com and retail stores | Undeclared sildenafil | Recall | Drugs |
Public Notification |
| 07/28/2022 | Honeymoon Exclusive For Men & Women | n/a | n/a | Examination of imported goods | Undeclared tadalafil and sildenafil | Public Notification | Drugs |
|
| 07/25/2022 | Sustango | Ultra Supplement LLC | Wilmington, DE | amazon.com | Undeclared tadalafil | Recall | Drugs |
|
| 07/22/2022 | Lipopastilla + Gold Max | n/a | n/a | lipopastillas.com | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 07/15/2022 | Adam's Secret Extra Strength Blue | n/a | n/a | adamssecret.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 07/15/2022 | Adam's Secret Extra Strength Purple | n/a | n/a | adamssecret.com | Undeclared tadalafil and sildenafil | Public Notification | Drugs |
|
| 07/15/2022 | Adam's Secret Extra Strength Amazing Black | n/a | n/a | adamssecret.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 07/15/2022 | Adam's Secret Extra Strength 300 Platinum (White Packaging) | n/a | n/a | adamssecret.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 06/27/2022 | Launch Sequence Capsules | Loud Muscle Science, LLC | n/a | amazon.com, amazon.ca, ebay.com, and retail stores | Undeclared tadalafil | Recall | Drugs |
|
| 06/27/2022 | Launch Sequence Euphoria Capsules | Loud Muscle Science, LLC | n/a | amazon.com, amazon.ca, ebay.com, and retail stores | Undeclared tadalafil | Recall | Drugs |
|
| 06/27/2022 | Launch Sequence Aphrodisia Capsules | Loud Muscle Science, LLC | n/a | amazon.com, amazon.ca, ebay.com, and retail stores | Undeclared tadalafil | Recall | Drugs |
|
| 04/25/2022 | Kingdom Honey Royal Honey VIP | Shopaax.com | 2 Burleigh Ct., Newark, DE 19702 | shopaax.com | Undeclared sildenafil | Public Notification | Drugs | |
| 04/25/2022 | Cougar Secret Honey VIP | n/a | n/a | greenvalleyshops.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 04/25/2022 | Medcare Golden Royal Honey | n/a | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 04/25/2022 | HoneyGizer™ | n/a | n/a | amazon.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 04/25/2022 | ETUMAX VIP Royal Honey for Him | n/a | n/a | honeyworldusa.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 04/25/2022 | Erkexin | n/a | n/a | aliexpress.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 04/25/2022 | Royal Honey VIP | Thirsty Run LLC / US Royal Honey LLC | 6841 Ternes St. Dearborn, MI 4812 | thirstyrun.com; usroyalhoney.com | Undeclared tadalafil | Public Notification | Drugs | |
| 04/25/2022 | Secret Miracle Honey (for Women) | n/a | n/a | usroyalhoney.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 04/25/2022 | Secret Miracle Honey (for Men) | n/a | n/a | etsy.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 04/25/2022 | Vital Honey | MKS Enterprise, LLC | 59 Paulison Ave. #13 Passaic, NJ 0705 | wholesaleonline1.com; thirstyrun.com | Undeclared tadalafil | Public Notification | Drugs | |
| 04/25/2022 | Helmi's Honey VIP | n/a | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 04/25/2022 | X Rated Honey for Men | 1am USA Incorporated dba Pleasure Products USA | 6603 Crimson Lane Barnhart, MO 63012 | pleasureproductsusa.com; amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 04/20/2022 | Ortiga Mas Ajo Rey Extra Forte | n/a | n/a | ebay.com | Undeclared diclofenac, dexamethasone and methocarbamol | Public Notification | Drugs | |
| 04/20/2022 | Ortiga Mas Ajo Rey | n/a | n/a | amazon.com | Undeclared diclofenac | Public Notification | Drugs | |
| 04/20/2022 | Artri King | n/a | n/a | amazon.com, latinfoodsmarket.com, walmart.com | Undeclared dexamethasone and diclofenac | Public Notification | Drugs | |
| 03/04/2022 | Wonderful Honey | n/a | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/10/2022 | Rise Up Red Edition Capsules | Positive-Health | n/a | amazon.com | Undeclared tadalafil | Recall | Drugs |
|
| 02/09/2022 | Red Mammoth capsules | Celebrate Today | n/a | amazon.com | Undeclared tadalafil and sildenafil | Recall | Drugs |
|
| 02/08/2022 | The Red Pill | Your Favorite Shop | n/a | amazon.com | Undeclared tadalafil | Recall | Drugs |
|
| 02/08/2022 | MAC DADDY PURPLE capsules | ABC SALES 1 INC | n/a | amazon.com | Undeclared tadalafil | Recall | Drugs |
|
| 02/08/2022 | MAC DADDY RED capsules | ABC SALES 1 INC | n/a | amazon.com | Undeclared tadalafil and sildenafil | Recall | Drugs |
|
| 02/04/2022 | MegMan Performance Booster capsules | Junp LLC | n/a | amazon.com | Undeclared tadalafil | Recall | Drugs |
|
| 01/28/2022 | Hard Dawn Rise and Shine capsules | Esupplementsales, LLC | n/a | amazon.com | Undeclared tadalafil | Recall | Drugs |
|
| 01/07/2022 | Taewon Liar | Various Distributors | n/a | etsy.com | Undeclared meloxicam | Public Notification | Drugs |
|
| 01/05/2022 | Artri Ajo King | Various Distributors | n/a | amazon.com | Undeclared diclofenac | Public Notification | Drugs |
|
| 01/02/2022 | Nasitrol | Amcyte Pharma, Inc. | 5400 Carillon Point, Kirkland, WA 98004 | nasitrol.com | Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 12/08/2021 | Avaphinal | Various Distributors | n/a | walmart.com | Undeclared sildenafil | Public Notification | Drugs | |
| 12/08/2021 | Brahma Male Enhancement | Various Distributors | n/a | walmart.com | Undeclared sildenafil | Public Notification | Drugs | |
| 12/08/2021 | Hard AF! | Various Distributors | n/a | walmart.com | Undeclared sildenafil and acetaminophen | Public Notification | Drugs | |
| 12/08/2021 | Helmi’s Honey VIP | Various Distributors | n/a | walmart.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/08/2021 | Jaguar Power | Various Distributors | n/a | walmart.com | Undeclared sildenafil | Public Notification | Drugs | |
| 12/08/2021 | Kangaroo Intense Alpha 3000 | Various Distributors | n/a | walmart.com | Undeclared sildenafil | Public Notification | Drugs | |
| 12/08/2021 | Magnum XXL 9800 | Various Distributors | n/a | walmart.com | Undeclared sildenafil | Public Notification | Drugs | |
| 12/08/2021 | Pink Pussycat | Various Distributors | n/a | walmart.com | Undeclared sildenafil | Public Notification | Drugs | |
| 12/08/2021 | Go On Red | Various Distributors | n/a | walmart.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/01/2021 | “VitaStik” product line | VitaStik, Inc. | 433 N. Camden Dr. #600, Beverly Hills, CA 90210 | vitastik.com | Unapproved New Drugs/Misbranded | Warning Letter | Drugs | |
| 12/01/2021 | “VitaCig products” | VitaCig, Inc. | 2375 Watermill Dr., Orange Park, FL 32073 | vitaciggroup.com | Unapproved New Drugs/Misbranded | Warning Letter | Drugs | |
| 12/01/2021 | “vaporizer” and “diffuser” products | NV Nutrition, LLC | 4700 140th Ave N. Suite 112, Clearwater, FL 33762 | nutriair.com | Unapproved New Drugs/Misbranded | Warning Letter | Drugs | |
| 12/01/2021 | “B12 VITAMINVAPE” | Vitamin Vape, Inc. | 6320 S. Sandhill Road, Suite 5, Las Vegas, NV 89120 | vitaminvape.co | Unapproved New Drugs/Misbranded | Warning Letter | Drugs | |
| 12/01/2021 | “Caffeine Pen” | Eagle Energy USA, Inc. | 27 N. 27th Street, Suite 2102, Billings, MT 59101-2347 | eagle.energy | Unapproved New Drugs/Misbranded | Warning Letter | Drugs | |
| 11/18/2021 | Crocin products | Saffron Health Sciences | 13 Dexter Rd, E Brunswick, NJ 08816 | saffronhealthsci.com; facebook.com/saffronhealthsci/; amazon.com; | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/28/2021 | Non-alcohol-based topical antiseptic product, microSURE™ | Strategia Project Management, Inc. | 1000 Jorie Blvd. Suite 370 Oak Brook, IL 60523 | microsure.com; twitter.com/microsure_; facebook.com/microSURE.HandSanitizer | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 09/22/2021 | Arsyn | Supplement Science Corp. d/b/a Condemned Labz | 2139 East 3rd Street Brooklyn, NY 11223 | condemnedlabz.com/; facebook.com/condemnedlabzofficial | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/22/2021 | ConvictStim | Supplement Science Corp. d/b/a Condemned Labz | 2139 East 3rd Street Brooklyn, NY 11223 | condemnedlabz.com/; facebook.com/condemnedlabzofficial | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/22/2021 | Humaslin | Supplement Science Corp. d/b/a Condemned Labz | 2139 East 3rd Street Brooklyn, NY 11223 | condemnedlabz.com/; facebook.com/condemnedlabzofficial | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/22/2021 | Thyrogenic | Supplement Science Corp. d/b/a Condemned Labz | 2139 East 3rd Street Brooklyn, NY 11223 | condemnedlabz.com/; facebook.com/condemnedlabzofficial | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/22/2021 | DNA Dispatch | Supplement Science Corp. d/b/a Condemned Labz | 2139 East 3rd Street Brooklyn, NY 11223 | condemnedlabz.com/; facebook.com/condemnedlabzofficial | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “Glyco-Well” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “Pan-Gest” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “Heart-Line” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “Aspara-Can” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “Cherry Gold” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “H.H.S. Formula” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “Brain Balance” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “Passionate Pursuit” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “Better Mood” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “Male Prosexual” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “Ear Well” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “Pink Lady” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | “Eye-C” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/10/2021 | Hemorr-Norm” | Holographic Health, Inc. | 516 E. Market Street Kingsport, TN 37660 | holographichealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | “Black Indian Salve,” also referred to as “Indian Herb,” “X,” and “Black Salve” | McDaniel Water LLC | 363 Ricketson Road Amistad, NM 88410 | mcdanielwater.com | Unapproved New Drugs/Misbranded | Warning Letter | Drugs |
|
| 09/07/2021 | CuraLin | Radhanite, LLC d/b/a Curalife Ltd | 208 Paterson Plank Rd. Union City, NJ 07087-2826 | curalife.com/; instagram.com/curalife/ and https://www.facebook.com/curalife/ | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | Sugar Balance | Aceva, LLC | 624 West Glen Ave. Peoria, IL 61614 | aceva.com/; twitter.com/acevahealth and https://www.facebook.com/acevanutrition | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | Diabetes Support | Ar-Rahman Pharm LLC | 14625 Baltimore Ave., Suite 885 Laurel, MD 20707 | ar‐rahmahpharm.com/; instagram.com/arrahmahpharm/; facebook.com/ArRahmahPharm | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | “Lysulin Weight Loss Shake” | Lysulin, Inc. | 4930 Bradshaw Ct. San Diego, CA 92130 | lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagement | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | “Lysulin Diabetes and Prediabetes Chewables” | Lysulin, Inc. | 4930 Bradshaw Ct. San Diego, CA 92130 | lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagement | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | “Lysulin Diabetes and Prediabetes Liquid” | Lysulin, Inc. | 4930 Bradshaw Ct. San Diego, CA 92130 | lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagement | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | “Lysulin Diabetes and Prediabetes Capsules” | Lysulin, Inc. | 4930 Bradshaw Ct. San Diego, CA 92130 | lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagement | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | “Lysulin Diabetes and Prediabetes Powder” | Lysulin, Inc. | 4930 Bradshaw Ct. San Diego, CA 92130 | lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagement | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | “Berry Gen Sugar Control” | Live Good Inc. | 860 NW 27th St. Suite 051-51425 Miami, FL 33122 | berrygen.com/; facebook.com/ColagenoBerryGenRestore/; instagram.com/berrygenrestore/ | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | "GLUCOTYPE2” | Phytag Labs | 12600 Hill Country Boulevard Suite R-275 Bee Cave, TX 78738 | phytagelaboratories.com; amazon.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | “Diabetic Support Formula” | Nuturna International LLC | 390 North Orange Ave. Suite 2300 Orlando, FL 32801 | nuturna.com; amazon.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | “Diabetes Doctor Pre-Diabetes” | Pharmaganics LLC | 8475 Parley Lake Rd Waconia, MN 55387 | diabetesdoctor.com; facebook.com/naturaldiabetesdoctor; instagram.com/diabetesdoctor/ | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | “Diabetes Doctor Blood Sugar 24 Hour” | Pharmaganics LLC | 8475 Parley Lake Rd Waconia, MN 55387 | diabetesdoctor.com; facebook.com/naturaldiabetesdoctor; instagram.com/diabetesdoctor/ | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | DiabetesSupport | Metamune Inc | 8001 S 194th St. Kent, WA 98032-1126 | bodymune.com/; facebook.com/Bodymune/; amazon.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 09/07/2021 | Diabalance Diabetes Supplement | Holistic Healer & Wellness Center, Inc. | 3998 Clippert St. P.O. Box 23017 Dearborn, MI 48123 | holistichealeronline.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 08/31/2021 | Muscle Test | New York Nutrition Company / American Metabolix | 1083 FM 812 Unit B Cedar Creek, TX 78612-3689 | americanmetabolix.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 08/31/2021 | Banish | New York Nutrition Company / American Metabolix | 1083 FM 812 Unit B Cedar Creek, TX 78612-3689 | americanmetabolix.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 08/31/2021 | Ketogenic Diet Aid | New York Nutrition Company / American Metabolix | 1083 FM 812 Unit B Cedar Creek, TX 78612-3689 | americanmetabolix.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 08/31/2021 | Keto Friendly Collagen | New York Nutrition Company / American Metabolix | 1083 FM 812 Unit B Cedar Creek, TX 78612-3689 | americanmetabolix.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 08/31/2021 | Exile Euphoric Weight Loss | New York Nutrition Company / American Metabolix | 1083 FM 812 Unit B Cedar Creek, TX 78612-3689 | americanmetabolix.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 08/31/2021 | Exile Super Shock | New York Nutrition Company / American Metabolix | 1083 FM 812 Unit B Cedar Creek, TX 78612-3689 | americanmetabolix.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 08/31/2021 | Havok Hardcore | New York Nutrition Company / American Metabolix | 1083 FM 812 Unit B Cedar Creek, TX 78612-3689 | americanmetabolix.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 08/31/2021 | Keto Pump in Watermelon and Grape Flavors | New York Nutrition Company / American Metabolix | 1083 FM 812 Unit B Cedar Creek, TX 78612-3689 | americanmetabolix.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 08/26/2021 | Fibrolief Support Formula | Fibromyalgia Treatment Group - FTG, LLC | 1236 Lone Creek Drive Eagle, ID 83616 | fibromyalgiatreatmentgroup.com/landers/1/; fibrolief.com; neuropathytreatmentgroup.com; nerverenew.com; facebook.com/fibrolief | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/26/2021 | Nerve Renew | Fibromyalgia Treatment Group - FTG, LLC | 1236 Lone Creek Drive Eagle, ID 83616 | fibromyalgiatreatmentgroup.com/landers/1/; fibrolief.com; neuropathytreatmentgroup.com; nerverenew.com; facebook.com/fibrolief | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/26/2021 | Neuro Boost Optimizer | Fibromyalgia Treatment Group - FTG, LLC | 1236 Lone Creek Drive Eagle, ID 83616 | fibromyalgiatreatmentgroup.com/landers/1/; fibrolief.com; neuropathytreatmentgroup.com; nerverenew.com; facebook.com/fibrolief | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/26/2021 | Immune Support | Fibromyalgia Treatment Group - FTG, LLC | 1236 Lone Creek Drive Eagle, ID 83616 | fibromyalgiatreatmentgroup.com/landers/1/; fibrolief.com; neuropathytreatmentgroup.com; nerverenew.com; facebook.com/fibrolief | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/24/2021 | ISM5 Invisi Smart Mask | Invisi Smart Technologies UK LTD | 112 Cumberland House80 Scrubs Lane London NW10 6RF United Kingdom | invisismart.com/; shop.invisismart.com/; twitter.com/InvisiSmart | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 | Warning Letter | Devices |
|
| 08/24/2021 | ISM5 Invisi Smart Mask (Black Edition) | Invisi Smart Technologies UK LTD | 112 Cumberland House80 Scrubs Lane London NW10 6RF United Kingdom | invisismart.com/; shop.invisismart.com/; twitter.com/InvisiSmart | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 | Warning Letter | Devices |
|
| 08/24/2021 | ISM30 Invisi Smart Mask | Invisi Smart Technologies UK LTD | 112 Cumberland House80 Scrubs Lane London NW10 6RF United Kingdom | invisismart.com/; shop.invisismart.com/; twitter.com/InvisiSmart | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 | Warning Letter | Devices |
|
| 08/19/2021 | “Patanjali Coronil Kit” (aka “Patanjali Divya Swasari Coronil Kit”) | Mahita, LLC dba PushMyCart | 415 Hillingdon Way Suwanee, GA 30024 | pushmycart.com; facebook.com/pushmycartglobal | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 08/19/2021 | “Dr. Reckeweg Arsenic Album Dilution 30 CH" | Mahita, LLC dba PushMyCart | 415 Hillingdon Way Suwanee, GA 30024 | pushmycart.com; facebook.com/pushmycartglobal | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 08/19/2021 | “SBL Arsenicum Album Dilution 30 CH" | Mahita, LLC dba PushMyCart | 415 Hillingdon Way Suwanee, GA 30024 | pushmycart.com; facebook.com/pushmycartglobal | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 08/19/2021 | “Kerala Ayurveda Balarishtam" | Mahita, LLC dba PushMyCart | 415 Hillingdon Way Suwanee, GA 30024 | pushmycart.com; facebook.com/pushmycartglobal | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 08/19/2021 | “Kottakkal Balarishtam” | Mahita, LLC dba PushMyCart | 415 Hillingdon Way Suwanee, GA 30024 | pushmycart.com; facebook.com/pushmycartglobal | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 08/18/2021 | Themra Epimedyumlu Bitkisel Karisimli Macun | Various Distributors | n/a | Examination of imported goods - shipment addressed to an Amazon fulfillment center | Undeclared sildenafil | Public Notification | Drugs |
|
| 08/10/2021 | Various salt scrub products | Secret of the Islands | 5326 Bush River Rd. Columbia, SC 29212 | secretoftheislands.com; facebook.com/SecretoftheIslands | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 08/06/2021 | Modified Perilla & Mentha | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | Empowered Cordyceps | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | Empowered Reishi | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | AllerEase | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | Empowered Eleuthro | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | Sui Bian Guo | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | Chinese Herbal Shampoo | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | Jade Dew Ointment | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | Stop Pain Tincture | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | Dr. Bob’s Medicated Oil | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | Cut & Sore Ointment | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | E-C-Z Ointment | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | Organic Cactus Seed (Prickly Pear) Oil Antioxidant Facial Serum | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | Skin Soothing Ointment | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | Dragon’s Blood Liniment | Blue Poppy Enterprises Inc | 4804 SE 69th Avenue Portland, OR 97206 | bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 08/06/2021 | "Genesis Ultra Gold" | Genesis Nutrition Ultra Slim dba Genesis Ultra Slim | 10108 NW 77th Street Doral, FL 33178 | fastweightlossgarcinia.com; ketoultraslimplus.com; facebook.com/genesisultraslim; twitter.com/genesis_slim; instagram.com/genesis_slim/ | Unapproved New Drugs/Misbranded | Warning Letter | Drugs |
|
| 08/03/2021 | Non-alcohol-based consumer antiseptic nasal product, "NanoBio® Protect Over-The-Counter Nasal Antiseptic" | Blue Willow Biologics | 2311 Green Road Ann Arbor, MI 48105 | nanobioprotect.com; bluewillow.com; cvs.com/shop/nanobio-protect-nasal-antiseptic-prodid-160333 | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
* |
| 08/02/2021 | 365 Skinny High Intensity Pills | Je Dois L’avoir Boutique | n/a | jedoisavoir2020.com | Undeclared sibutramine | Recall | Drugs |
|
| 08/02/2021 | 365 Skinny Emergency Boutique | Je Dois L’avoir Boutique | n/a | jedoisavoir2020.com | Undeclared sibutramine | Recall | Drugs |
|
| 07/29/2021 | Neutralization Antibody Test kit (Colloidal Gold, Fluorescent, Elisa) | Lepu Medical Technology -Beijing- Co., Ltd. | No. 37 Chaoqian Rd.Changping Qu Beijing Shi,China | n/a | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 07/29/2021 | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | Lepu Medical Technology -Beijing- Co., Ltd. | No. 37 Chaoqian Rd.Changping Qu Beijing Shi,China | n/a | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 07/29/2021 | Saliva Antigen Rapid Test | Lepu Medical Technology -Beijing- Co., Ltd. | No. 37 Chaoqian Rd.Changping Qu Beijing Shi,China | n/a | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 07/28/2021 | Melatonin | Dr. Thomas Polucki Upper Cervical Chiropractic, Inc. | 25050 Peachland Ave #105 Newhall, CA 91321 | getbetterxshop.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 07/28/2021 | Nitric Oxide Support | Dr. Thomas Polucki Upper Cervical Chiropractic, Inc. | 25050 Peachland Ave #105 Newhall, CA 91321 | getbetterxshop.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 07/26/2021 | Hydro Pinapple [sic] Burn | Max Health; eBay Seller - jongu 4308 | Houston, TX | ebay.com | Undeclared sibutramine and desisobutylbenzylsibutramine | Public Notification | Drugs |
Recall |
| 07/26/2021 | “COVx-RDA Nasal Antigen Test” | Vivera Pharmaceuticals, Inc. | 26021 Pala Drive - St A Mission Viejo, CA 92691 | viveracovid19.com/covx-rda/; viverapharmaceuticals.com/products/ | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 07/26/2021 | “COVxRDA Saliva Antigen Test” | Vivera Pharmaceuticals, Inc. | 26021 Pala Drive - St A Mission Viejo, CA 92691 | viveracovid19.com/covx-rda/; viverapharmaceuticals.com/products/ | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 07/26/2021 | VIVERA + OMECARE Home Specimen Collection Kit | Vivera Pharmaceuticals, Inc. | 26021 Pala Drive - St A Mission Viejo, CA 92691 | hometestbox.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 07/23/2021 | Organic Blueberry White & Green Tea | TeaTaze, LLC | 1203 N Fieldcrest St Wichita, KS 67212 | teataze.com; facebook.com/teatazetea | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/23/2021 | Clean Green Energy Detox Tea | TeaTaze, LLC | 1203 N Fieldcrest St Wichita, KS 67212 | teataze.com; facebook.com/teatazetea | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/23/2021 | Tokusen Hinshucha Fuji Midori Green Tea | TeaTaze, LLC | 1203 N Fieldcrest St Wichita, KS 67212 | teataze.com; facebook.com/teatazetea | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/23/2021 | Vibrant Green Tea | TeaTaze, LLC | 1203 N Fieldcrest St Wichita, KS 67212 | teataze.com; facebook.com/teatazetea | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/23/2021 | Caffeine-Free Herbal Energy Tea | TeaTaze, LLC | 1203 N Fieldcrest St Wichita, KS 67212 | teataze.com; facebook.com/teatazetea | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/23/2021 | Ignited Oolong Slimming Tea | TeaTaze, LLC | 1203 N Fieldcrest St Wichita, KS 67212 | teataze.com; facebook.com/teatazetea | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/23/2021 | Power Puer Aged Tea | TeaTaze, LLC | 1203 N Fieldcrest St Wichita, KS 67212 | teataze.com; facebook.com/teatazetea | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/23/2021 | Silver Tranquility White Tea | TeaTaze, LLC | 1203 N Fieldcrest St Wichita, KS 67212 | teataze.com; facebook.com/teatazetea | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/22/2021 | “Regular Strength Nasadol CBD Nasal Spray” | MB Solutions, LLC/BioSpectrum CBD | 5980 Executive Dr. Suite A Madison, WI 53719 | biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/ | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2021 | “Extra Strength Nasadol CBD Nasal Spray” | MB Solutions, LLC/BioSpectrum CBD | 5980 Executive Dr. Suite A Madison, WI 53719 | biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/ | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2021 | “Pain Relief Roll-On” | MB Solutions, LLC/BioSpectrum CBD | 5980 Executive Dr. Suite A Madison, WI 53719 | biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/ | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2021 | “CBD Oil Tincture” (500 mg and 1500 mg) | MB Solutions, LLC/BioSpectrum CBD | 5980 Executive Dr. Suite A Madison, WI 53719 | biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/ | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2021 | “Sour Gummy Worms” (250 mg and 500 mg) | MB Solutions, LLC/BioSpectrum CBD | 5980 Executive Dr. Suite A Madison, WI 53719 | biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/ | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2021 | “CBD Gummy Worms” (250 mg and 500 mg) | MB Solutions, LLC/BioSpectrum CBD | 5980 Executive Dr. Suite A Madison, WI 53719 | biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/ | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2021 | “CBD Peach Rings” (250 mg and 500 mg) | MB Solutions, LLC/BioSpectrum CBD | 5980 Executive Dr. Suite A Madison, WI 53719 | biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/ | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2021 | “Watermelon Slices” (250 mg, 500 mg, and 1000 mg) | MB Solutions, LLC/BioSpectrum CBD | 5980 Executive Dr. Suite A Madison, WI 53719 | biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/ | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2021 | “CBD Gummy Bears” (500 mg and 1000 mg) | MB Solutions, LLC/BioSpectrum CBD | 5980 Executive Dr. Suite A Madison, WI 53719 | biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/ | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2021 | “1,000mg Canine CBD Oil” | MB Solutions, LLC/BioSpectrum CBD | 5980 Executive Dr. Suite A Madison, WI 53719 | biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/ | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2021 | “CBD Dog Treats” | MB Solutions, LLC/BioSpectrum CBD | 5980 Executive Dr. Suite A Madison, WI 53719 | biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/ | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2021 | Miss Slim | HIS | Palisades Park, NJ | missslimusa.com | Undeclared sibutramine | Recall | Drugs |
|
| 07/20/2021 | Lion’s Mane | Brilliant Enterprises LLC | 621 Main Street, Unit 182Gaylord, MI 49735 | levelupmushrooms.com; instagram.com/levelupmushrooms; twitter.com/LvlUpMushrooms | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 07/20/2021 | BoomChaga | Brilliant Enterprises LLC | 621 Main Street, Unit 182Gaylord, MI 49735 | levelupmushrooms.com; instagram.com/levelupmushrooms; twitter.com/LvlUpMushrooms | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 07/20/2021 | CordaCex | Brilliant Enterprises LLC | 621 Main Street, Unit 182Gaylord, MI 49735 | levelupmushrooms.com; instagram.com/levelupmushrooms; twitter.com/LvlUpMushrooms | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 07/20/2021 | LVL:MAX | Brilliant Enterprises LLC | 621 Main Street, Unit 182Gaylord, MI 49735 | levelupmushrooms.com; instagram.com/levelupmushrooms; twitter.com/LvlUpMushrooms | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 07/20/2021 | “Germaphobe’s Delight Spray” | Jordan’s Crossing Herbal Connections | 568 County Road 2307 Barnsdall, OK 74002 | jordanscrossing.net; youtube.com/watch?v=dWCJdjcjbfM | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 07/19/2021 | Alpha Male Plus | Alpha Male Plus | n/a | alphamaleplus.us | Undeclared tadalafil | Recall | Drugs |
|
| 07/14/2021 | Diabetic Patch (aka Herbal Diabetic Patch) | Healthy Livin' Solutions | 9169 W State St #628 Garden City, Idaho 83714 | healthylivin.solutions | New Drug | Online Advisory Letter | Drugs |
|
| 07/09/2021 | X Rated Honey For Men | Various Distributors | n/a | adameve.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 07/09/2021 | “COVIGEN AG-1 Covid-19 Self Detection Kit” | Biopolygen Corp. | 2207 East Carson St Carson, CA 90810 | biopolygen.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 07/09/2021 | “COVIDEX AB-1 Covid-19 Self Detection Kit” | Biopolygen Corp. | 2207 East Carson St Carson, CA 90810 | biopolygen.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 07/09/2021 | “COVID-19 Antigen and Antibody Combo Set” | Biopolygen Corp. | 2207 East Carson St Carson, CA 90810 | biopolygen.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 07/09/2021 | “Saliva Test Kit” | USH Diagnostics, Inc./covidinstanttest.net | 3456 E. 155th St. Kansas City, MO 64147 | covidinstanttest.net; ushealthdiagnostics.com/; facebook.com/covid19instanttest; twitter.com/covidathometest; instagram.com/covid19instanttest | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 07/09/2021 | “Rapid 10 Minute Antigen Test” | USH Diagnostics, Inc./covidinstanttest.net | 3456 E. 155th St. Kansas City, MO 64147 | covidinstanttest.net; ushealthdiagnostics.com/; facebook.com/covid19instanttest; twitter.com/covidathometest; instagram.com/covid19instanttest | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 07/09/2021 | “Rapid Dual Antibody Test” | USH Diagnostics, Inc./covidinstanttest.net | 3456 E. 155th St. Kansas City, MO 64147 | covidinstanttest.net; ushealthdiagnostics.com/; facebook.com/covid19instanttest; twitter.com/covidathometest; instagram.com/covid19instanttest | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 07/08/2021 | Immune Booster | 3RD Day Nutraceuticals, LLC | 225 N Main St, Suite 404 Bristol, CT 06010 | 3rddaynutra.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/08/2021 | Allergy Support | 3RD Day Nutraceuticals, LLC | 225 N Main St, Suite 404 Bristol, CT 06010 | 3rddaynutra.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/08/2021 | Inflammatory Response Support | 3RD Day Nutraceuticals, LLC | 225 N Main St, Suite 404 Bristol, CT 06010 | 3rddaynutra.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/08/2021 | Revive & Recover | 3RD Day Nutraceuticals, LLC | 225 N Main St, Suite 404 Bristol, CT 06010 | 3rddaynutra.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/07/2021 | Halodine nasal and oral “sanitizer” product lines that include, Halodine Nasal Antiseptic Swabstick, Halodine Nasal Antiseptic, Halodine Oral Antiseptic Spray and Halodine Oral Rinse | Halodine, LLC | 111 NE 1st St, Suite 806 Miami, FL 33132-2506 | halodine.com; shop.halodine.com; twitter.com/TheHalodine; facebook.com/halodine | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 07/01/2021 | Genesis Ultra Slim Gold | Genesis Nutrition Ultra Slim dba Genesis Ultra Slim | 10108 NW 77th StreetDoral, FL 33178 | fastweightlossgarcinia.com | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
Warning Letter |
| 07/01/2021 | High Vitality Full Spectrum Liquid Multi-Vitamin | Phoenix Nutritionals, Inc. | 4727 Terrace Drive San Diego, CA 92116-2515 | phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | High Vitality Caps | Phoenix Nutritionals, Inc. | 4727 Terrace Drive San Diego, CA 92116-2515 | phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | Best Cholesterol Support | Phoenix Nutritionals, Inc. | 4727 Terrace Drive San Diego, CA 92116-2515 | phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | Blood Sugar Support | Phoenix Nutritionals, Inc. | 4727 Terrace Drive San Diego, CA 92116-2515 | phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | Maximum Stress Support | Phoenix Nutritionals, Inc. | 4727 Terrace Drive San Diego, CA 92116-2515 | phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | Complete Joint Support | Phoenix Nutritionals, Inc. | 4727 Terrace Drive San Diego, CA 92116-2515 | phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | Natural Anti-Inflammatory Support | Phoenix Nutritionals, Inc. | 4727 Terrace Drive San Diego, CA 92116-2515 | phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | Best Immune Support | Phoenix Nutritionals, Inc. | 4727 Terrace Drive San Diego, CA 92116-2515 | phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | Altitude RX | Biomedical Research Laboratories, LLC | 7590 Fay Ave Suite 202 La Jolla, CA 92037-4885 | brlsports.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | Flexify | Biomedical Research Laboratories, LLC | 7590 Fay Ave Suite 202 La Jolla, CA 92037-4885 | brlsports.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | Calm Legs | Biomedical Research Laboratories, LLC | 7590 Fay Ave Suite 202 La Jolla, CA 92037-4885 | nativeorigins.com; brlscience.com; facebook.com/mynativeorigins | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | Collagen Peptides | Biomedical Research Laboratories, LLC | 7590 Fay Ave Suite 202 La Jolla, CA 92037-4885 | nativeorigins.com; brlscience.com; facebook.com/mynativeorigins | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | Prohemia | Biomedical Research Laboratories, LLC | 7590 Fay Ave Suite 202 La Jolla, CA 92037-4885 | nativeorigins.com; brlscience.com; facebook.com/mynativeorigins | New Drug/Misbranded | Warning Letter | Foods |
|
| 07/01/2021 | Trimmunity | Biomedical Research Laboratories, LLC | 7590 Fay Ave Suite 202 La Jolla, CA 92037-4885 | nativeorigins.com; brlscience.com; facebook.com/mynativeorigins | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/30/2021 | 365 SKINNY High Intensity | Je Dois Lavoir LLC | n/a | jedoisavoir2020.com; facebook.com/jdl2020; instagram.com/j_d_l2020 | Undeclared sibutramine | Public Notification | Drugs | |
| 06/23/2021 | ProbioticXL | Great Healthworks, Inc. | 4150 SW 28th Way Fort Lauderdale, FL 33312-5201 | greathealthworks.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 06/23/2021 | OmegaXL | Great Healthworks, Inc. | 4150 SW 28th Way Fort Lauderdale, FL 33312-5201 | greathealthworks.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 06/22/2021 | Immune Builder | Pacific Center of Health/Pacific Center of Health & Acupuncture | 8555 Aero Dr. Suite 107 San Diego, CA 92123 | pacificcenterofhealth.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 06/22/2021 | High Risk Environment Pack- NO SYMPTOMS | Pacific Center of Health/Pacific Center of Health & Acupuncture | 8555 Aero Dr. Suite 107 San Diego, CA 92123 | pacificcenterofhealth.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 06/22/2021 | Anti-Viral Herbal Formula | Pacific Center of Health/Pacific Center of Health & Acupuncture | 8555 Aero Dr. Suite 107 San Diego, CA 92123 | pacificcenterofhealth.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 06/22/2021 | Anti-Viral Herbal Pack – ACUTE ILLINESS | Pacific Center of Health/Pacific Center of Health & Acupuncture | 8555 Aero Dr. Suite 107 San Diego, CA 92123 | pacificcenterofhealth.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 06/22/2021 | Kitchen Sink | Pacific Center of Health/Pacific Center of Health & Acupuncture | 8555 Aero Dr. Suite 107 San Diego, CA 92123 | pacificcenterofhealth.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 06/22/2021 | Lung Formula Dry Cough | Pacific Center of Health/Pacific Center of Health & Acupuncture | 8555 Aero Dr. Suite 107 San Diego, CA 92123 | pacificcenterofhealth.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 06/22/2021 | Lung Formula Wet Cough | Pacific Center of Health/Pacific Center of Health & Acupuncture | 8555 Aero Dr. Suite 107 San Diego, CA 92123 | pacificcenterofhealth.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 06/22/2021 | Colloidal Silver | Pacific Center of Health/Pacific Center of Health & Acupuncture | 8555 Aero Dr. Suite 107 San Diego, CA 92123 | pacificcenterofhealth.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 06/22/2021 | Post COVID-19 Recovery | Pacific Center of Health/Pacific Center of Health & Acupuncture | 8555 Aero Dr. Suite 107 San Diego, CA 92123 | pacificcenterofhealth.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 06/10/2021 | Super Tonic | Natural Hope Herbals, LLC | 670 Phillips Road Millersburg, PA 17061-9044 | naturalhopeherbals.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/10/2021 | Respiratory Aid | Natural Hope Herbals, LLC | 670 Phillips Road Millersburg, PA 17061-9044 | naturalhopeherbals.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/10/2021 | Wild Cherry Honey Syrup | Natural Hope Herbals, LLC | 670 Phillips Road Millersburg, PA 17061-9044 | naturalhopeherbals.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/10/2021 | Ivy Oaky | Natural Hope Herbals, LLC | 670 Phillips Road Millersburg, PA 17061-9044 | naturalhopeherbals.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/10/2021 | Jewelweed Spray Combo Pack | Natural Hope Herbals, LLC | 670 Phillips Road Millersburg, PA 17061-9044 | naturalhopeherbals.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/10/2021 | Jewelweed Spray | Natural Hope Herbals, LLC | 670 Phillips Road Millersburg, PA 17061-9044 | naturalhopeherbals.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/10/2021 | Prostate Health | Natural Hope Herbals, LLC | 670 Phillips Road Millersburg, PA 17061-9044 | naturalhopeherbals.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/10/2021 | Kidney/Bladder | Natural Hope Herbals, LLC | 670 Phillips Road Millersburg, PA 17061-9044 | naturalhopeherbals.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/10/2021 | Bone & Tissue Connect | Natural Hope Herbals, LLC | 670 Phillips Road Millersburg, PA 17061-9044 | naturalhopeherbals.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/10/2021 | SARS-CoV-2 Antigen Rapid Qualitative Test | Innova Medical Group, Inc. | 800 E. Colorado Blvd., Suite 288 Pasadena, CA 91101 | n/a | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 06/07/2021 | Travel Care Probiotic | Flora Inc | 805 E. Badger Rd. Lynden, WA 98264-9502 | florahealth.com/us; pinterest.com/florahealth/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/07/2021 | Sleep•Essence | Flora Inc | 805 E. Badger Rd. Lynden, WA 98264-9502 | florahealth.com/us; pinterest.com/florahealth/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/07/2021 | Cardio•Essence | Flora Inc | 805 E. Badger Rd. Lynden, WA 98264-9502 | florahealth.com/us; pinterest.com/florahealth/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/07/2021 | Grape Seed Extract Plus | Flora Inc | 805 E. Badger Rd. Lynden, WA 98264-9502 | florahealth.com/us; pinterest.com/florahealth/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/07/2021 | Elderberry+, Elderberry Crystals | Flora Inc | 805 E. Badger Rd. Lynden, WA 98264-9502 | florahealth.com/us; pinterest.com/florahealth/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/07/2021 | Flor•Essence | Flora Inc | 805 E. Badger Rd. Lynden, WA 98264-9502 | florahealth.com/us; pinterest.com/florahealth/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/07/2021 | Hydro-Therm Pumpkin Oil | Flora Inc | 805 E. Badger Rd. Lynden, WA 98264-9502 | florahealth.com/us; pinterest.com/florahealth/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/07/2021 | Pumpkin Oil | Flora Inc | 805 E. Badger Rd. Lynden, WA 98264-9502 | florahealth.com/us; pinterest.com/florahealth/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/07/2021 | Mãnuka Honey | Flora Inc | 805 E. Badger Rd. Lynden, WA 98264-9502 | florahealth.com/us; pinterest.com/florahealth/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 06/04/2021 | Miss Slim | Various Distributors | n/a | amazon.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 06/04/2021 | Adam’s Secret Extra Strength 2000 | Various Distributors | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 05/27/2021 | Berberine | Fresh Nutrition Inc | 23860 Nicole Way Yorba Linda, CA 92887-5626 | fresh-nutrition.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/27/2021 | Echinacea | Fresh Nutrition Inc | 23860 Nicole Way Yorba Linda, CA 92887-5626 | fresh-nutrition.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/27/2021 | European Elderberry | Fresh Nutrition Inc | 23860 Nicole Way Yorba Linda, CA 92887-5626 | fresh-nutrition.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/27/2021 | Milk Thistle | Fresh Nutrition Inc | 23860 Nicole Way Yorba Linda, CA 92887-5626 | fresh-nutrition.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/27/2021 | Lion’s Mane Mushroom | Fresh Nutrition Inc | 23860 Nicole Way Yorba Linda, CA 92887-5626 | fresh-nutrition.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/27/2021 | Turmeric Curcumin | Fresh Nutrition Inc | 23860 Nicole Way Yorba Linda, CA 92887-5626 | fresh-nutrition.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/27/2021 | Fish Oil | Fresh Nutrition Inc | 23860 Nicole Way Yorba Linda, CA 92887-5626 | fresh-nutrition.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/27/2021 | Green Lipped Mussels | Fresh Nutrition Inc | 23860 Nicole Way Yorba Linda, CA 92887-5626 | fresh-nutrition.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/27/2021 | Various chlorine dioxide products, including “OCLO 3000E” | OCLO LLC/OCLO Nanotechnology Science | 220 SW 9th Ave, #506 Hallandale, FL 33009 | dioxidodecloro.us; facebook.com/Hallandale.Beach.2018/; oclo.ecrater.com/index.php | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 05/26/2021 | Super Naturals brand IBSolution | JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health | 1309 ½ S. Roxbury Dr. Los Angeles, CA 90035 | supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsrelief | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/26/2021 | Premium Probiotic | JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health | 1309 ½ S. Roxbury Dr. Los Angeles, CA 90035 | supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsrelief | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/26/2021 | Sleep Solution | JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health | 1309 ½ S. Roxbury Dr. Los Angeles, CA 90035 | supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsrelief | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/26/2021 | Joint Solution | JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health | 1309 ½ S. Roxbury Dr. Los Angeles, CA 90035 | supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsrelief | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/26/2021 | Ultra Omega Fish Oil | JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health | 1309 ½ S. Roxbury Dr. Los Angeles, CA 90035 | supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsrelief | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/24/2021 | Brazilian Propolis Extract | Beauty & Spa Concepts, DBA Beenefits | 10765 Southwest 108th Ave. #308 Miami, FL 33176 | beenefits.com; instagram.com/beenefits/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 05/24/2021 | CoronaBox | Everything Health LLC | 1445 293rd Ave NE Carnation, WA 98014 | ssnaturalhealing.com; facebook.com/ssdallastx/; instagram.com/tamikamoseley/; twitter.com/sicklesolution | Unapproved and Misbranded Products Related to Coronavirus Disease 2019(COVID-19) | Warning Letter | Foods |
|
| 05/20/2021 | “NaturaCure” | NS Products, Inc. | 11721 State Ave Marysville, WA 98271 | naturacure.net | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/20/2021 | “OVOENERGEN™ CoenzymeQ10” | Fertility Nutraceuticals LLC | 21 E 69th St New York, NY 10021 | fertilitynutraceuticals.com; fertilitysupplementstore.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/20/2021 | “FERTINATAL® DHEA” | Fertility Nutraceuticals LLC | 21 E 69th St New York, NY 10021 | fertilitynutraceuticals.com; fertilitysupplementstore.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/20/2021 | “CONFLAM- Forte™” | Fertility Nutraceuticals LLC | 21 E 69th St New York, NY 10021 | fertilitynutraceuticals.com; fertilitysupplementstore.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/20/2021 | “CONCEPTION MEN Male Fertility” | EU Natural Inc. | 2654 W Horizon Ridge Pkwy Ste B5-93 Henderson, NV 89052 | store.eunatural.com; instagram.com/eunatural/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/20/2021 | “CONCEPTION Female Fertility Prenatal” | EU Natural Inc. | 2654 W Horizon Ridge Pkwy Ste B5-93 Henderson, NV 89052 | store.eunatural.com; instagram.com/eunatural/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/20/2021 | “ConceiveEasy” | LeRoche Benicoeur dba ConceiveEasy | 1130 Fremont Blvd #301 Seaside, CA 93955 | conceiveeasy.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/20/2021 | “FertilHerb for Womenr” | Sal Nature LLC/FertilHerb | 1621 Central Ave Cheyenne, WY 82001-4531 | fertilherb.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/19/2021 | “BIOCENCE WS Multi-use Selective Antibacterial / Antiviral Human OTC Drug” | BGP, LLC | 2118 Wilshire Blvd Santa Monica, CA 90403 | biocence.com; facebook.com/Biocence; instagram.com/biocence | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 05/12/2021 | Lipodrene w/25mg Ephedra Extract Dietary Supplement | Hi-Tech Pharmaceuticals. Inc | Norcross, GA | n/a | Presence of 1,4-dimethylamylamine (DMAA) | Recall | Foods |
|
| 05/10/2021 | Collagen Endurance Plus | Great Lakes Gelatin Company | 253 Commerce Dr., Ste 101 Grayslake, IL 60030 | greatlakesgelatin.com facebook.com/greatlakesgel/; pinterest.com/greatlakesgel/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/10/2021 | Keto Collagen + MCT | Great Lakes Gelatin Company | 253 Commerce Dr., Ste 101 Grayslake, IL 60030 | greatlakesgelatin.com facebook.com/greatlakesgel/; pinterest.com/greatlakesgel/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/10/2021 | Collagen Hydrolysate (10 oz unflavored and vanilla, mixed berry, lemon + lime, apple + cucumber, chocolate, and chai flavors, 16 oz unflavored, Convenience Pack (20 count unflavored), 8lb unflavored) | Great Lakes Gelatin Company | 253 Commerce Dr., Ste 101 Grayslake, IL 60030 | greatlakesgelatin.com facebook.com/greatlakesgel/; pinterest.com/greatlakesgel/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 05/06/2021 | DISINFECT™ & SHIELD HAND SANITIZER non-alcohol based hand sanitizer products | Disinfect & Shield | 1616 Fountain View Drive Houston, TX 77057 | disinfectandshield.com | Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 05/06/2021 | Non-alcohol based hand sanitizer products | Covalon Technologies Inc. | 1660 Tech Avenue, Unit 5 Mississauga ON L4W 5S7 Canada | covaguard.com; instagram.com/covaguard/; facebook.com/covaguard/ | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 05/04/2021 | GenBody COVID-19 IgM/IgG test | Baltimore Beauty Security Square Mall | 6901 Security Square Blvd. #343 Baltimore, MD 21244 | n/a | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 05/04/2021 | GenBody COVID-19 Ag test | Baltimore Beauty Security Square Mall | 6901 Security Square Blvd. #343 Baltimore, MD 21244 | n/a | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 04/29/2021 | Tummy Tuck Max | Various Distributors | n/a | n/a | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 04/29/2021 | Enerup Premium | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 04/29/2021 | ErectMax | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 04/29/2021 | Vital Sex | Various Distributors | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
|
| 04/29/2021 | Iodine Detoxified | Crown Wellness, Inc. | 421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138 | crownwellness.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/29/2021 | Karma Cleanse | Crown Wellness, Inc. | 421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138 | crownwellness.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/29/2021 | E3 Digestive Enzymes Supreme | Crown Wellness, Inc. | 421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138 | crownwellness.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/29/2021 | Diatomaceous Earth Powder (DE) | Crown Wellness, Inc. | 421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138 | crownwellness.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/29/2021 | E3 Renew Me/B.G. Blue Green Algae | Crown Wellness, Inc. | 421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138 | crownwellness.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/29/2021 | Clinic’s Choice CLO2 | Crown Wellness, Inc. | 421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138 | crownwellness.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/28/2021 | Herpes Protocol Ultimate Kit | The Underground Cure | P.O. Box 1111 Snellville, GA 30078 | theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 04/28/2021 | Herpes Protocol Vitamin Kit | The Underground Cure | P.O. Box 1111 Snellville, GA 30078 | theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 04/28/2021 | Olive Leaf Extract | The Underground Cure | P.O. Box 1111 Snellville, GA 30078 | theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 04/28/2021 | DMSO Liquid 70/30 | The Underground Cure | P.O. Box 1111 Snellville, GA 30078 | theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 04/28/2021 | Gentiana Complex | The Underground Cure | P.O. Box 1111 Snellville, GA 30078 | theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 04/27/2021 | “HM-FORMULA” | NeuroHydrate LLC | 4637 Main St, Unit 5 Bridgeport, CT 06606-1838 | neurohydrate.com/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/21/2021 | Pixie Dust Magnesium | DRF LLC | United States | doctorfarrah.com; drfarrah.online | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/21/2021 | Mega-Dose Vitamin C | DRF LLC | United States | doctorfarrah.com; drfarrah.online | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/21/2021 | Boston C | DRF LLC | United States | doctorfarrah.com; drfarrah.online | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/21/2021 | “Red 65” | North American Hirudin Biotech Products Inc. | 2531 Broadway, Suite A Everett, WA 98201 | ushirudin.com/; naturalhirudin.com/; buyred65.com/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/21/2021 | “Hirudin” | North American Hirudin Biotech Products Inc. | 2531 Broadway, Suite A Everett, WA 98201 | ushirudin.com/; naturalhirudin.com/; buyred65.com/ | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/15/2021 | Balanced Kollagen | Molecular BioLife International, Inc. | 200 W 16th St Bldg B Sheldon, IA 51201-2008 | molecularbiolife.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/15/2021 | Shark 2 Collagen | Molecular BioLife International, Inc. | 200 W 16th St Bldg B Sheldon, IA 51201-2008 | molecularbiolife.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/13/2021 | “COVID-19 Formula” | Trinity Natural Health & Pain Management, Inc. | 1100 NE 125th Street, Suite #203A North Miami, FL 33161 | trinity-naturalhealth.com/; facebook.com/TrinityNaturalSupplements | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 04/13/2021 | Apple Cider Vinegar Capsules | Orphic Nutrition | 2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115 | orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/13/2021 | Ashwagandha Capsules | Orphic Nutrition | 2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115 | orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/13/2021 | Garcinia Cambogia Capsules | Orphic Nutrition | 2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115 | orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/13/2021 | Premium Collagen Peptides Capsules | Orphic Nutrition | 2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115 | orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/13/2021 | Elderberry Gummies | Orphic Nutrition | 2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115 | orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/13/2021 | Omega 3 Fish Oil Softgels | Orphic Nutrition | 2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115 | orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/13/2021 | Turmeric Curcumin with Bioperin Capsules | Orphic Nutrition | 2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115 | orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/13/2021 | “Covid-19 Test Kit” | Anytime COVID Test LLC | 6615 West Boynton Beach Blvd., #181 Boynton Beach, FL 33437 | anytimecovidtest.com; mycovidtester.com; gotcovidtests.com; covidtestyou.com buymycovidtest.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 04/08/2021 | Alterra Sili-Mer G5 | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Anemia | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Cancer (Piptopet) | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Cancer (Specific Remedy) | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Cataract-L | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Fracture | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Heart | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Heart Murmur | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Heartworm | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Hip Dysplasia | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Parvopet | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Seizurepet | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Thyroidpet | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | Virus Defense Kit, which includes your Immunopet, Silverpet, and Cordyceps | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/08/2021 | White Blood Cells | Groupe Cyrenne Inc. dba HomeoAnimal | 1205 Des Chataigniers Quebec QC G3G 3C4 Canada | homeoanimal.com; facebook.com/homeoanimal | Unapproved New Animal Drug Products | Warning Letter | Veterinary |
|
| 04/07/2021 | Silver Soul Immune Support | Allure Imports | 405 E Easterday Ave., Unit 2, Sault Sainte Marie, MI 49783 | facedoctor.ca; vitalityc60.com allureimports.com facebook.com/facedoctorca/; facebook.com/vitalityc60; instagram.com/facedoctor.ca/; twitter.com/FaceDoctorRx/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs, Veterinary |
|
| 04/07/2021 | Silver Soul Body Spray | Allure Imports | 405 E Easterday Ave., Unit 2, Sault Sainte Marie, MI 49783 | facedoctor.ca; vitalityc60.com allureimports.com facebook.com/facedoctorca/; facebook.com/vitalityc60; instagram.com/facedoctor.ca/; twitter.com/FaceDoctorRx/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs, Veterinary |
|
| 04/07/2021 | Vitality C60 | Allure Imports | 405 E Easterday Ave., Unit 2, Sault Sainte Marie, MI 49783 | facedoctor.ca; vitalityc60.com allureimports.com facebook.com/facedoctorca/; facebook.com/vitalityc60; instagram.com/facedoctor.ca/; twitter.com/FaceDoctorRx/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs, Veterinary |
|
| 04/07/2021 | Puriton topical skin products | About Mineral | 3063 W. Chapman Ave., #6301 Orange, CA 92868 | aboutmineral.com; facebook.com/aboutmineral; instagram.com/about_mineral/; | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 04/07/2021 | Colox | Unived Inc | 16491 Scientific Way Irvine, CA 92618 | unived.us/; amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/07/2021 | CalDveg | Unived Inc | 16491 Scientific Way Irvine, CA 92618 | unived.us/; amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/07/2021 | B12+D3 | Unived Inc | 16491 Scientific Way Irvine, CA 92618 | unived.us/; amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/07/2021 | D3+K2-7 | Unived Inc | 16491 Scientific Way Irvine, CA 92618 | unived.us/; amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 04/06/2021 | “Rapid COVID-19 Antigen Self Test Kit” | Sethi Laboratories | 17290 Preston Road Suite 300 Dallas, TX 75252 | sethilaboratories.com; facebook.com/sethilabs; instagram.com/p/CGC8yKEHXZO; twitter.com/SethiLabsUS | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 04/06/2021 | “Rapid COVID-19 Antibody Self Test Kit” | Sethi Laboratories | 17290 Preston Road Suite 300 Dallas, TX 75252 | sethilaboratories.com; facebook.com/sethilabs; instagram.com/p/CGC8yKEHXZO; twitter.com/SethiLabsUS | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 04/01/2021 | Purity Essential Oil Blend products | Natural Adventure, LLC | 13765 SW 32nd Street Miramar, FL 33027 | mynaturaladventure.com; facebook.com/MyNatAdventure; instagram.com/mynatadventure/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 04/01/2021 | Purity Sanitizer with 70% Alcohol | Natural Adventure, LLC | 13765 SW 32nd Street Miramar, FL 33027 | mynaturaladventure.com; facebook.com/MyNatAdventure; instagram.com/mynatadventure/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 03/30/2021 | Immune Bio Green Cell | Immune & Genetics Protocols, LLC | 1655 SW 63rd ST RD Ocala, FL 34476 | biogreencell.com; facebook.com/BioGreenCell/ | New Drug/Misbranded | Warning Letter | Devices |
|
| 03/29/2021 | Formula I | Nature's Pharmacy, LLC | 1565 195th Avenue Bloomer, WI 54724 | naturespharmacyllc.com | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 03/29/2021 | Formula II | Nature's Pharmacy, LLC | 1565 195th Avenue Bloomer, WI 54724 | naturespharmacyllc.com | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 03/29/2021 | Formula III | Nature's Pharmacy, LLC | 1565 195th Avenue Bloomer, WI 54724 | naturespharmacyllc.com | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 03/29/2021 | Formula IV | Nature's Pharmacy, LLC | 1565 195th Avenue Bloomer, WI 54724 | naturespharmacyllc.com | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 03/29/2021 | Formula V | Nature's Pharmacy, LLC | 1565 195th Avenue Bloomer, WI 54724 | naturespharmacyllc.com | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 03/29/2021 | Magnesium Transdermal Patches | Better Supplement Solutions Inc. dba XanFree | 105 Overton St Deer Park, NY 11729 | xanfree.com; facebook.com/getxanfree | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 03/29/2021 | Tranquil Blend | Better Supplement Solutions Inc. dba XanFree | 105 Overton St Deer Park, NY 11729 | xanfree.com; facebook.com/getxanfree | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 03/29/2021 | Tranquil Blend + Magnesium Transdermal Combo | Better Supplement Solutions Inc. dba XanFree | 105 Overton St Deer Park, NY 11729 | xanfree.com; facebook.com/getxanfree | New Drug | Online Advisory Letter | Foods; Drugs |
|
| 03/29/2021 | Yin-Yang Essence Men Power | Various Distributors | n/a | ebay.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 03/29/2021 | Furious X 1350 | Various Distributors | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 03/29/2021 | Zing Plus | Various Distributors | n/a | amazon.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/25/2021 | “Akcutest COVID-19 Antibody Test” | Ikcon Investments, Inc dba Ikcon Medical | 14653 Caminito Lazanja San Diego, CA 92127 | ikconmedical.com; akcutestshop.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 03/25/2021 | “Lumigenik COVID-19 Antigen Rapid Test” | Ikcon Investments, Inc dba Ikcon Medical | 14653 Caminito Lazanja San Diego, CA 92127 | ikconmedical.com; akcutestshop.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 03/24/2021 | “COVID-19 IgM/IgG Rapid Test” | Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs | 424 S. Roadway New Orleans, LA 70124 | tmtestkits.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 03/19/2021 | Lipotriad Vision Support Plus | Lipotriad LLC | 5 Sentry Parkway East Suite 210 Blue Bell, PA 19422 | lipotriadvitamins.com; facebook.com/LipotriadVitamins; twitter.com/Lipotriad | New Drug/Misbranded | Warning Letter | Foods |
|
| 03/19/2021 | Lipotriad Dry Eye | Lipotriad LLC | 5 Sentry Parkway East Suite 210 Blue Bell, PA 19422 | lipotriadvitamins.com; facebook.com/LipotriadVitamins; twitter.com/Lipotriad | New Drug/Misbranded | Warning Letter | Foods |
|
| 03/19/2021 | Lipotriad Adult 50+ | Lipotriad LLC | 5 Sentry Parkway East Suite 210 Blue Bell, PA 19422 | lipotriadvitamins.com; facebook.com/LipotriadVitamins; twitter.com/Lipotriad | New Drug/Misbranded | Warning Letter | Foods |
|
| 03/19/2021 | Lipotriad Visionary | Lipotriad LLC | 5 Sentry Parkway East Suite 210 Blue Bell, PA 19422 | lipotriadvitamins.com; facebook.com/LipotriadVitamins; twitter.com/Lipotriad | New Drug/Misbranded | Warning Letter | Foods |
|
| 03/18/2021 | “Long Island Biotech COVID-19 Antigen Rapid Test (Colloidal Gold)” | Block Scientific | 22 Sawgrass Drive Bellport, NY 11713 | blockscientificstore.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 03/18/2021 | “QUIKPACII COVID-19 ANTIBODY TEST KIT” | Block Scientific | 22 Sawgrass Drive Bellport, NY 11713 | blockscientificstore.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 03/18/2021 | "Magnesium Oil Spray" | BioLyte Laboratories, LLC | 310 Northern Dr. NW, Grand Rapids, MI 49534 | N/A | CGMP/Finished Pharmaceuticals/Adulterated | Warning Letter | Drugs |
|
| 03/18/2021 | "Pain Relief Cream" | BioLyte Laboratories, LLC | 310 Northern Dr. NW Grand Rapids, MI 49534 | N/A | CGMP/Finished Pharmaceuticals/Adulterated | Warning Letter | Drugs |
|
| 03/18/2021 | "Therapeutic Pain Gel" | BioLyte Laboratories, LLC | 310 Northern Dr. NW, Grand Rapids, MI 49534 | N/A | CGMP/Finished Pharmaceuticals/Adulterated | Warning Letter | Drugs |
|
| 03/18/2021 | "Silver Liquid Supplement" | BioLyte Laboratories, LLC | 310 Northern Dr. NW, Grand Rapids, MI 49534 | N/A | CGMP/Finished Pharmaceuticals/Adulterated | Warning Letter | Drugs |
|
| 03/18/2021 | "Silver Gel with Aloe" | BioLyte Laboratories, LLC | 310 Northern Dr. NW, Grand Rapids, MI 49534 | N/A | CGMP/Finished Pharmaceuticals/Adulterated | Warning Letter | Drugs |
|
| 03/18/2021 | "Silver Gel" | BioLyte Laboratories, LLC | 310 Northern Dr. NW, Grand Rapids, MI 49534 | N/A | CGMP/Finished Pharmaceuticals/Adulterated | Warning Letter | Drugs |
|
| 03/16/2021 | Fucoidan | Anna Health, LLC | 9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550 | annahealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 03/16/2021 | Prostate Health | Anna Health, LLC | 9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550 | annahealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 03/16/2021 | Children Liquid Vitamins | Anna Health, LLC | 9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550 | annahealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 03/16/2021 | Immune Health | Anna Health, LLC | 9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550 | annahealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 03/16/2021 | Fucoidan | Duoc Thao Tre Xanh, LLC | 9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550 | duocthaotrexanh.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 03/16/2021 | Papaya Leaf Extract | Duoc Thao Tre Xanh, LLC | 9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550 | duocthaotrexanh.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 03/16/2021 | Ganoderma Lucidum Red Reishi Mushroom | Duoc Thao Tre Xanh, LLC | 9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550 | duocthaotrexanh.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 03/16/2021 | Immune Health | Duoc Thao Tre Xanh, LLC | 9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550 | duocthaotrexanh.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 03/15/2021 | “ELIXICURE PAIN RELIEF with CBD” products | Honest Globe, Inc. | 3605 West Macarthur Boulevard, Suite 701 Santa Ana, CA 92704-6845 | N/A | CGMP/Finished Pharmaceuticals/Adulterated | Warning Letter | Drugs |
|
| 03/12/2021 | “ROSE FREQUENCY TONGUE TINCTURE” | Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials | 351 NW Pleasant View Dr, Grants Pass OR 37526 | ravenscroftescentials.com; instagram.com/ravenscroftoils | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 03/12/2021 | "ELEVATION OF MIND AROMAMIST” | Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials | 351 NW Pleasant View Dr, Grants Pass OR 37526 | ravenscroftescentials.com; instagram.com/ravenscroftoils | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 03/12/2021 | “HEALER’s CHAI AROMATEA & BREATH DROPS” | Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials | 351 NW Pleasant View Dr, Grants Pass OR 37526 | ravenscroftescentials.com; instagram.com/ravenscroftoils | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 03/12/2021 | “AIR PURIFY AROMAMIST” | Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials | 351 NW Pleasant View Dr, Grants Pass OR 37526 | ravenscroftescentials.com; instagram.com/ravenscroftoils | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 03/05/2021 | 2 Own The Knight Silver 4000 | Various Distributors | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 03/05/2021 | Rhino SE7EN2 | Various Distributors | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 03/05/2021 | Stiff Rox | Various Distributors | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 03/05/2021 | Titanium 18K | Various Distributors | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 03/05/2021 | "IoWipe," Hand wipe product | CAMA Wellness Center/IodoRios Company, LLC | 6782 Germantown Ave. Philadelphia, PA 19119 | cp.camacenter.com; facebook.com/IoWipe | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 03/01/2021 | "Balance CBD Drops" | Cannafyl | 7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250 | cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/ | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 03/01/2021 | "Relief CBD Drops" | Cannafyl | 7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250 | cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/ | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 03/01/2021 | "Relax CBD Drops" | Cannafyl | 7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250 | cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/ | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 03/01/2021 | "Relief CBD Salve" | Cannafyl | 7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250 | cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/ | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 03/01/2021 | “Immunoral” | Ageless Global, LLC | 2722 S. West Temple, Salt Lake City, UT 84115 | agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 03/01/2021 | “Immune Plus” | Ageless Global, LLC | 2722 S. West Temple, Salt Lake City, UT 84115 | agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 03/01/2021 | “MD Immune Support Spray” | Ageless Global, LLC | 2722 S. West Temple, Salt Lake City, UT 84115 | agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 03/01/2021 | “MD CVK-365 Mouth Spray” | Ageless Global, LLC | 2722 S. West Temple, Salt Lake City, UT 84115 | agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 02/26/2021 | Vy & Tea | Qikmoov, LLC | n/a | vyteaus.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 02/26/2021 | “LUNGENE [sic] SARS-CoV-V-2 Covid-19 IgG/IgM Rapid Antibody Test Cassette to Detect Previous Corona Virus Infections” | Orvic dba Webstore-USA | 15922 Strathern St #16, Van Nuys, CA 91406 | facemaskandppestore.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 02/24/2021 | Alpha Male Plus (also referred to as Alpha Male+) | Various Distributors | n/a | alphamaleplus.us | Undelclared tadalafil | Public Notification | Drugs |
|
| 02/18/2021 | MindSoothe Drops | Native Remedies dba Silver Star Brands | 250 City Center, Oshkosh, WI 54906 | nativeremedies.com | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | MindSoothe Capsules | Native Remedies dba Silver Star Brands | 250 City Center, Oshkosh, WI 54906 | nativeremedies.com | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | Mood Support | Mountain Peak Nutritionals | 9953 SW Arctic Dr., Beaverton, OR 97005 | mountainpeaknutritionals.com | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | Natural Anxiety & Depression Relief | Wholesome Wellness | 6804 NE 79th Court, Portland, OR 97218 | wholesome-wellness.com | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | Mood Boosting Probiotic | Lifted Naturals | 1101 Mulberry St, A2 Suite 10, Kansas City, MO 64101 | liftednaturals.com | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | “Enlifta Mood Elevator” | Enlifta, LLC | 16372 Page St., Omaha, NE 68118 | enlifta.com; amazon.com/Doctor-Designed-Depression-Enlifta-Supplement/dp/B00STR2MLQ/ | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | “Enlifta Anxiety” | Enlifta, LLC | 16372 Page St., Omaha, NE 68118 | enlifta.com; amazon.com/Doctor-Designed-Depression-Enlifta-Supplement/dp/B00STR2MLQ/ | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | St. John’s Wort | Blossom Nature, LLC | 1193 Elederberry Circle, Folsom, CA 95630 | blossom-nature.com; amazon.com/Supplement-National-Antidepressant-Support-Provides-Relief-120/dp/B082TTLJGP | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | Full Spectrum™ St. John's Wort Extract | ProHealth Inc. | 555 Maple St, Carpinteria, CA 93013 | prohealth.com | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | Dr. Garber's Depression Relief | Dr. Garber’s Natural Solutions | 2607 2nd St #1, Santa Monica, CA 90405 | drgarbers.com | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | Inositol 100% Pure Free Form | FDC Nutrition Inc. | 2313 East Philadelphia Street Ste L, Ontario, CA | fdcnutrition.com | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | Sleep Sana “Sleep Drops” | SANA Group LLC | 1200 E. Woodhurst S-200, Springfield, MO 65804 | sleepsana.com | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | Sleep Sana “Sleep Shots” | SANA Group LLC | 1200 E. Woodhurst S-200, Springfield, MO 65804 | sleepsana.com | New Drug/Misbranded | Warning Letter | Foods |
News Release |
| 02/18/2021 | “Liposomal Vitamin C” | Mercola.com, LLC | 125 SW 3rd Place, Suite 205, Cape Coral, FL 33991 | mercola.com; mercolamarket.com; twitter.com/mercola | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 02/18/2021 | “Liposomal Vitamin D3” | Mercola.com, LLC | 125 SW 3rd Place, Suite 205, Cape Coral, FL 33991 | mercola.com; mercolamarket.com; twitter.com/mercola | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 02/18/2021 | “Quercetin and Pterostilbene Advanced” | Mercola.com, LLC | 125 SW 3rd Place, Suite 205, Cape Coral, FL 33991 | mercola.com; mercolamarket.com; twitter.com/mercola | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 02/18/2021 | Earth Tea Extra Strength | B4B Corp. | 40 Remsen Ave, Brooklyn, NY 11212 | b4bcorp.com; twitter.com/b4bcorpusa | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 02/18/2021 | The Prevention 12 Pak (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) | SafaLab, Inc. | 317 Cascade Ave., Langley, WA 98260 | safalab.com; weeksmd.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 02/16/2021 | “COVID-Aid Tincture” | Dr. Paul's Lab | 9559 County Road Y, Mazomanie, WI 53560 | drpaulslab.net; drsarahsessentials.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 02/11/2021 | “BioCBD+ Total Body Care” | Evolved Ayurvedic Discoveries, Inc./BioCBDPlus | 315 S. Coast Highway 101 Suite U75, Encinitas, CA 92024 | biocbdplus.com; facebook.com/BioCBDPlus; instagram.com/bio_cbd_plus | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 02/11/2021 | “BioCBD+ Topical Oil Muscle & Joint Support” | Evolved Ayurvedic Discoveries, Inc./BioCBDPlus | 315 S. Coast Highway 101 Suite U75, Encinitas, CA 92024 | biocbdplus.com; facebook.com/BioCBDPlus; instagram.com/bio_cbd_plus | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 02/11/2021 | “BioCBD+ Peace Vape” | Evolved Ayurvedic Discoveries, Inc./BioCBDPlus | 315 S. Coast Highway 101 Suite U75, Encinitas, CA 92024 | biocbdplus.com; facebook.com/BioCBDPlus; instagram.com/bio_cbd_plus | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 02/02/2021 | “OsteoBLAST®” | Clarke Pharmaceutical Manufacturing, Inc. | 17448 Highway 3 Ste. 141, Webster, TX 77598 | clarkepharmaceuticals.com | Unapproved New Drugs/Misbranded | Warning Letter | Drugs |
|
| 02/02/2021 | “Cell Block #19” | Clarke Pharmaceutical Manufacturing, Inc. | 17448 Highway 3 Ste. 141, Webster, TX 77598 | clarkepharmaceuticals.com | Unapproved New Drugs/Misbranded | Warning Letter | Drugs |
|
| 02/02/2021 | “High Potency Vitamin D3” | Clarke Pharmaceutical Manufacturing, Inc. | 17448 Highway 3 Ste. 141, Webster, TX 77598 | clarkepharmaceuticals.com | Unapproved New Drugs/Misbranded | Warning Letter | Drugs |
|
| 02/02/2021 | “Neupanex®” | Clarke Pharmaceutical Manufacturing, Inc. | 17448 Highway 3 Ste. 141, Webster, TX 77598 | clarkepharmaceuticals.com | Unapproved New Drugs/Misbranded | Warning Letter | Drugs |
|
| 02/02/2021 | “Natural Progesterone Skin Cream” | Clarke Pharmaceutical Manufacturing, Inc. | 17448 Highway 3 Ste. 141, Webster, TX 77598 | clarkepharmaceuticals.com | Unapproved New Drugs/Misbranded | Warning Letter | Drugs |
|
| 01/25/2021 | “COVID-19 BLOOD SPOT COLLECTION PACKET” | EnMed MicroAnalytics, Inc. | 645 Meeting St, Suite 2, Charleston, SC 29403-4279 | enmedmicroanalytics.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 01/25/2021 | “SARS-CoV-2 SALIVA RT-PCR TEST COLLECTION PACKET" | EnMed MicroAnalytics, Inc. | 645 Meeting St, Suite 2, Charleston, SC 29403-4279 | enmedmicroanalytics.com | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Devices |
|
| 01/22/2021 | AloeCure VeraFlex | American Global Health Group, LLC | 11808 Northup Way, Suite W105, Bellevue, WA 98005 | aloecure.com; facebook.com/aloecure | New Drug/Misbranded | Warning Letter | Foods |
|
| 01/22/2021 | AloeCure Advanced Formula Capsule | American Global Health Group, LLC | 11808 Northup Way, Suite W105, Bellevue, WA 98005 | aloecure.com; facebook.com/aloecure | New Drug/Misbranded | Warning Letter | Foods |
|
| 01/22/2021 | AloeCure Pure Aloe Vera Extract | American Global Health Group, LLC | 11808 Northup Way, Suite W105, Bellevue, WA 98005 | aloecure.com; facebook.com/aloecure | New Drug/Misbranded | Warning Letter | Foods |
|
| 01/22/2021 | AloeCure Probiotic + Enzyme | American Global Health Group, LLC | 11808 Northup Way, Suite W105, Bellevue, WA 98005 | aloecure.com; facebook.com/aloecure | New Drug/Misbranded | Warning Letter | Foods |
|
| 01/19/2021 | Adam’s Secret Extra Strength 1500 | Various Distributors | n/a | adamssecret.co; walmart.com | Undeclared tadalafil and sildenafil | Public Notification | Drugs |
Recall |
| 01/19/2021 | Adam’s Secret Extra Strength 3000 Platinum | Various Distributors | n/a | adamssecret.co | Undeclared tadalafil and sildenafil | Public Notification | Drugs |
Recall |
| 01/14/2021 | “Golden Milk Electuary-Mushroom Cocoa Blend” | Sage Moon Apothecary LLC | 40 Main Street, Seal Harbor, ME 04675 | sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaine | New Drug/Misbranded | Warning Letter | Foods |
Closeout Letter |
| 01/14/2021 | “Golden Milk Electuary” | Sage Moon Apothecary LLC | 40 Main Street, Seal Harbor, ME 04675 | sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaine | New Drug/Misbranded | Warning Letter | Foods |
Closeout Letter |
| 01/14/2021 | “Beyond Elderberry Syrup” | Sage Moon Apothecary LLC | 40 Main Street, Seal Harbor, ME 04675 | sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaine | New Drug/Misbranded | Warning Letter | Foods |
Closeout Letter |
| 01/12/2021 | Allicin capsules | Allimax Us | 500 W Superior St Unit 2205, Chicago, IL 60654 | allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 01/12/2021 | Allicin creams | Allimax Us | 500 W Superior St Unit 2205, Chicago, IL 60654 | allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 01/12/2021 | Allicin gels | Allimax Us | 500 W Superior St Unit 2205, Chicago, IL 60654 | allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 01/12/2021 | Allicin sprays | Allimax Us | 500 W Superior St Unit 2205, Chicago, IL 60654 | allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 01/12/2021 | Allicin liquid products | Allimax Us | 500 W Superior St Unit 2205, Chicago, IL 60654 | allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 01/12/2021 | “Corona Destroyer Tea” | AusarHerbs | 201 S. D Street, Madera, CA 93639 | ausarherbs.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 01/06/2021 | Lion's Mane -All Natural Supplement | Entia Biosciences, Inc | 13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140 | totalnutraceutical.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 01/06/2021 | Antrodia Mushroom Powder | Entia Biosciences, Inc | 13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140 | totalnutraceutical.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 01/06/2021 | Maitake Mushroom Powder | Entia Biosciences, Inc | 13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140 | totalnutraceutical.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 01/06/2021 | Reishi Mushroom Powder | Entia Biosciences, Inc | 13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140 | totalnutraceutical.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 01/06/2021 | Cordyceps Mushroom Powder | Entia Biosciences, Inc | 13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140 | totalnutraceutical.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 01/06/2021 | Cordyceps - All Natural Mushroom Dietary Supplement | Entia Biosciences, Inc | 13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140 | totalnutraceutical.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 01/04/2021 | 4-Thieves Florida Tea Concentrate | Coco's Holistic Specialties & Apothecary | n/a | cocosholisticspecialties.org/; facebook.com/KaliLengua; twitter.com/CocoEtsy | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 01/04/2021 | 4-Thieves Florida Tea Powder | Coco's Holistic Specialties & Apothecary | n/a | cocosholisticspecialties.org/; facebook.com/KaliLengua; twitter.com/CocoEtsy | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 12/28/2020 | Smarter Curcumin | Smarter Nutrition, Inc. | 17870 Newhope St. Suite 104-480, Fountain Valley, CA 92708 | smarternutrition.com; facebook.com/smarternutrition1 | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/28/2020 | Smarter Ubiquinol | Smarter Nutrition, Inc. | 17870 Newhope St. Suite 104-480, Fountain Valley, CA 92708 | smarternutrition.com; facebook.com/smarternutrition1 | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/28/2020 | Smarter Vitamin D3 | Smarter Nutrition, Inc. | 17870 Newhope St. Suite 104-480, Fountain Valley, CA 92708 | smarternutrition.com; facebook.com/smarternutrition1 | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/22/2020 | Synotrex | Speedwinds Nutrition, Inc. | 818 SW 3rd Avenue, Portland, OR 97204 | speedwindsnutrition.com; synotrex.com; amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/22/2020 | Sephren | Speedwinds Nutrition, Inc. | 818 SW 3rd Avenue, Portland, OR 97204 | speedwindsnutrition.com; synotrex.com; amazon.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/22/2020 | RHINODOL CBD” nasal spray products | New Leaf Pharmaceuticals, LLC | 77 South Main Street, Newton, CT 06470 | newleafpharma.com; facebook/CBDMedicalProducts/ | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 12/22/2020 | Various human and animal products, promoted to contain cannabidiol (CBD) | NextL3vel Services Group, LLC dba This Stuff Is Good For You | 3400 W. Desert Inn Rd. Suite 2, Las Vegas, NV 89102 | thisstuffisgoodforyou.com; facebook.com/tsigfy; instagram.com/tsigfy | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs; Animal & Veterinary |
|
| 12/22/2020 | “WBRx Metered-Dose Inhaler" | Wellness BioSciences Rx | 9789 Katy Freeway #1801, Houston, TX 77024 | wbrxglobal.com; twitter.com/wellnessbiosrx | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 12/22/2020 | "WBRx Balance Softgels CBD” | Wellness BioSciences Rx | 9789 Katy Freeway #1801, Houston, TX 77024 | wbrxglobal.com; twitter.com/wellnessbiosrx | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 12/22/2020 | “WBRx Pure Wellness CBD” (“WBRx Combo Pack”) | Wellness BioSciences Rx | 9789 Katy Freeway #1801, Houston, TX 77024 | wbrxglobal.com; twitter.com/wellnessbiosrx | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 12/22/2020 | “WBRx Energy Oil Drops CBD” | Wellness BioSciences Rx | 9789 Katy Freeway #1801, Houston, TX 77024 | wbrxglobal.com; twitter.com/wellnessbiosrx | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 12/22/2020 | “WBRx Relief Balm CBD” | Wellness BioSciences Rx | 9789 Katy Freeway #1801, Houston, TX 77024 | wbrxglobal.com; twitter.com/wellnessbiosrx | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 12/22/2020 | “WBRx Sleep Oil Drops CBD | Wellness BioSciences Rx | 9789 Katy Freeway #1801, Houston, TX 77024 | wbrxglobal.com; twitter.com/wellnessbiosrx | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Warning Letter | Drugs |
|
| 12/22/2020 | “Canna Bees Rescue Blend” | Bee Delightful | n/a | beedelightful.com; facebook.com/BeeDelightfulUSA | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 12/21/2020 | “C BETTER DAILY Adult Regular Formula” | G & L Wellness, LLC | 2231 14th St S 114, Wisconsin Rapids, WI 54494 | glwellness.net | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Warning Letter | Drugs; Animal & Veterinary |
|
| 12/21/2020 | “C BETTER DAILY Adult Maximum Formula” | G & L Wellness, LLC | 2231 14th St S 114, Wisconsin Rapids, WI 54494 | glwellness.net | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Warning Letter | Drugs; Animal & Veterinary |
|
| 12/21/2020 | “C BETTER DAILY Soothing Formula” | G & L Wellness, LLC | 2231 14th St S 114, Wisconsin Rapids, WI 54494 | glwellness.net | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Warning Letter | Drugs; Animal & Veterinary |
|
| 12/21/2020 | “Flu Immune Drops” | Riverstone LLC | 51668 Blue River Dr, Blue River, OR 97413 | doctorschoice.org | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 12/21/2020 | “L-Lysine” | Riverstone LLC | 51668 Blue River Dr, Blue River, OR 97413 | doctorschoice.org | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 12/21/2020 | “Lysine Extra” | Riverstone LLC | 51668 Blue River Dr, Blue River, OR 97413 | doctorschoice.org | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 12/21/2020 | “Monolaurin” | Riverstone LLC | 51668 Blue River Dr, Blue River, OR 97413 | doctorschoice.org | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 12/21/2020 | Organic Liposomal Vitamin C | Sparrow Health & Performance LLC | 2000 Southlake Park Suite 150, Hoover, AL 35244 | sparrowclinic.com; facebook.com/sparrowclinic; instagram.com/sparrowclinic/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 12/21/2020 | Nanoemulsified D3K2 (also referred to as “Liquid Liposomal Vitamin D3 with K2” or “Liposomal Vitamin D3” | Sparrow Health & Performance LLC | 2000 Southlake Park Suite 150, Hoover, AL 35244 | sparrowclinic.com; facebook.com/sparrowclinic; instagram.com/sparrowclinic/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 12/21/2020 | Immune Support Package (which includes your Organic Liposomal Vitamin C, Nanoemulsified D3K2, and Virus Be Gone products, with Smart Silver as an optional add-on) | Sparrow Health & Performance LLC | 2000 Southlake Park Suite 150, Hoover, AL 35244 | sparrowclinic.com; facebook.com/sparrowclinic; instagram.com/sparrowclinic/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 12/18/2020 | “Glycostasis” | Reddy Naturals | 1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152 | reddynaturals.com; facebook.com/ReddyNaturals | New Drug/Misbranded | Warning Letter | Drugs |
|
| 12/18/2020 | “Glucosamine Curcumin” | Reddy Naturals | 1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152 | reddynaturals.com; facebook.com/ReddyNaturals | New Drug/Misbranded | Warning Letter | Drugs |
|
| 12/18/2020 | “Turmeric 50” | Reddy Naturals | 1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152 | reddynaturals.com; facebook.com/ReddyNaturals | New Drug/Misbranded | Warning Letter | Drugs |
|
| 12/18/2020 | “Turmeric Curcumin” | Reddy Naturals | 1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152 | reddynaturals.com; facebook.com/ReddyNaturals | New Drug/Misbranded | Warning Letter | Drugs |
|
| 12/18/2020 | “Cetyl Curcumin” | Reddy Naturals | 1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152 | reddynaturals.com; facebook.com/ReddyNaturals | New Drug/Misbranded | Warning Letter | Drugs |
|
| 12/18/2020 | “Ashwagandha” | Reddy Naturals | 1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152 | reddynaturals.com; facebook.com/ReddyNaturals | New Drug/Misbranded | Warning Letter | Drugs |
|
| 12/18/2020 | “Huruli” | Reddy Naturals | 1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152 | reddynaturals.com; facebook.com/ReddyNaturals | New Drug/Misbranded | Warning Letter | Drugs |
|
| 12/18/2020 | “Black Seed Oil” | Reddy Naturals | 1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152 | reddynaturals.com; facebook.com/ReddyNaturals | New Drug/Misbranded | Warning Letter | Drugs |
|
| 12/18/2020 | “Curcumin Turmerone” | Reddy Naturals | 1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152 | reddynaturals.com; facebook.com/ReddyNaturals | New Drug/Misbranded | Warning Letter | Drugs |
|
| 12/18/2020 | “Ashwagandha Honey” | Reddy Naturals | 1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152 | reddynaturals.com; facebook.com/ReddyNaturals | New Drug/Misbranded | Warning Letter | Drugs |
|
| 12/18/2020 | CloSYS Non-Irritating RINSE Mildly Flavored for SENSITIVE Mouths | Rowpar Pharmaceuticals | 16100 N. Greenway Hayden Loop #400, Scottsdale, AZ 85260 | closys.com; facebook.com/ClosSYS; twitter.com/closys | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 12/18/2020 | CloSYS Oral Spray | Rowpar Pharmaceuticals | 16100 N. Greenway Hayden Loop #400, Scottsdale, AZ 85260 | closys.com; facebook.com/ClosSYS; twitter.com/closys | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 12/18/2020 | CloSYS Non-Irritating RINSE UN-flavored for ULTRA SENSITIVE Mouths | Rowpar Pharmaceuticals | 16100 N. Greenway Hayden Loop #400, Scottsdale, AZ 85260 | closys.com; facebook.com/ClosSYS; twitter.com/closys | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 12/17/2020 | Triple SupremeZen Plus 3500 | Various Distributors; Recall by Yolo Studio/Hyobin LLC | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Shogun-X Black | Various Distributors; Recall by Ummzy LLC/Knabe Inc | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Triple SupremeZen Extreme 3500 | Various Distributors; including seller Otwo | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Thumbs Up 7 White 11K | Various Distributors; Recall by Nuri Trading LLC | n/a | amazon.com | Undeclared sildenafil, tadalafil and vardenafil | Public Notification | Drugs | |
| 12/17/2020 | Thumbs Up 7 Red 70K | Various Distributors; Recalls by Antoto-K and Ummzy LLC/Knabe Inc | n/a | amazon.com | Undeclared sildenafil, tadalafil and vardenafil | Public Notification | Drugs | |
| 12/17/2020 | Thumbs Up 7 Blue 69K | Various Distributors; Recall by Bit & Bet LLC | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Thumbs Up 7 Black 25K | Various Distributors; Recall by Nuri Trading LLC | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Rock Steady 72 Hours | Various Distributors; including seller Rock Steady 72 Hours | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Red Spartan 3000 | Various Distributors; including seller Amazon.com | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Premium OrgaZen 7000 | Various Distributors; Recall by NS NY Distributor Inc | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Premier Platinum 5000 (PremierZEN Platinum 5000) | Various Distributors; Recall by NANA Collection LLC/E-Factory NY | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | PremierZen Extreme 3000 | Various Distributors; Recalls by QMART and Yolo Studio | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | PremierZen Black 5000 | Various Distributors; Recall by Namoo Enterprise LLC/All-R0under | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Original White Dragon | Various Distributors; including seller A&D Health | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Krazy Night | Various Distributors; Recall by Ummzy LLC/Knabe Inc | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Kopi Jantan Tradisional Natural Herbs Coffee | Various Distributors; including seller smile_elephant | n/a | amazon.com | Undeclared sildenafil | Public Notification | Drugs | |
| 12/17/2020 | Imperial Platinum 2000 | Various Distributors; Recall by QMART | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Imperial Gold 2000 | Various Distributors; Recall by QMART | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Imperial Extreme 2000 | Various Distributors; Recall by S&B Shopper LLC | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Hot Rod | Various Distributors; including BZ USA LLC/BZ USA LLC | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Ginseng Power 5000 | Various Distributors; Recall by NS NY Distributor Inc | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Burro en Primavera 60000 | Various Distributors; Recall by QMART | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | 69MODE Blue 69 | Various Distributors; Recall by Nuri Trading LLC | n/a | amazon.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | 3 KO Gold XT | Various Distributors; including seller Vitality Mate | n/a | amazon.com | Undeclared vardenafil | Public Notification | Drugs | |
| 12/17/2020 | Shogun-X Platinum 7000 | Various Distributors; Recall by Nuri Trading LLC | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Triple SupremeZen Gold 3500 | Various Distributors; Recall by NANA Collection LLC/E-Factory NY | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Burn 7 | Various Distributors; including seller befitaholic | n/a | ebay.com | Undeclared phenolphthalein | Public Notification | Drugs | |
| 12/17/2020 | Premier maxxzen Platinum 12000 | Various Distributors; including seller Miracle8989 | n/a | ebay.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Poseidon Platinum 10000 | Various Distributors; including seller co.america | n/a | ebay.com | Undeclared vardenafil | Public Notification | Drugs | |
| 12/17/2020 | Poseidon Platinum 3500 | Various Distributors; including seller Yamtun7 | n/a | ebay.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Mero Macho | Various Distributors; including seller setec24 | n/a | ebay.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Gold Lion | Various Distributors; including seller unityhealth | n/a | ebay.com | Undeclared sildenafil | Public Notification | Drugs | |
| 12/17/2020 | White Panther | Various Distributors; including seller qualmart1-9 | n/a | ebay.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Triple Wicked Platinum | Various Distributors; including seller pricemasters_usa | n/a | ebay.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | The Super Panther 77k | Various Distributors; including seller qualmart1-9 | n/a | ebay.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Royal Honey | Various Distributors; including seller ahmedjamilmuslim | n/a | ebay.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | PremierZen Gold 7000 | Various Distributors; Recall by Miracle8989 | n/a | ebay.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | PremierZen Platinum 8000 | Various Distributors; Recall by Miracle8989 | n/a | ebay.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Blue Panther Extreme 75k | Various Distributors; including seller qualmart1-9 | n/a | ebay.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Black Stallion 9000 | Various Distributors; including seller qualmart1-9 | n/a | ebay.com | Undeclared tadalafil | Public Notification | Drugs | |
| 12/17/2020 | Lishou Slimming Coffee | Various Distributors; including seller annday14 | n/a | ebay.com | Undeclared sibutramine and desmethylsibutramine | Public Notification | Drugs | |
| 12/17/2020 | Li Da Daidaihua Plus | Various Distributors; including seller micki_jay | n/a | ebay.com | Undeclared phenolphthalein | Public Notification | Drugs | |
| 12/17/2020 | Imperla Elita Vitaccino | Various Distributors; Recall by Dash Xclusive | n/a | ebay.com | Undeclared sibutramine and fluoxetine | Public Notification | Drugs | |
| 12/17/2020 | Fruta Planta | Various Distributors; including seller aialoj0 | n/a | ebay.com | Undeclared sibutramine | Public Notification | Drugs | |
| 12/17/2020 | Fruta Bio | Various Distributors; including seller frutabio | n/a | ebay.com | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs | |
| 12/17/2020 | Super Slim | Various Distributors; including seller emmcli0 | n/a | ebay.com | Undeclared sibutramine and desmethylsibutramine | Public Notification | Drugs | |
| 12/15/2020 | “Oleander 4X” | Phoenix Biotechnology, Inc.; Avila Herbals, LLC | 8626 Tesoro Dr., Suite 801, San Antonio, TX 78217 4025 Childress Rd., Christiansburg, VA 24073 | phoenixbiotechnology.com; myoleander.com; avilaherbals.com; twitter.com/PhoenixBioInc | Finished Pharmaceuticals/Unapproved new drug | Warning Letter | Drugs |
|
| 12/10/2020 | "Chest Tea” | Prairie Dawn Herbs | 4250 S. Calhan Hwy Yoder, CO 80864-9669 | prairiedawnherbs.com | Finished Pharmaceuticals/Unapproved new drug | Warning Letter | Foods |
|
| 12/10/2020 | “Ginger Oil” | Prairie Dawn Herbs | 4250 S. Calhan Hwy Yoder, CO 80864-9669 | prairiedawnherbs.com | Finished Pharmaceuticals/Unapproved new drug | Warning Letter | Foods |
|
| 12/10/2020 | “Dandelion root Tincture” | Prairie Dawn Herbs | 4250 S. Calhan Hwy Yoder, CO 80864-9669 | prairiedawnherbs.com | Finished Pharmaceuticals/Unapproved new drug | Warning Letter | Foods |
|
| 12/10/2020 | “Echinacea purpurea Tincture” | Prairie Dawn Herbs | 4250 S. Calhan Hwy Yoder, CO 80864-9669 | prairiedawnherbs.com | Finished Pharmaceuticals/Unapproved new drug | Warning Letter | Foods |
|
| 12/10/2020 | “Antispasmodic Tincture” | Prairie Dawn Herbs | 4250 S. Calhan Hwy Yoder, CO 80864-9669 | prairiedawnherbs.com | Finished Pharmaceuticals/Unapproved new drug | Warning Letter | Foods |
|
| 12/10/2020 | “Ginger Tincture” | Prairie Dawn Herbs | 4250 S. Calhan Hwy Yoder, CO 80864-9669 | prairiedawnherbs.com | Finished Pharmaceuticals/Unapproved new drug | Warning Letter | Foods |
|
| 12/10/2020 | “Cayenne Tincture” | Prairie Dawn Herbs | 4250 S. Calhan Hwy Yoder, CO 80864-9669 | prairiedawnherbs.com | Finished Pharmaceuticals/Unapproved new drug | Warning Letter | Foods |
|
| 12/10/2020 | Vitamins | iThrive.health | n/a | ithrive.health; facebook.com/iTHRIVE.health/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 12/10/2020 | Quercetin products | iThrive.health | n/a | ithrive.health; facebook.com/iTHRIVE.health/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 12/10/2020 | Zinc products | iThrive.health | n/a | ithrive.health; facebook.com/iTHRIVE.health/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 12/10/2020 | Omega-3 products | iThrive.health | n/a | ithrive.health; facebook.com/iTHRIVE.health/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 12/10/2020 | Mineral products | Indigenous Products | Dallas, TX 75232 | facebook.com/Indigenous-Products-106070747498475/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 12/09/2020 | Healthy-Thin Energize” | Bodyhealth.com, LLC | 707 Cleveland St. Clearwater, FL 33755-4107 | bodyhealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/09/2020 | “Body Detox (Oral Spray)” | Bodyhealth.com, LLC | 707 Cleveland St. Clearwater, FL 33755-4107 | bodyhealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/09/2020 | “Omega 3 Health” | Bodyhealth.com, LLC | 707 Cleveland St. Clearwater, FL 33755-4107 | bodyhealth.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/07/2020 | “Thymosin Alpha 1” | Paradigm RE LLC | 1511 N. Convent 700-156 Bourbonnais, IL 60914 | paradigmpeptides.com/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 12/04/2020 | Fortify | Desert Alchemist LLC | Tucson, AZ | etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/04/2020 | Lion's Mane | Desert Alchemist LLC | Tucson, AZ | etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/04/2020 | The Great Work | Desert Alchemist LLC | Tucson, AZ | etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/04/2020 | Mind Ease | Desert Alchemist LLC | Tucson, AZ | etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/04/2020 | Sweet Balance | Desert Alchemist LLC | Tucson, AZ | etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/04/2020 | Happy Heart | Desert Alchemist LLC | Tucson, AZ | etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/04/2020 | Flair Snare | Desert Alchemist LLC | Tucson, AZ | etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/04/2020 | Cordycepts sinensis double extract | Desert Alchemist LLC | Tucson, AZ | etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/02/2020 | “Evening Primrose Oil” | Smoky Mountain Naturals, LLC | 3605 Nebraska Avenue Nashville, TN 37209 | smnutrition.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/02/2020 | “Beta Glucan" | Smoky Mountain Naturals, LLC | 3605 Nebraska Avenue Nashville, TN 37209 | smnutrition.com | New Drug/Misbranded | Warning Letter | Foods |
|
| 12/02/2020 | C60 (Carbon 60), including “AVOCADO C60 ANTI-VIRAL COMBO – VIRUS PREVENTION” | Heavenly Natural Products | 100 Monroe St #406 Centerton, AR 72719 | heavenlynaturalproducts.com; facebook.com/heavenlyc60; twitter.com/hnpC60; pinterest.com/heavenlynaturalproductsc/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 12/02/2020 | Colloidal silver, including "Heavenly Silver" | Heavenly Natural Products | 100 Monroe St #406 Centerton, AR 72719 | heavenlynaturalproducts.com; facebook.com/heavenlyc60; twitter.com/hnpC60; pinterest.com/heavenlynaturalproductsc/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 12/02/2020 | “VIRUS BIOSHIELD” | Rat's Army | 4126 US HWY 93 S Kalispell, MT 59901 | rats.army/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 12/02/2020 | "Dr. Hotze’s Immune Pak with Vitamins A, B, C, D, Zinc and Probiotics” | Health & Wellness Center International One, L.L.C. dba Hotze Vitamins | 20214 Braidwood, Ste. 215 Katy, TX 77450 | hotzehwc.com; hotzevitamins.com; facebook.com/Hotze-HWC/; facebook.com/MyHotzeVitamins/ twitter.com/hotzehealth.com; twitter.com/HotzeVitamins/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 12/02/2020 | “Dr. Hotze’s Kids Immune Pak” | Health & Wellness Center International One, L.L.C. dba Hotze Vitamins | 20214 Braidwood, Ste. 215 Katy, TX 77450 | hotzehwc.com; hotzevitamins.com; facebook.com/Hotze-HWC/; facebook.com/MyHotzeVitamins/ twitter.com/hotzehealth.com; twitter.com/HotzeVitamins/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 12/02/2020 | “Dr. Hotze’s Teen Immune Pak” | Health & Wellness Center International One, L.L.C. dba Hotze Vitamins | 20214 Braidwood, Ste. 215 Katy, TX 77450 | hotzehwc.com; hotzevitamins.com; facebook.com/Hotze-HWC/; facebook.com/MyHotzeVitamins/ twitter.com/hotzehealth.com; twitter.com/HotzeVitamins/ | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
|
| 11/24/2020 | U.S.A. Viagra | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/24/2020 | Stree Overlord | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil and ciprofloxacin | Public Notification | Drugs |
|
| 11/24/2020 | Rhinozen 69 Platinum 75000 | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/24/2020 | Rhino 99 Extreme 90000 | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/24/2020 | Rhino 96 Platinum 77000 | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/24/2020 | Rhino 69 Platinum 25000 | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/24/2020 | Rhino 69 Power 500K | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/24/2020 | Rhino 8 Platinum 80000 | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/24/2020 | Body Shape Weight Loss System | Various Distributors | n/a | Examination of imported goods | Undeclared sibutramine | Public Notification | Drugs |
|
| 11/24/2020 | Bigger Longer More Time More Sperms (sic) | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/24/2020 | Herb Viagra Male Sexual Stimulant | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/24/2020 | Magnum XXL 50K | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/24/2020 | Magnum XXL 9800 | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/24/2020 | V8 Super Energy | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/18/2020 | Vigorous Man | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/18/2020 | Livtone | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and fluoxetine | Public Notification | Drugs |
|
| 09/01/2020 | Red-E | The Protein Shoppe, LLC | 101 E Exp. 83 Ste. A-1 Pharr, TX 78557 | The Protein Shoppe, LLC | Undeclared sildenafil | Recall | Drugs |
|
| 07/09/2020 | Tenadam Herb | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Spiced Tea | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Nigerian Moringa Leaf Powder | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Jamaican Turmeric | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Bitter Wood | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Devil Horsewhip | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Mango Leaf | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Red Water Grass | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Sarsaparilla | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Marsh Marigold | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Sea Moss/Irish Moss | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Dog Blood | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Guava Leaf | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Jack in the Bush | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | King of the Forest | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | ETHIOPIAN ABISH (FENNUGREEK SEED PWD.) | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Ethiopian Traditional Talba (Flaxseed Meal Cereal) | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Fever Grass | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Jamaican Milk Wiss | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Spanish Needle | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Fig Leaf | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Diabetics | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Flax Seed Oil & Honey Blend | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Bitter Kola (Arogbo) | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Jamaican Bissy Powder | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Ghanian Black Spice | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Piss A Bed | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | White Pond Lily | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Purple Sage | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Quassia Wood | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Trumpet Leaf | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | White Jointa | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | White Sage | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Guinea Hen Weed | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Sundial Cassava Meal | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Cocoa Balls | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | African Fever Bush | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Mojo Bush | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Blood Leaf | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Wood & Root Tonic | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Koromantee | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Ashanti | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | African Manback Tonic | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Pimento | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Mitmitta (Cayenne Pepper) | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Mahogany Bark | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Chaney Root | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Cerasee Bay Leaves, Mango Bark | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Asthma | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Blood Pressure | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Heart | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Worms and Parasites | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Flu-Allergies /HayFever | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Arthritis | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Axum Traditional Ethiopian Honey Beverage | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Black Sage | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Black Wiss | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Cinnamon | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Palo De Brazil | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Broom Weed | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Bread Nut | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Jamaican and Tropical Raw Honey | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Hemp Seed Oil | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Talibah’s Tooth Powder and Ethiopian Coffee | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 07/09/2020 | Blue Vervain | Sundial Herbal Products | 3609 Boston Road, Bronx, NY | sundialherbs.com/sundial | Misbranding & Unapproved New Drugs | Recall | Foods |
|
| 05/20/2020 | Sterile Cannabidiol (CBD) previously listed as Cannabidiol (CBD) Complex | Biota Biosciences, LLC | Seattle, WA | n/a | Unapproved new drug; injectable products marketed without FDA approval | Recall | Drugs |
|
| 05/20/2020 | Sterile Curcumin previously listed as Curcumin Complex 4 10 mL | Biota Biosciences, LLC | Seattle, WA | n/a | Unapproved new drug; injectable products marketed without FDA approval | Recall | Drugs |
|
| 05/20/2020 | Sterile Cannabidiol (CBD) + Curcumin previously listed as Cannabidiol (CBD) + Curcumin Complex | Biota Biosciences, LLC | Seattle, WA | n/a | Unapproved new drug; injectable products marketed without FDA approval | Recall | Drugs |
|
| 05/19/2020 | Dr. Rima RecommendsTM Nano Silver 10 PPM | Natural Solutions Foundation | 58 Plotts Rd, Newton NJ 07860 | drrimatruthreports.com; opensourcetruth.com; truthaboutcoronavirus.com; nsfmarketplace.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Foods |
Recall |
| 05/11/2020 | “CORE” | Fusion Health and Vitality LLC | 1360 Union Hill Road Suite 11B, Alpharetta, GA 30004 | pharmorigins.com; freecoreoffer.online; immune-shot.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
Recall |
| 05/11/2020 | “IMMUNE SHOT” | Fusion Health and Vitality LLC | 1360 Union Hill Road Suite 11B, Alpharetta, GA 30004 | pharmorigins.com; freecoreoffer.online; immune-shot.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
Recall |
| 05/06/2020 | NAD+ Sublingual Gel | Alive By Nature, Inc. | 2574 Whispering Pines Dr. Fleming Island, FL 32003 | alivebynature.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 05/06/2020 | NMN Sublingual Gel | Alive By Nature, Inc. | 2574 Whispering Pines Dr. Fleming Island, FL 32003 | alivebynature.com | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | Warning Letter | Drugs |
|
| 04/22/2020 | Black Mamba Premium 18000 | Bandera Ice House | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 03/16/2020 | Active Male | Natural Remedy Store | San Antonio, TX | Natural Remedy Store | Undeclared tadalafil | Recall | Drugs |
|
| 02/24/2020 | Bow & Arrow | Med Man Distribution | n/a | Distributed in the USA to Regal Labs and to their nationwide retailers | Undeclared sildenafil | Recall | Drugs |
|
| 02/05/2020 | XXX Platinum WOODIE | Various Distributors | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 02/05/2020 | Alpha-Male | Various Distributors | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 02/05/2020 | RMFLEX | Various Distributors | n/a | ebay.com | Undeclared diclofenac | Public Notification | Drugs |
|
| 02/05/2020 | OrgaZEN Gold 5800 | Various Distributors | n/a | amazon.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/18/2019 | U-Dream Lite | Various Distributors | n/a | amazon.com | Undeclared eszopiclone and zopiclone | Public Notification | Drugs |
|
| 12/18/2019 | U-Dream Full Night | Various Distributors | n/a | amazon.com | Undeclared eszopiclone and zopiclone | Public Notification | Drugs |
|
| 12/17/2019 | SUPER Platinum 30000 RHINO 7 | Motto International Corp. | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 12/17/2019 | SUPER Platinum 30000 PANTHER | Motto International Corp. | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 12/17/2019 | SUPER Platinum 30000 STALLION | Motto International Corp. | n/a | n/a | Undeclared sildenafil, tadalafil, and dapoxetine | Public Notification | Drugs |
|
| 12/17/2019 | SUPER Platinum 30000 BULL | Motto International Corp. | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 12/13/2019 | PremierZEN Gold 7000 | Various Distributors | n/a | voltcandyonline.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 12/09/2019 | Essential Oils, including Bergamot bergaptene free (Citrus bergamia), Listea Cubea, Cypress – Cupressus sempervirens, Cinnamon Leaf – Cinnamomum zeylanicum, Chamomile Roman – Anthemis nobilis, and Carrot Seed – Daucus carota | Kelley Pure Essentials Oils | 404 W. 5th St. New Richmond, WI 54017 | kelleypureessentialoils.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/09/2019 | Herbal Detox Pearls | Coochie Couture | P.O. Box 251 Selden, NY 11784 | coochiecouture.net/; instagram.com/coochiecouture_/; facebook.com/coochiecouturee | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/09/2019 | Blood Sugar Ultra | Blood Sugar Ultra | 1140 S. Highbrook Street Suite 400 Akron, OH 44301 | healthtech24.net/diabetes-report; bloodsugarultra.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/09/2019 | SNAP Capsule Formula | Simply Natural Advanced Pharma (SNAP) | n/a | adhdsnap.com; facebook.com/SNAPtoday/; instagram.com/snap4health/; twitter.com/SNAP4ADHD | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/09/2019 | SNAP Liquid Formula | Simply Natural Advanced Pharma (SNAP) | n/a | adhdsnap.com; facebook.com/SNAPtoday/; instagram.com/snap4health/; twitter.com/SNAP4ADHD | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/04/2019 | Detox Plus | Various Distributors | n/a | International Mail Shipments | Undeclared tadalafil, paynantheine, and mitragynine | Public Notification | Drugs |
|
| 11/14/2019 | Power Khan | Various Distributors | n/a | powerkhanusa.com | Undeclared desmethyl thiosildenafil, thioaildenafil, and aildenafil | Public Notification | Drugs |
|
| 11/13/2019 | Man Erect | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/13/2019 | SHENGDA | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 09/06/2019 | Sheaya Lender | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and fluoxetine | Public Notification | Drugs |
|
| 10/24/2019 | CholesLo | HFL Solutions LLC | 13077 Bluff Creek Dr., Playa Vista, CA 90094 | choleslo.com | Undeclared lovastatin | Public Notification | Drugs |
Warning Letter |
| 10/17/2019 | Skinny Pill | Lose Fat Gain Life M&B | 4102 Orange Ave Ste 118 & 119, Long Beach, CA 90807 | losefatgainlifemb.com | Undeclared 1,3-dimethylamylamine (DMAA) | Public Notification | Foods |
Warning Letter |
| 10/16/2019 | UP2 | Various Distributors | n/a | hmherbs.com | Undeclared sildenafil | Public Notification | Drugs |
Recall |
| 10/09/2019 | CHU | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 09/26/2019 | Kim Whitening Pearl and Snowlotus Cream | Kim Co, LTD | 888/32 Bang Pree Industrial Estate , Samut Prakan, Samut Prakan Thailand | n/a | Found to contain 0.047 g/kg of mercury | Alert | Drugs |
Import Alert 53-18 |
| 09/26/2019 | Golden Pearl Beauty Cream | Golden Pearl Cosmetics | 115/1 M , Quaid-e-Azam Industrial Estate , Kot Lakhpat, Lahore, Punjab Pakistan | n/a | Found to contain 12 g/kg of mercury | Alert | Drugs |
Import Alert 53-18 |
| 09/26/2019 | Chandni Whitening Cream | SJ Enterprises | 222 CCA FF , DHA Phase 4 Sector CCA , Lahore, Punjab Pakistan | n/a | Found to contain 8.79 g/kg of mercury | Alert | Drugs |
Import Alert 53-18 |
| 09/26/2019 | Goree Beauty Cream | Goree Cosmetics | n/a | n/a | Found to contain 17.2 g/kg of mercury | Alert | Drugs |
|
| 09/26/2019 | Sandal Whitening Beauty Cream | MMC Cosmetics Pakistan | Main Bazar Rd , Karbirwala, Khanewal Pakistan | n/a | Found to contain 13.1 g/kg of mercury | Alert | Drugs |
Import Alert 53-18 |
| 09/26/2019 | Monespa Express Peeling | Various Distributors | n/a | n/a | Found to contain 5.03 g/kg of mercury | Alert | Drugs |
|
| 09/26/2019 | Face Fresh Beauty Cream | Shaheen Costmetics PVT LTD | House #8, Block-A4 , P.G.E.C.M.S Punjab Society , Lahore, Punjab Pakistan | n/a | Found to contain 18.5 g/kg of mercury | Alert | Drugs |
Import Alert 53-18 |
| 09/19/2019 | Green Lumbar | GL Holdings | Newport Beach, California | getgreenlumber.com; greenlumber.com | Undeclared tadalafil | Public Notification | Drugs |
Recall |
| 09/16/2019 | Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement | Fitoterapia USA Inc. | n/a | fitoterapiausa.com | Undeclared tadalafil | Recall | Drugs |
|
| 09/09/2019 | Anaconda Strong Formula | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 09/09/2019 | La Pepa Negra | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 09/09/2019 | Lung Leader | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 09/06/2019 | Lanugar | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and N-desmethylsibutramine | Public Notification | Drugs |
|
| 09/06/2019 | JaDera PLUS | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine, N-desmethylsibutramine, and benproperine | Public Notification | Drugs |
|
| 09/06/2019 | Love in S | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and N-desmethylsibutramine | Public Notification | Drugs |
|
| 09/06/2019 | LOBO | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 09/06/2019 | Mero Macho | Various Distributors | n/a | fitoterapiausa.com; meromachodrink.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 07/25/2019 | Chrysanthemum/Hibiscus Blend Tea | Moyeam USA TEA, LLC | n/a | pureamitea.com; getmoyeam.com | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Eagle Tea | Moyeam USA TEA, LLC | n/a | pureamitea.com; getmoyeam.com | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Qing Yun Moyeam Tea | Moyeam USA TEA, LLC | n/a | pureamitea.com; getmoyeam.com | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | NAD+/H2S Energizer | Alive By Nature, Inc. | 2574 Whispering Pines Dr. Fleming Island, FL 32003 | alivebynature.com | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | NAD+ Defender | Alive By Nature, Inc. | 2574 Whispering Pines Dr. Fleming Island, FL 32003 | alivebynature.com | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Pure NAD+ Sublingual tablets | Alive By Nature, Inc. | 2574 Whispering Pines Dr. Fleming Island, FL 32003 | alivebynature.com | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Pure NAD+ Sublingual powder | Alive By Nature, Inc. | 2574 Whispering Pines Dr. Fleming Island, FL 32003 | alivebynature.com | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Liquid NAD+ Sublingual drops | Alive By Nature, Inc. | 2574 Whispering Pines Dr. Fleming Island, FL 32003 | alivebynature.com | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Pure NAD+ Nasal Spray, | Alive By Nature, Inc. | 2574 Whispering Pines Dr. Fleming Island, FL 32003 | alivebynature.com | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | NMNs Sublingual tablets (30 ct and 240 ct) | Alive By Nature, Inc. | 2574 Whispering Pines Dr. Fleming Island, FL 32003 | alivebynature.com | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Pure NMN Sublingual powder | Alive By Nature, Inc. | 2574 Whispering Pines Dr. Fleming Island, FL 32003 | alivebynature.com | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Pulverexx | Doctor Eden LLC | 10030 NW 6th Terr. Miami, FL 33172 | doctoreden.com; facebook.com/dredenhealth/; twitter.com/DrMEden; pinterest.com/drmarioeden | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | GF20 Plus Oral Spray | Leading Edge Health | 100 Fidelitone Way Elizabethton, TN 37643 | leadingedgehealth.com; genf20.com; gen20.com | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | GF20 Plus Capsules | Leading Edge Health | 100 Fidelitone Way Elizabethton, TN 37643 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Moses Kit (Moses Cream + Moses Oil) | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | IQ+ Joy, Sleep, Anxiety | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Essential Eye Oil for Glaucoma | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Certified Organic Frankincense | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | High Blood Pressure Support | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Moses Lip Balm-Rose | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Moses Lip Balm-Natural | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Fix It All | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Moses Oils | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Moses Cream | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Clear Nose | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/25/2019 | Hair Maximizer | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Food; Drugs |
|
| 07/25/2019 | Cancer Support (Big C Support) | Bible Healing Oils | 111 5th Avenue East Buckeye, AZ 85326 | biblehealingoils.net | Unapproved New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 07/22/2019 | Bido CBD for Pets | Curaleaf, Inc. | 301 Edgewater Place Suite 405, Wakefield, MA 01880 | curaleafhemp.com | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2019 | CBD Disposable Vape Pen | Curaleaf, Inc. | 301 Edgewater Place Suite 405, Wakefield, MA 01880 | curaleafhemp.com | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2019 | CBD Tincture | Curaleaf, Inc. | 301 Edgewater Place Suite 405, Wakefield, MA 01880 | curaleafhemp.com | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2019 | CBD Pain-Relief Patch | Curaleaf, Inc. | 301 Edgewater Place Suite 405, Wakefield, MA 01880 | curaleafhemp.com | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/22/2019 | CBD Lotion | Curaleaf, Inc. | 301 Edgewater Place Suite 405, Wakefield, MA 01880 | curaleafhemp.com | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | Warning Letter | Drugs |
|
| 07/16/2019 | Reduktis Max | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/16/2019 | Black Storm | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/16/2019 | Big Penis | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/16/2019 | Boss Lion 9000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/16/2019 | De Guo Heijin Gang | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/16/2019 | Herb Viagra | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/16/2019 | La Pepa Negra | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/16/2019 | Odimafo Powerful Tablet 200 mg | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/16/2019 | Plant Vigra | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/16/2019 | Shengjingpian | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/16/2019 | Vigour 800 mg | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/01/2019 | Lipro Dietary Capsule | Various Distributors | n/a | liprodietpill.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 06/26/2019 | Adelgasin Plus | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and N-desmethyl sibutramine | Public Notification | Drugs |
|
| 06/26/2019 | Super Slimming Herb | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 06/26/2019 | Lishou Fuling Jiaonang | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and N-desmethyl sibutramine | Public Notification | Drugs |
|
| 06/26/2019 | Detoxi Slim | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 06/26/2019 | Absolute Nine Slim | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and N-desmethyl sibutramine | Public Notification | Drugs |
|
| 06/26/2019 | Peru Maca | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/26/2019 | Germany Black Gorilla | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/25/2019 | 12 Gram Kratom Powder Samples | Cali Botanicals, LLC | 500 Sibley Street, Folsom, CA 95630 | calibotanicals.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 06/25/2019 | Borneo yellow Vein Kratom | Cali Botanicals, LLC | 500 Sibley Street, Folsom, CA 95630 | calibotanicals.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 06/25/2019 | Bali Kratom Powder | Cali Botanicals, LLC | 500 Sibley Street, Folsom, CA 95630 | calibotanicals.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 06/25/2019 | Cali's Best Premium Powder Mix | Cali Botanicals, LLC | 500 Sibley Street, Folsom, CA 95630 | calibotanicals.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 06/25/2019 | Cali's Premium Special Reserve Kratom Powder | Cali Botanicals, LLC | 500 Sibley Street, Folsom, CA 95630 | calibotanicals.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 06/25/2019 | Enhanced Maeng Da Capsules | Cali Botanicals, LLC | 500 Sibley Street, Folsom, CA 95630 | calibotanicals.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 06/25/2019 | Green Malay Kratom Caps | Cali Botanicals, LLC | 500 Sibley Street, Folsom, CA 95630 | calibotanicals.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 06/25/2019 | Kratom Capsule Samples | Cali Botanicals, LLC | 500 Sibley Street, Folsom, CA 95630 | calibotanicals.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 06/25/2019 | Full Spectrum 50x Kratom Tincture | Cali Botanicals, LLC | 500 Sibley Street, Folsom, CA 95630 | calibotanicals.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 06/25/2019 | Super Enhanced Bali Kratom | Cali Botanicals, LLC | 500 Sibley Street, Folsom, CA 95630 | calibotanicals.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 06/25/2019 | Super Enhanced Maeng Da Kratom | Cali Botanicals, LLC | 500 Sibley Street, Folsom, CA 95630 | calibotanicals.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 06/23/2020 | Anti-Viral Immune Enhancement Capsules | Golden Nutrition Inc. | Opa Locka, FL | goldennutrition.com | Unsubstantiated Health Claims on Label | Recall | Foods |
|
| 06/06/2019 | SpiroNIL | PRL, Inc. | 84 West Fourth Avenue, Lobelville, TN 37097-3267 | forestcenterherbs.com | CGMP/Dietary Supplement/Adulterated/Misbranded | Warning Letter | Foods |
|
| 06/06/2019 | General Formula | PRL, Inc. | 84 West Fourth Avenue, Lobelville, TN 37097-3267 | forestcenterherbs.com | CGMP/Dietary Supplement/Adulterated/Misbranded | Warning Letter | Foods |
|
| 06/06/2019 | Black Walnut | PRL, Inc. | 84 West Fourth Avenue, Lobelville, TN 37097-3267 | forestcenterherbs.com | CGMP/Dietary Supplement/Adulterated/Misbranded | Warning Letter | Foods |
|
| 06/06/2019 | Alfalfa Herbal Tonic | PRL, Inc. | 84 West Fourth Avenue, Lobelville, TN 37097-3267 | forestcenterherbs.com | CGMP/Dietary Supplement/Adulterated/Misbranded | Warning Letter | Foods |
|
| 06/06/2019 | Kidney Formula #1 | PRL, Inc. | 84 West Fourth Avenue, Lobelville, TN 37097-3267 | forestcenterherbs.com | CGMP/Dietary Supplement/Adulterated/Misbranded | Warning Letter | Foods |
|
| 06/06/2019 | Kidney Formula #2 | PRL, Inc. | 84 West Fourth Avenue, Lobelville, TN 37097-3267 | forestcenterherbs.com | CGMP/Dietary Supplement/Adulterated/Misbranded | Warning Letter | Foods |
|
| 06/06/2019 | MicroNIL | PRL, Inc. | 84 West Fourth Avenue, Lobelville, TN 37097-3267 | forestcenterherbs.com | CGMP/Dietary Supplement/Adulterated/Misbranded | Warning Letter | Foods |
|
| 05/22/2019 | Man Fuel Xtreme Edition | Various Distributors | n/a | gomanfuel.com | Undeclared sildenafil, dithiodesmethyl carbodenafil and desmethyl carbodenafil | Public Notification | Drugs |
|
| 05/22/2019 | Man Fuel Male Enhancement Shooter (Tropical Fruit Flavor) | Various Distributors | n/a | gomanfuel.com | Undeclared tadalafil and desmethyl carbodenafil | Public Notification | Drugs |
|
| 05/16/2019 | Green Bali Powder | KratomNC | 925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335 | kratomnc.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 05/16/2019 | Red Indo Powder | KratomNC | 925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335 | kratomnc.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 05/16/2019 | Gold Bali Powder | KratomNC | 925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335 | kratomnc.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 05/16/2019 | White Indo Powder | KratomNC | 925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335 | kratomnc.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 05/16/2019 | Super White Powder | KratomNC | 925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335 | kratomnc.com | Unapproved New Drug/Misbranded | Warning Letter | Drugs |
|
| 05/15/2019 | Active Herb YinVive | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/15/2019 | Active Herb Ease Tonic | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/15/2019 | Active Herb LiverVive | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/15/2019 | Guang Ci Tang Vertigoff (Ban Xia Bai Zhu Tian Ma Pian) | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/15/2019 | Guang Ci Tang Nasopass (Bi Yan Pian) | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/15/2019 | Guang Ci Tang NeuroSoothe (Chai Hu Long Gu Lu Mu Li Pian (Wan) | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/15/2019 | Guang Ci Tang JointsJoy (Du Huo Ji Sheng Wan) | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/15/2019 | Guang Ci Tang Cardiovigor (Fu Fang Dan Shen Pian) | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/15/2019 | Guang Ci Tang Kudzu Relaxe (Ge Gen Tang Pian) | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/15/2019 | Guang Ci Tang Stomacare (Huo Xiang Zheng Qi Pian) | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/15/2019 | Guang Ci Tang Breathmooth (Ke Chuan Pian) | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/15/2019 | Guang Ci Tang Stonepass (Li Shui Pai Shi Pian) | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/15/2019 | Guang Ci Tang Bupleuri Relaxe (Xiao Chai Hu Pian (Wan) | ActiveHerb Technology, Inc. | 8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263 | activeherb.com | Unapproved New Drugs/Misbranded | Warning Letter | Foods |
|
| 05/07/2019 | Topical Sunscreen and Anti-Blemish Over-the-Counter (OTC) Drug Products | AMMD Labs, LLC | 1501 Green Rd Ste J, Pompano Beach, FL 33064 | n/a | CGMP/Finished Pharmaceuticals/Adulterated | Warning Letter | Drugs |
|
| 05/07/2019 | The BEAST Capsules | STIFF BOY LLC | n/a | n/a | Undeclared sildenafil | Recall | Drugs |
|
| 05/02/2019 | Puriton Eye Relief Drops | Kadesh International | 7341 Lincoln Way, Garden Grove, CA 92841 | puriton.us | CGMP/Finished Pharmaceuticals/Adulterated | Warning Letter | Drugs |
|
| 05/02/2019 | Puriton Intimate Disinfection Spray | Kadesh International | 7341 Lincoln Way, Garden Grove, CA 92841 | puriton.us | CGMP/Finished Pharmaceuticals/Adulterated | Warning Letter | Drugs |
|
| 04/23/2019 | Fever~Infection | Newton Laboratories Inc DBA Newton Homeopathics | 455 Gees Mill Business Ct. NE, Conyers, GA 30013 | newtonlabs.net | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Warning Letter | Drugs |
|
| 04/23/2019 | Food Allergies~Additives | Newton Laboratories Inc DBA Newton Homeopathics | 455 Gees Mill Business Ct. NE, Conyers, GA 30013 | newtonlabs.net | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Warning Letter | Drugs |
|
| 04/23/2019 | Blues~Mood~Emotions | Newton Laboratories Inc DBA Newton Homeopathics | 455 Gees Mill Business Ct. NE, Conyers, GA 30013 | newtonlabs.net | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Warning Letter | Drugs |
|
| 04/23/2019 | Vaccination~Illness | Newton Laboratories Inc DBA Newton Homeopathics | 455 Gees Mill Business Ct. NE, Conyers, GA 30013 | newtonlabs.net | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Warning Letter | Drugs |
|
| 04/09/2019 | Platinum 40000 | SD Imports, LLC | n/a | n/a | Undeclared sildenafil | Recall | Drugs |
|
| 04/05/2019 | Kopi Jantan Tradisional Natural Herbs Coffee | Brian Richardson dba In Tha Pink | n/a | n/a | Undeclared sildenafiland tadalafil | Recall | Drugs |
|
| 03/22/2019 | LEOPARD Miracle Honey | USA LESS | PO Box 250-138, Brooklyn, NY 11225 | n/a | Undeclared sildenafil | Recall | Drugs |
|
| 03/21/2019 | BLUEFUSION Capsules | Ata Int. Inc. | n/a | n/a | Undeclared sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein | Recall | Drugs |
|
| 02/08/2019 | Indian Herb | McDaniel Life-Line LLC | n/a | n/a | Marketed without an approved NDA/ANDA | Recall | Drugs |
|
| 01/29/2019 | Silver Bullet 10x | Nature's Rx | n/a | n/a | Undeclared sildenafil and tadalafil | Recall | Drugs |
|
| 01/28/2019 | GoLean Detox | GoLean Detox US | 4832 Central Ave, Charlotte, NC 28205-5844 | facebook.com/GoLean-detox-US-1592137147568285/ | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs | |
| 01/28/2019 | Ultra Fit | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and N-desmethylsibutramine | Public Notification | Drugs |
|
| 01/28/2019 | Slimmer Extreme Thermogenic Formula | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 01/28/2019 | Slim Bio Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine, N-desmethylsibutramine, sildenafil, tadalafil, benproperine and diphenhydramine | Public Notification | Drugs |
|
| 01/28/2019 | Slimina | Various Distributors | n/a | effectivehealthyproducts.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 01/28/2019 | Red Stallion Extra Strong | Various Distributors | n/a | International Mail Shipments | Undeclared tadalafil | Public Notification | Drugs |
|
| 01/28/2019 | Natural V=GRA | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 01/28/2019 | Yong Gang | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 01/28/2019 | Golden Ant | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 01/28/2019 | Instinct Best Sexual Enjoyment | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 01/28/2019 | Nectar Del Amor | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 01/10/2013 | 1 Day Diet | Various Distributors | n/a | n/a | Undeclared N-desmethylsibutramine | Public Notification | Drugs |
|
| 01/10/2019 | Black King Kong | Various Distributors | n/a | International Mail Shipments | Undeclared moroxydine and sildenafil | Public Notification | Drugs |
|
| 01/10/2019 | The Silver Bullet | Various Distributors | n/a | ebay.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 01/08/2019 | Rhino 5K | Happy Together, Inc. | 504 Muirfield Dr., Atlantis FL, 33462 | n/a | Undeclared sildenafil and tadalafil | Recall | Drugs |
|
| 12/10/2018 | On Demand | Various Distributors | n/a | goodlifeondemand.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/30/2018 | Willy Go Wild | Various Distributors | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 11/30/2018 | MOB Candy | Various Distributors | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 11/21/2018 | America Treasure | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/08/2018 | Memory Revitalizer | Alzheimer's Corporation (ALZcorp) | 6000 Uptown Blvd., NE Suite 308 Albuquerque, NM 87110 | lifeimagined.com; alzheimerscorp.com; memoryrevitalizer.com; alzcorp.com | New drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/08/2018 | Cerebara GPC (L-Alpha glycerophosphocholine) | Alzheimer's Corporation (ALZcorp) | 6000 Uptown Blvd., NE Suite 308 Albuquerque, NM 87110 | lifeimagined.com; alzheimerscorp.com; memoryrevitalizer.com; alzcorp.com | New drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/08/2018 | Life Imagined | Alzheimer's Corporation (ALZcorp) | 6000 Uptown Blvd., NE Suite 308 Albuquerque, NM 87110 | lifeimagined.com; alzheimerscorp.com; memoryrevitalizer.com; alzcorp.com | New drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/08/2018 | Mind and Memory Support | Alzheimer's Organization | 509 Riverside Drive, Suite 302 Stuart, FL 34994 | alzheimersorganization.org | New drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/08/2018 | Leopard Secret Miracle Honey | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/08/2018 | Best Leopard Miracle of Honey | Various Distributors | n/a | Examination of imported goods | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 11/08/2018 | Gold Max Blue | Various Distributors | n/a | goldmaxblue.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/07/2018 | BALI Greens | Dr. Fitt Intelligent Designs, LLC | 812 S Georgia St Amarillo, TX 79106 | drfitt.com; drfittinfo.com | New Drugs | Online Advisory Letter | Foods; Drugs | |
| 11/07/2018 | BALI Purples | Dr. Fitt Intelligent Designs, LLC | 812 S Georgia St Amarillo, TX 79106 | drfitt.com; drfittinfo.com | New Drugs | Online Advisory Letter | Foods; Drugs | |
| 11/07/2018 | Black Seed Oil | Dr. Fitt Intelligent Designs, LLC | 812 S Georgia St Amarillo, TX 79106 | drfitt.com; drfittinfo.com | New Drugs | Online Advisory Letter | Foods; Drugs | |
| 11/07/2018 | DHEA Capsules | Dr. Fitt Intelligent Designs, LLC | 812 S Georgia St Amarillo, TX 79106 | drfitt.com; drfittinfo.com | New Drugs | Online Advisory Letter | Foods; Drugs | |
| 11/07/2018 | Lugol’s Solution 2% Drops | Dr. Fitt Intelligent Designs, LLC | 812 S Georgia St Amarillo, TX 79106 | drfitt.com; drfittinfo.com | New Drugs | Online Advisory Letter | Foods; Drugs | |
| 11/07/2018 | Robenyzme Capsules | Dr. Fitt Intelligent Designs, LLC | 812 S Georgia St Amarillo, TX 79106 | drfitt.com; drfittinfo.com | New Drugs | Online Advisory Letter | Foods; Drugs | |
| 11/07/2018 | OMG Max Drops | Dr. Fitt Intelligent Designs, LLC | 812 S Georgia St Amarillo, TX 79106 | drfitt.com; drfittinfo.com | New Drugs | Online Advisory Letter | Foods; Drugs | |
| 11/07/2018 | New Dawn Capsules | Dr. Fitt Intelligent Designs, LLC | 812 S Georgia St Amarillo, TX 79106 | drfitt.com; drfittinfo.com | New Drugs | Online Advisory Letter | Foods; Drugs | |
| 11/07/2018 | Vitamin C with R-Lipoic Acid | Dr. Fitt Intelligent Designs, LLC | 812 S Georgia St Amarillo, TX 79106 | drfitt.com; drfittinfo.com | New Drugs | Online Advisory Letter | Foods; Drugs | |
| 11/07/2018 | Aromatherapy for Dementia Memory Kit Premier Edition | Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store | 340 Royal Poinciana Way, #317 Palm Beach, FL 33480 | alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/07/2018 | Aromatherapy for Dementia Memory Kit Second Edition | Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store | 340 Royal Poinciana Way, #317 Palm Beach, FL 33480 | alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/07/2018 | Bodyguard Blend Essential Oil | Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store | 340 Royal Poinciana Way, #317 Palm Beach, FL 33480 | alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/07/2018 | ClearMind Blend Essential Oil | Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store | 340 Royal Poinciana Way, #317 Palm Beach, FL 33480 | alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/07/2018 | Lavender Essential Oil | Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store | 340 Royal Poinciana Way, #317 Palm Beach, FL 33480 | alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/07/2018 | Attention Aromatherapy Patch | Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store | 340 Royal Poinciana Way, #317 Palm Beach, FL 33480 | alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/07/2018 | Calming Aromatherapy Patch | Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store | 340 Royal Poinciana Way, #317 Palm Beach, FL 33480 | alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/07/2018 | Lavender Aromatherapy Patch | Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store | 340 Royal Poinciana Way, #317 Palm Beach, FL 33480 | alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/07/2018 | Perk Up Aromatherapy Patch | Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store | 340 Royal Poinciana Way, #317 Palm Beach, FL 33480 | alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/07/2018 | Refresh Aromatherapy Patch | Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store | 340 Royal Poinciana Way, #317 Palm Beach, FL 33480 | alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/07/2018 | Rested Aromatherapy Patch | Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store | 340 Royal Poinciana Way, #317 Palm Beach, FL 33480 | alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/07/2018 | Aromatherapy Patch Sample Pack | Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store | 340 Royal Poinciana Way, #317 Palm Beach, FL 33480 | alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 11/07/2018 | Essential Oils including Dementia/Alzheimer's (Day) Synergy Oil and Dementia/Alzheimer's (Night) Synergy Oil | This Wonderful Life New Age Shop | M-0-7, Plaza Damas 60 Jalan Sri Hartamas 1 Kuala Lumpur, 50480 Malaysia MY | twlshop.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 10/15/2018 | Zero Xtreme | Fat Burners Zone | n/a | n/a | Undeclared sibutramine | Recall | Drugs |
|
| 10/01/2018 | FX75000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 10/01/2018 | Baschi Quick Slimming Capsule | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and N-desmethylsibutramine | Public Notification | Drugs |
|
| 10/01/2018 | In Shape | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 10/01/2018 | Like Slim Coffee | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 10/01/2018 | Shengan Natural Model | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 10/01/2018 | Green Lean Body Capsule | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and N-desmethylsibutramine | Public Notification | Drugs |
|
| 10/01/2018 | Strong Horses | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 10/01/2018 | USA for Woman | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 10/01/2018 | V-Max | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 10/01/2018 | ProSolution | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 09/06/2018 | Purblack | Adaptive Energy LLC | 109 E 17th St. Ste 4, Cheyenne, WY 82001 | purblack.com | New Drug/Misbranded | Warning Letter | Foods | |
| 08/31/2018 | Easy 2 Slim | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 08/31/2018 | Slimming Capsule | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 08/31/2018 | Extenze Nutritional Supplement | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 08/31/2018 | BodySlim Herbal | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 08/31/2018 | Extenze Plus | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 08/31/2018 | PremierZen Gold 4000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 08/31/2018 | 5K | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 08/31/2018 | Panther Power Platinum 11000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 08/31/2018 | Nuvitra | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and fluoxetine | Public Notification | Drugs |
|
| 08/31/2018 | XXXPlosion Ultra | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 08/29/2018 | Cell Stop | Optimal Health Knowledge LLC | 2177 NE 62nd Ct. Fort Lauderdale, FL 33308 | optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/ | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 08/29/2018 | Cardio Forte | Optimal Health Knowledge LLC | 2177 NE 62nd Ct. Fort Lauderdale, FL 33308 | optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/ | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 08/29/2018 | Inflam-Alieve | Optimal Health Knowledge LLC | 2177 NE 62nd Ct. Fort Lauderdale, FL 33308 | optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/ | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 08/29/2018 | Liv Assist | Optimal Health Knowledge LLC | 2177 NE 62nd Ct. Fort Lauderdale, FL 33308 | optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/ | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 08/29/2018 | Mindful | Optimal Health Knowledge LLC | 2177 NE 62nd Ct. Fort Lauderdale, FL 33308 | optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/ | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 08/29/2018 | GI Comfort | Optimal Health Knowledge LLC | 2177 NE 62nd Ct. Fort Lauderdale, FL 33308 | optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/ | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 08/29/2018 | Tranquil | Optimal Health Knowledge LLC | 2177 NE 62nd Ct. Fort Lauderdale, FL 33308 | optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/ | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 08/10/2018 | Ding Ji Wei Ge | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/31/2018 | Black Rhino 25000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/31/2018 | Gold Rhino 25000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/31/2018 | Boss Rhino 15000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/31/2018 | Platinum Rhino 25000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/31/2018 | Krazzy Rhino | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/16/2018 | Rhino 8 Platinum 8000 | Various Distributors | n/a | n/a | Undeclared N-desmethylsibutramine, phenolphthalein, diclofenac, and sildenafil | Public Notification | Drugs |
|
| 07/11/2018 | Platinum Maximum Strength Blue Pill Version | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sibutramine and phenolphthalein | Recall | Drugs | |
| 07/11/2018 | Slimming Plus Advanced Weight Loss | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sildenafil | Recall | Drugs | |
| 07/11/2018 | African Viagra | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sildenafil | Recall | Drugs | |
| 07/11/2018 | GINSENG | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sildenafil | Recall | Drugs | |
| 07/11/2018 | African Superman | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sildenafil | Recall | Drugs | |
| 07/11/2018 | Old Chinese | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sildenafil | Recall | Drugs | |
| 07/11/2018 | Lean Extreme Max | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sibutramine | Recall | Drugs | |
| 07/11/2018 | X-treme Beauty Slim | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sibutramine | Recall | Drugs | |
| 07/11/2018 | African Superman - Top-Class Permanence Tablet | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sildenafil | Recall | Drugs | |
| 07/11/2018 | Slim Evolution | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared diclofenac | Recall | Drugs | |
| 07/11/2018 | Fat Loss Slimming Beauty | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sibutramine and phenolphthalein | Recall | Drugs | |
| 07/11/2018 | Fruta Planta | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sibutramine and phenolphthalein | Recall | Drugs | |
| 07/11/2018 | Botanical Slimming | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared API | Recall | Drugs | |
| 07/11/2018 | Slim Body | MyNicNaxs, LLC | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared API | Recall | Drugs | |
| 07/09/2018 | Asunsa | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine, N-desmethylsibutramine, benzylsibutramine, phenolphthalein and diclofenac | Public Notification | Drugs |
|
| 07/09/2018 | C.U. Plus | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 07/09/2018 | Lyn DTOX FS3 | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and N-desmethylsibutramine | Public Notification | Drugs |
|
| 07/09/2018 | Dale Mas | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 07/09/2018 | Grakcu Capsule | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 07/09/2018 | Maximum Powerful | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/03/2018 | Body Shape Weight Loss | Various Distributors | n/a | International Mail Shipments | Undeclared phenolphthalein | Public Notification | Drugs |
|
| 07/03/2018 | Row of Antibody Pil | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 07/03/2018 | Chong Cao Qiang Shen Wang | Various Distributors | n/a | International Mail Shipments | Undeclared phenolphthalein | Public Notification | Drugs |
|
| 07/03/2018 | Adipotrim XT | Various Distributors | n/a | International Mail Shipments | Undeclared phenolphthalein | Public Notification | Drugs |
|
| 07/03/2018 | Maxidus | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/20/2018 | Gold Viagra | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/20/2018 | AB Slim | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine, phenolphthalein and sildenafil | Public Notification | Drugs |
|
| 06/20/2018 | Adriana Balance S | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 06/20/2018 | Black Stallion 35000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/20/2018 | XXXPlosion | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/07/2018 | PAYA Dietary Supplement Product | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 06/07/2018 | Crossroads Wellness Beverage | Up Inya Gear | 22 Centennial St., Fairfield, PA 17320 | crossroads2freeedom.com; upinyabeverages.com | New Drug/Misbranded | Warning Letter | Foods | |
| 05/18/2018 | Solaricare | Pharmacy Direct, PDU | 8 The Green, Suite 5871, Dover, DE 19901 | solaricare.com | New Drug/Labeling/Misbranded | Warning Letter | Foods | |
| 05/17/2018 | 7K | Shoreside Enterprises, Inc. | 6345 Newtown Circle A-3, Tampa, FL 33615 | n/a | Undeclared sildenafil and/or tadalafil | Recall | Drugs |
|
| 05/17/2018 | Poseidon 4500 (Extreme 1000 mg) | Shoreside Enterprises, Inc. | 6345 Newtown Circle A-3, Tampa, FL 33615 | n/a | Undeclared sildenafil and/or tadalafil | Recall | Drugs |
|
| 05/14/2018 | MediViral Extra Strength Herpes Treatment | MediViral, Inc | PO Box 56822 Los Angeles, CA 91413 | mediviral.com; twitter.com/mediviral | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | MediViral Extra Strength Herpes Topical Treatment | MediViral, Inc | PO Box 56822 Los Angeles, CA 91413 | mediviral.com; twitter.com/mediviral | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | Anti-Stroke | Olivia’s Healing Herbs | 1102 Edgefield St. Killeen, TX 75649-2112 | oliviashealingherbs.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | Bones | Olivia’s Healing Herbs | 1102 Edgefield St. Killeen, TX 75649-2112 | oliviashealingherbs.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | Viral-X | Olivia’s Healing Herbs | 1102 Edgefield St. Killeen, TX 75649-2112 | oliviashealingherbs.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | Candida | Olivia’s Healing Herbs | 1102 Edgefield St. Killeen, TX 75649-2112 | oliviashealingherbs.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | Iron Infusion | Olivia’s Healing Herbs | 1102 Edgefield St. Killeen, TX 75649-2112 | oliviashealingherbs.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | Mental Focus | Olivia’s Healing Herbs | 1102 Edgefield St. Killeen, TX 75649-2112 | oliviashealingherbs.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | Natural Cancer Fighter | Olivia’s Healing Herbs | 1102 Edgefield St. Killeen, TX 75649-2112 | oliviashealingherbs.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | Sugar Diabetes Control | Olivia’s Healing Herbs | 1102 Edgefield St. Killeen, TX 75649-2112 | oliviashealingherbs.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | Niagra | Olivia’s Healing Herbs | 1102 Edgefield St. Killeen, TX 75649-2112 | oliviashealingherbs.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | “Honey, I’m Home” Body Wash | Olivia’s Healing Herbs | 1102 Edgefield St. Killeen, TX 75649-2112 | oliviashealingherbs.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | “Ancient Healing Herbs” Body Wash | Olivia’s Healing Herbs | 1102 Edgefield St. Killeen, TX 75649-2112 | oliviashealingherbs.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | “Cinnamon Sensations” Body Wash | Olivia’s Healing Herbs | 1102 Edgefield St. Killeen, TX 75649-2112 | oliviashealingherbs.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 05/14/2018 | Best Candy | Various Distributors | n/a | Examination of Imported Goods | Undeclared nortadalafil | Public Notification | Drugs |
|
| 03/28/2018 | Black Lion Pill | Various Distributors | n/a | rakuten.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/28/2018 | Red Zone Xtreme 3000 | Various Distributors | n/a | ebay.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 03/28/2018 | Rhino 69 Extreme 50000 | AMA Wholesale Inc. | n/a | bonanza.com | Undeclared tadalafil | Public Notification | Drugs |
Recall |
| 03/28/2018 | Blue Pearl All Natural Male Enhancement Supplement | Marmex Corp | n/a | n/a | Undeclared sildenafil | Recall | Drugs |
|
| 12/06/2017 | After Gallbladder Removal Kit | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Beet Root Capsules | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | 30 Day Gallbladder Solution | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Bile Salts | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Choline | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Dissolve GS | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Gallbladder ND Detox | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Gallstone Kit | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Glutathione Liposomal Liquid | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Liver Detox Kit | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Liver ND Detox | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Peppermint Oil Capsules | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Tranquinol | Gallbladder Attack | n/a | gallbladderattack.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Prostalgene Oral Drops | Prostalgene LLC | n/a | prostalgene.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Shilajit Resin | Healthy Nutrition Group LLC | n/a | naturalshilajit.com; organicagsolutions.org | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | NutriHoney | Healthy Nutrition Group LLC | n/a | naturalshilajit.com; organicagsolutions.org | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Bulk Shilajit | Healthy Nutrition Group LLC | n/a | naturalshilajit.com; organicagsolutions.org | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Combination Herpes Treatment | Synergy Health Solutions | n/a | cure4herpes.com; treatment4herpes.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | L-Lysine | Synergy Health Solutions | n/a | cure4herpes.com; treatment4herpes.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Tribulus | Synergy Health Solutions | n/a | cure4herpes.com; treatment4herpes.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Astragalus | Synergy Health Solutions | n/a | cure4herpes.com; treatment4herpes.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Rhodiola | Synergy Health Solutions | n/a | cure4herpes.com; treatment4herpes.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Amino Acid Formula (or “Unique Amino Formula”) | Synergy Health Solutions | n/a | cure4herpes.com; treatment4herpes.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Curos Essential | Cura Care, Inc. | n/a | getcuros.com | New Drugs | Online Advisory Letter | Foods; Drugs |
|
| 12/06/2017 | Chill6 | Chill6 | 26 Valley Forge Cir. West Boylston, MA 01583 | chill6.com | Unapproved New Drugs/Misbranded | Online Advisory Letter | Drugs | |
| 11/30/2017 | Chao Jimengnan | Nutra Labs Inc. | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/30/2017 | Bull | Nutra Labs Inc. | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/22/2017 | Asia Slim Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine, diazepam, and bisacodyl | Public Notification | Drugs |
|
| 11/20/2017 | New Stiff Nights Platinum 10k | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | Pro Solution | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | Qibianli | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | Rhino 11 Platinum 11000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | Rhino 12 Titanium 6000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | Rhino 25K 15000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | Rhino 69 Premium 8000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | S.W.A.G. II Platinum 33K | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | V9 Male Sexual Stimulant | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | Tyrannosaurus | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | Fruta Planta Life (Garcinia Cambogia Premium) | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 11/20/2017 | Adipessum Miracle Slimming Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared fluoxetine | Public Notification | Drugs |
|
| 11/20/2017 | MenXtrong | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | Blue Diamond Pill | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | Control Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2017 | Blue Pearl All Natural Male Enhancement | Various Distributors | n/a | bluepearlformen.com; bluefusions.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/09/2017 | Hard Times for Men | Various Distributors | n/a | blankterrmall.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 10/30/2017 | Linsen Double Caulis Plus (靈仙双藤素) | Various Distributors | n/a | tranpharma.com | Undeclared dexamethasone | Public Notification | Drugs |
|
| 10/10/2017 | Tiger 5000 | Various Distributors | n/a | amazon.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 10/04/2017 | A1 Slim | Kiriko, LLC | Houston, TX | n/a | Undeclared sibutramine, phenolphthalein and N-Desmethyl sibutramine | Recall | Drugs |
|
| 09/20/2017 | Vegetable Vigra | Natures Supplement, Inc. | n/a | n/a | Undeclared sildenafil | Recall | Drugs |
|
| 09/20/2017 | Rhino 7 Platinum 5000 | Gadget Island, Inc. dba Gear Isle | n/a | gearisle.com | Undeclared sildenafil and tadalafil | Recall | Drugs | |
| 09/20/2017 | Papa Zen 3300 | Gadget Island, Inc. dba Gear Isle | n/a | gearisle.com | Undeclared sildenafil and tadalafil | Recall | Drugs | |
| 09/20/2017 | Fifty Shades 6000 | Gadget Island, Inc. dba Gear Isle | n/a | gearisle.com | Undeclared sildenafil and tadalafil | Recall | Drugs | |
| 09/20/2017 | Grande X 5800 | Gadget Island, Inc. dba Gear Isle | n/a | gearisle.com | Undeclared sildenafil and tadalafil | Recall | Drugs | |
| 08/31/2017 | Physic Candy - Define | Various Distributors | n/a | physic-candy.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 08/31/2017 | Physic Candy - Curve | Various Distributors | n/a | physic-candy.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 08/01/2017 | AMPT Coffee | The AMPT Life, LLC | n/a | amptcoffee.com | Undeclared sildenafil, tadalafil and milk | Public Notification | Drugs |
|
| 07/24/2017 | Xplode | EZ Weight Loss TX | Corpus Christi, TX | n/a | Undeclared sibutramine | Recall | Drugs |
|
| 07/24/2017 | La Bri's Body Health Atomic | EZ Weight Loss TX | Corpus Christi, TX | n/a | Undeclared sibutramine | Recall | Drugs |
|
| 07/17/2017 | Kingdom Honey for Him | Various Distributors | n/a | International Mail Shipments | Undeclared tadalafil | Public Notification | Drugs |
|
| 07/17/2017 | Kingdom Honey for Her | Various Distributors | n/a | International Mail Shipments | Undeclared tadalafil | Public Notification | Drugs |
|
| 07/17/2017 | Royal Honey VIP | Various Distributors | n/a | International Mail Shipments | Undeclared tadalafil | Public Notification | Drugs |
|
| 07/17/2017 | RHINO 7 Platinum 5000 | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/29/2017 | Agony Balm | Hart & Soul Herbal, LLC | n/a | hartandsoulherbal.com | New Drugs | Online Advisory Letter | Drugs |
|
| 06/29/2017 | Auburn Oil | Hart & Soul Herbal, LLC | n/a | hartandsoulherbal.com | New Drugs | Online Advisory Letter | Drugs |
|
| 06/29/2017 | Rose of Sharon Salt/Olive Soap | Hart & Soul Herbal, LLC | n/a | hartandsoulherbal.com | New Drugs | Online Advisory Letter | Drugs |
|
| 06/29/2017 | Mudd Bombs | Hart & Soul Herbal, LLC | n/a | hartandsoulherbal.com | New Drugs | Online Advisory Letter | Drugs |
|
| 06/29/2017 | Harmony Castile Soap | Hart & Soul Herbal, LLC | n/a | hartandsoulherbal.com | New Drugs | Online Advisory Letter | Drugs |
|
| 06/29/2017 | Rouse Oil | Hart & Soul Herbal, LLC | n/a | hartandsoulherbal.com | New Drugs | Online Advisory Letter | Drugs |
|
| 06/29/2017 | Dew of the Sea Salt/Olive Soap | Hart & Soul Herbal, LLC | n/a | hartandsoulherbal.com | New Drugs | Online Advisory Letter | Drugs |
|
| 06/29/2017 | Season Infusions | Hart & Soul Herbal, LLC | n/a | hartandsoulherbal.com | New Drugs | Online Advisory Letter | Drugs |
|
| 06/29/2017 | Serenity Castile Soap | Hart & Soul Herbal, LLC | n/a | hartandsoulherbal.com | New Drugs | Online Advisory Letter | Drugs |
|
| 06/29/2017 | PD Complete | ARS Therapeutics, LLC | n/a | alstreatments.com | New Drugs | Online Advisory Letter | Drugs |
|
| 06/29/2017 | ALS Complete | ARS Therapeutics, LLC | n/a | alstreatments.com | New Drugs | Online Advisory Letter | Drugs |
|
| 06/23/2017 | XXX Zone Platinum | SHH Trading | n/a | n/a | Undeclared sildenafil, tadalafil and dapoxetine | Public Notification | Drugs |
|
| 06/23/2017 | Triple X 2000 | SHH Trading | n/a | n/a | Undeclared tadalafil and dapoxetine | Public Notification | Drugs |
|
| 06/23/2017 | Triple Premium Zen Gold 1300mg | SHH Trading | n/a | n/a | Undeclared sildenafil, tadalafil and dapoxetine | Public Notification | Drugs |
|
| 06/23/2017 | Macho Man 3000 | SHH Trading | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 06/22/2017 | Monster X 1350 | SHH Trading | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 06/22/2017 | Own the Knight 1750 | SHH Trading | n/a | n/a | Undeclared tadalafil and dapoxetine | Public Notification | Drugs |
|
| 06/22/2017 | Royal Master 1500 | SHH Trading | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 06/22/2017 | Triple Miracle Zen Plus 1200mg | SHH Trading | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 06/22/2017 | Xzone Gold | SHH Trading | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 06/22/2017 | Man of Steel 2 | Various Distributors | n/a | manofsteelpills.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/22/2017 | Man of Steel | Various Distributors | n/a | manofsteelpills.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/22/2017 | Love Zen 3000 | Various Distributors | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 06/22/2017 | Super Panther 7K | Various Distributors | n/a | ultraxshop.com | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 05/25/2017 | Caverflo Natural Herbal Coffee | Caverflo.com | n/a | caverflo.com | Undeclared sildenafil, tadalafil, and milk | Recall | Drugs |
|
| 04/18/2017 | Uproar | Organic Herbal Supply, Inc. | n/a | amazon.com; zrect.com | Undeclared tadalafil, sildenafil and their analogues | Recall | Drugs |
|
| 04/18/2017 | Cummor | Organic Herbal Supply, Inc. | n/a | amazon.com; zrect.com | Undeclared tadalafil, sildenafil and their analogues | Recall | Drugs |
|
| 04/18/2017 | Zrect | Organic Herbal Supply, Inc. | n/a | amazon.com; zrect.com | Undeclared tadalafil, sildenafil and their analogues | Recall | Drugs |
|
| 04/18/2017 | Monkey Business | Organic Herbal Supply, Inc. | n/a | amazon.com; zrect.com | Undeclared tadalafil, sildenafil and their analogues | Recall | Drugs |
|
| 04/18/2017 | Xrect | Organic Herbal Supply, Inc. | n/a | amazon.com; zrect.com | Undeclared tadalafil, sildenafil and their analogues | Recall | Drugs |
|
| 04/18/2017 | Rectalis | Organic Herbal Supply, Inc. | n/a | amazon.com; zrect.com | Undeclared tadalafil, sildenafil and their analogues | Recall | Drugs |
|
| 04/18/2017 | Tornado | Organic Herbal Supply, Inc. | n/a | amazon.com; zrect.com | Undeclared tadalafil, sildenafil and their analogues | Recall | Drugs |
|
| 04/18/2017 | Zdaily | Organic Herbal Supply, Inc. | n/a | amazon.com; zrect.com | Undeclared tadalafil, sildenafil and their analogues | Recall | Drugs |
|
| 04/18/2017 | BigNHard | Organic Herbal Supply, Inc. | n/a | amazon.com; zrect.com | Undeclared tadalafil, sildenafil and their analogues | Recall | Drugs |
|
| 04/18/2017 | Enhancerol Natural Male Enhancement capsules | Organic Herbal Supply, Inc. | n/a | amazon.com; zrect.com | Undeclared tadalafil, sildenafil and their analogues | Recall | Drugs |
|
| 04/18/2017 | Zrect for Women | Organic Herbal Supply, Inc. | n/a | amazon.com; zrect.com | Undeclared flibanserin | Recall | Drugs |
|
| 04/18/2017 | LabidaMAX capsules | Organic Herbal Supply, Inc. | n/a | amazon.com; zrect.com | Undeclared flibanserin | Recall | Drugs |
|
| 03/27/2017 | LaBri’s Body Health Atomic | Envy Me | n/a | n/a | Undeclared sibutramine | Recall | Drugs |
|
| 03/07/2017 | Black Ant | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Indian God Lotion | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Evil Root | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Germany Black Gold | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Germany Niubian | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Hard Ten Days | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Lang Yi Hao (Chaonogsuopian) | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Gold Vigra | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Clalis | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Ye Lang Shen | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Zhansheng Weige Chaoyue Xilishi | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Zhonghua Niubian | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Stree Overlord | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Max Man | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Hu Hu Sheng Wei | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Tiger King | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Viagra 100 | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Power V8 Viagra | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Daidiyongshi Xiangganglongshengwu | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Lien Chan for Seven Days | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/07/2017 | Maca Gold | A&H Focal Inc. | n/a | n/a | Undeclared PDE-5 Inhibitors | Recall | Drugs |
|
| 03/03/2017 | Arouse-Plus | Various Distributors | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 03/03/2017 | Bazook Bullet | Various Distributors | n/a | n/a | Undeclared aminotadalafil | Public Notification | Drugs |
|
| 02/03/2017 | Platinum Max Strength Blue Pill Version | Various Distributors | n/a | n/a | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 02/03/2017 | Ginseng for Reinforcing Kidney | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/03/2017 | Goldreallas Original | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/03/2017 | Platinum Weight Solution – Fat Loss Metabolizer | Various Distributors | n/a | n/a | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 02/03/2017 | Slimming Plus Advanced | Various Distributors | n/a | n/a | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 02/02/2017 | X-treme Beauty Slim | Various Distributors | n/a | n/a | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 02/02/2017 | Goldreallas XXX | Various Distributors | n/a | groupon.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/02/2017 | Shenjingpian | Various Distributors | n/a | ghpnutrition.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/02/2017 | Old Chinese | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/02/2017 | Lean Extreme Max | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 01/26/2017 | XtraHRD Natural Male Enhancement capsules | Organic Herbal Supply, Inc. | n/a | amazon.com | Undeclared N-desmethyl tadalafil | Public Notification | Drugs | |
| 01/10/2017 | PNC-27 | Patrick, LLC | NV | pnc27.com | Contaminated with the bacteria Variovorax paradoxus; contaminated with the bacteria Ralstonia insidiosa | Drug Safety Alert | Drugs | |
| 12/22/2016 | Rhino 8 Platinum 8000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | Lang Yi Hao | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | Power Male Sexual Stimulant | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | African Viagra | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | Triple Green Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | Queen Slimming Soft Gel | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 12/22/2016 | Big Penis Male Sexual Stimulant | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | 90° Jiushidu Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | Rhino 9 Premium 3500 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | Duramaxxx | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | Rhino 7K 9000 Male Performance Booster | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | Bl4ck 4K Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | Black 3K Plus Male Sexual Enhancement Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | Black Mamba 2 Premium Male Sexual Stimulant | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/22/2016 | Rhino 5 1500 Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/29/2016 | Megajex Natural Male Sex Enhancer | MS Bionic, Inc. | 447 E Gardena Blvd, Gardena, CA 90248-2913 | n/a | Undeclared tadalafil and sildenafil | Recall | Drugs | |
| 11/16/2016 | ABX Weight Loss | Various Distributors | n/a | zxtbeepollenpills.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 11/09/2016 | Supreme Slim 5.7 | Various Distributors | n/a | absolutenaturalweightloss.net | Undeclared phenolphthalein and sildenafil | Public Notification | Drugs |
|
| 11/09/2016 | Ready Man! | Various Distributors | n/a | amazon.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/07/2016 | Ultimate Body Tox PRO | Ultimate Body–Tox | High Point, NC | ultimatebodytox.com | Undeclared sibutramine | Public Notification | Drugs | |
| 10/19/2016 | Accelerator Boost | Various Distributors | n/a | n/a | Undeclared phenolphthalein | Public Notification | Drugs |
|
| 10/19/2016 | Skinny Bee Diet | Various Distributors | n/a | lovemytrubody.com | Undeclared desmethylsibutramine, sibutramine, and phenolphthalein | Public Notification | Drugs |
|
| 10/19/2016 | Zi Su Body Fat Health II (紫苏瘦身营养素 II) | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 10/19/2016 | Results | Various Distributors | n/a | facebook.com | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 09/16/2016 | Stiff Bull Herbal Coffee | Various Distributors | n/a | International Mail Shipments | Undeclared desmethyl carbodenafil | Public Notification | Drugs |
|
| 08/30/2016 | Kopi Jantan Tradisional Natural Herbs Coffee | Bestherbs Coffee LLC | 4250 Claremont Dr, Grand Priarie, TX 75052 | n/a | Undeclared desmethyl carbodenafil | Public Notification | Drugs | |
| 08/16/2016 | Master Zone 1500 | Various Distributors | n/a | amazon.com | Undeclared sildenafil and tadalfil | Public Notification | Drugs |
|
| 08/16/2016 | Love4Long | Various Distributors | n/a | amazon.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 08/16/2016 | One More Knight 1750 | Various Distributors | n/a | amazon.com | Undeclared tadalfil and dapoxetine | Public Notification | Drugs |
|
| 07/11/2016 | Dream Body Original Formula | Dream Body Weight Loss | Grand Prairie, TX | dreambodyweightloss.com | Undeclared sibutramine | Public Notification | Drugs | |
| 08/09/2016 | Adelgazantes R-II | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 08/09/2016 | Anaconda Strong Formula | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 08/09/2016 | Boss-Rhino Gold X-tra Strength | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 08/09/2016 | De Guo Hei Bei (徳国黑倍) | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/29/2016 | Ziyinzhuangyang | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/28/2016 | Zi Xiu Tang Beauty Face & Figure Capsule | Various Distributors | n/a | International Mail Shipments | Undeclared phenolphthalein and fluoxetine | Public Notification | Drugs |
|
| 07/28/2016 | Weili (一炮到天亮 or Yi Pao Dao Tian Liang) | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/28/2016 | Ultimate Lean | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and desmethylsibutramine | Public Notification | Drugs |
|
| 07/27/2016 | Mang Luk Power Slim | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/27/2016 | Libigirl | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/27/2016 | Maxx Easy | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/27/2016 | Mang Luk Power Slim | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/27/2016 | Power Spring (XXX) Oral Liquid | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/27/2016 | Super Bull 6000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/27/2016 | Slim Fit X | Various Distributors | n/a | jerseyshoresupplements.com | Undeclared sibutramine and desmethylsibutramine | Public Notification | Drugs |
|
| 07/27/2016 | Shangai Ultra X | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/27/2016 | The Golden Root | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/27/2016 | Super Shangai | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/22/2016 | Xcelerated Weight Loss Charged Up | Various Distributors | n/a | xceleratedweightloss.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/22/2016 | Xcelerated Weight Loss Turbo Charge | Various Distributors | n/a | xceleratedweightloss.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/22/2016 | Xcelerated Weight Loss Ultra Max | Various Distributors | n/a | xceleratedweightloss.com | Undeclared phenolphthalein and sildenafil | Public Notification | Drugs |
|
| 07/11/2016 | Extra Slim Plus Acai Berry Weight Loss Formula | Various Distributors | n/a | dreambodyweightloss.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/11/2016 | Dream Body Advanced + Acai Weight Loss & Cleanse | Various Distributors | Grand Prairie, TX | dreambodyweightloss.com | Undeclared sibutramine, fluoxetine and sildenafil | Public Notification | Drugs |
Recall |
| 07/11/2016 | Dream Body Extreme Gold | Dream Body Weight Loss | Grand Prairie, TX | dreambodyweightloss.com | Undeclared sibutramine, fluoxetine and sildenafil | Public Notification | Drugs |
Recall |
| 07/11/2016 | SBF Bee Pollen | Various Distributors | n/a | zxtbeepollen.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 06/07/2016 | Step 2 | The Body Shot Bar | n/a | thebodyshotbar.com | Undeclared sibutramine | Public Notification | Drugs |
Recall |
| 06/30/2016 | My Steel Woody | Various Distributors | n/a | mysteelwoody.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/06/2016 | Exhilarate | Various Distributors | n/a | n/a | Undeclared sibutramine, desmethylsibutramine, and phenolphthalein | Public Notification | Drugs |
|
| 06/01/2016 | DR’s Secret Bio Herbs Coffee | Various Distributors | n/a | International Mail Shipments | Undeclared tadalafil | Public Notification | Drugs |
|
| 04/26/2016 | 3rd Degree | Making It A Lifestyle, L.L.C. | Corpus Christi, TX | makingitalifestyle.com | Undeclared sibutramine | Public Notification | Drugs |
Recall |
| 04/26/2016 | Black Label X | Making It A Lifestyle, L.L.C. | Corpus Christi, TX | makingitalifestyle.com | Undeclared sildenafil | Public Notification | Drugs |
Recall |
| 04/26/2016 | Black Gold X Advanced | Making It A Lifestyle, L.L.C. | Corpus Christi, TX | makingitalifestyle.com | Undeclared sibutramine | Public Notification | Drugs |
Recall |
| 03/29/2016 | Propell Platinum | Various Distributors | n/a | zxtbeepollenpills.com | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 03/28/2016 | ENVY BP | Various Distributors | n/a | purelysimpleweightloss.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 03/17/2016 | Salute Capsules | Various Distributors | n/a | n/a | Undeclared sildenafil, thiosildenafil, and sulfoaildenafil | Public Notification | Drugs |
|
| 03/17/2016 | Xerophagy | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 03/17/2016 | ZlimXter Capsules | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/17/2016 | Dynamizm Capsules | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification |
|
|
| 03/17/2016 | Eradicate Capsules | Various Distributors | n/a | x2zero.com | Undeclared sibutramine and desmethylsibutramine | Public Notification | Drugs |
|
| 03/03/2016 | Sextra | Various Distributors | n/a | ishopLSTV.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/11/2016 | Zhong Hua Niu Bian | Various Distributors | n/a | zhonghuaniubian.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/11/2016 | Weekend Prince | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/11/2016 | Bull | Various Distributors | n/a | bullsexpills.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/11/2016 | Bull's Genital | Various Distributors | n/a | bullsgenital.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/05/2016 | Ninja-X | Various Distributors | n/a | n/a | Undeclared sildenafil and thiosildenafil | Public Notification | Drugs |
|
| 02/05/2016 | Golden Night | Various Distributors | n/a | n/a | Undeclared sildenafil and hydroxythiohomosildenafil | Public Notification | Drugs |
|
| 02/05/2016 | Ginseng Power-X | Various Distributors | n/a | n/a | Undeclared sildenafil and sulfoaildenafil | Public Notification | Drugs |
|
| 02/05/2016 | Boss Number #Six | Various Distributors | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 02/05/2016 | Mamba is Hero | Various Distributors | n/a | n/a | Undeclared sildenafil, desmethyl carbodenafil, and dapoxetine | Public Notification | Drugs |
|
| 01/26/2016 | Wonder-Erect Male Pills | Various Distributors | n/a | amazon.com | Undeclared vardenafil | Public Notification | Drugs |
|
| 01/21/2016 | Wonder-Erect Male Gum | Various Distributors | n/a | amazon.com | Undeclared vardenafil | Public Notification | Drugs |
|
| 12/28/2015 | Xtra Zone 2400 | Various Distributors | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 12/28/2015 | Triple MiracleZen Extreme 1750mg | Various Distributors | n/a | n/a | Undeclared sildenafil, tadalafil and dapoxetine | Public Notification | Drugs |
|
| 12/28/2015 | Eros Power Zone 1900 | Various Distributors | n/a | n/a | Undeclared desmethyl carbodenafil and dapoxetine | Public Notification | Drugs |
|
| 12/28/2015 | Triple MiracleZen Gold 1750mg | Various Distributors | n/a | n/a | Undeclared sildenafil, tadalafil and dapoxetine | Public Notification | Drugs |
|
| 12/28/2015 | Rhino Big Horn 3000 | Various Distributors | n/a | n/a | Undeclared desmethyl carbodenafil and sildenafil | Public Notification | Drugs |
|
| 12/28/2015 | Rhino 7 Blue 9000 | Various Distributors | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 12/28/2015 | OrgaZen 3000 | Various Distributors | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 12/28/2015 | Diamond 3500 | Various Distributors | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 12/28/2015 | Xtra Zone 2200 | Various Distributors | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 12/28/2015 | Xtra Zone 2600 | Various Distributors | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 12/28/2015 | Triple Power Zen Plus 2000 | Various Distributors | n/a | n/a | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 12/28/2015 | OrgaZen 3500 | Various Distributors | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 12/21/2015 | La'Trim Plus | Various Distributors | n/a | bee-xtreme.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 12/19/2015 | Super Herbs | Various Distributors | n/a | mysuperherbs.com | Undeclared sibutramine and desmethylsiburamine | Public Notification | Drugs |
|
| 12/18/2015 | Jenesis | Various Distributors | n/a | beeextremelyamazed.com; beefitamy.com | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 12/18/2015 | Oasis Bee Pollen | Various Distributors | n/a | beeextremelyamazed.com; beefitamy.com | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 12/18/2015 | Prime Bee Pollen | Various Distributors | n/a | beeextremelyamazed.com; beefitamy.com | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 12/18/2015 | Evolve Bee Pollen | Various Distributors | n/a | beeextremelyamazed.com; beefitamy.com | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 12/18/2015 | X Again Platinum | Various Distributors | n/a | paramount-supplements.com | Undeclared sildenafil, tadalafil and dapoxetine | Public Notification | Drugs |
|
| 12/17/2015 | Thirty Plus | Various Distributors | n/a | getskinny.bigcartel.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 12/17/2015 | Power Tiger-X | Various Distributors | n/a | everestwholesales.com | Undeclared sulfoaildenafil | Public Notification | Drugs |
|
| 12/09/2015 | Pink Bikini | Lucy's Weight Loss System | Arlington, TX | pink.bikini.bigcartel.com | Undeclared diclofenac | Recall | Drugs |
|
| 12/02/2015 | Lipo Escultura | Various Distributors, including JAT Productos Naturales Corp. | n/a | lipoesculturatreatment.com | Undeclared sibutramine and diclofenac | Public Notification | Drugs | |
| 11/19/2015 | Zero Fat | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and fluoxetine | Public Notification | Drugs |
|
| 11/19/2015 | Effective Viagra Tablets | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/19/2015 | Slyn Both | Various Distributors | n/a | International Mail Shipments | Undeclared fluoxetine and orlistat | Public Notification | Drugs |
|
| 11/19/2015 | Super Herbs | Various Distributors | n/a | mysuperherbs.com | Undeclared sibutramine and desmethylsiburamine | Public Notification | Drugs |
|
| 11/19/2015 | Rhino X | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/19/2015 | SPCARET Princess Diet | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 11/19/2015 | Perfect Slim Fast Track Slim | Various Distributors | n/a | International Mail Shipments | Undeclared fluoxetine and orlistat | Public Notification | Drugs |
|
| 11/19/2015 | Australia Kangaroo Essence | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/19/2015 | Sex Drive Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/19/2015 | XForMan Plus | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 10/29/2015 | Rhino 7 3000 | National Video Supply | 21100 Centre Pointe Park Way, Santa Clarita, CA 91350 | n/a | Undeclared desmethyl carbondenafil and dapoxetine | Recall | Drugs |
|
| 10/29/2015 | Rhino 7 Platinum 3000 | National Video Supply | 21100 Centre Pointe Park Way, Santa Clarita, CA 91350 | n/a | Undeclared desmethyl carbondenafil and dapoxetine | Recall | Drugs |
|
| 10/28/2015 | Rhino 7 3000 | Premiere Sales Group | 21446 Golden Triangle Rd., Santa Clarita, CA 91350 | n/a | Undeclared desmethyl carbondenafil and dapoxetine | Recall | Drugs |
|
| 10/28/2015 | Rhino 7 Platinum 3000 | Premiere Sales Group | 21446 Golden Triangle Rd., Santa Clarita, CA 91350 | n/a | Undeclared desmethyl carbondenafil and dapoxetine | Recall | Drugs | |
| 10/23/2015 | Fuel Up Plus | Reesna Inc. | Canoga Park, CA | fueluppills.com | Undeclared hydroxythiohomosildenafil | Public Notification | Drugs | |
| 10/23/2015 | Fuel Up High Octane | Reesna Inc. | Canoga Park, CA | fueluppills.com | Undeclared hydroxythiohomosildenafil | Public Notification | Drugs | |
| 10/23/2015 | S.W.A.G.G.E.R Extreme Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 10/23/2015 | Lishou Slimming Coffee | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 10/23/2015 | Xtreme Fat Burner Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared phenolphthalein and sildenafil | Public Notification | Drugs |
|
| 10/23/2015 | Tip-Top Shape | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 10/23/2015 | Wild Sexx Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil and tadalafil | Public Notification | Drugs |
|
| 10/23/2015 | Sex-Love Secret Code Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 10/23/2015 | APEXXX | Various Distributors | n/a | ebay.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 10/23/2015 | Ultra SX Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 10/23/2015 | Super Dragon 6000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 10/23/2015 | Paradise Suplemento Natural Ultra Plus Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 10/23/2015 | Basha Nut 100% Fruit Soft Gel Capsules | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 10/09/2015 | Rhino 7 3000 | TF Supplements | 6666 Gulf Freeway, Houston, TX | International Mail Shipments | Undeclared desmethyl carbondenafil and dapoxetine | Recall | Drugs |
|
| 10/09/2015 | Rhino 7 Platinum 3000 | TF Supplements | 6666 Gulf Freeway, Houston, TX | International Mail Shipments | Undeclared desmethyl carbondenafil and dapoxetine | Recall | Drugs |
|
| 10/01/2015 | NATUREAL | Various Distributors | n/a | naturealfs.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 10/01/2015 | Ultimate Herbal Slimcap | Various Distributors | n/a | fitfirmandfabulous.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 09/23/2015 | Shorts on the Beach Blue and Gold Edition | Lucy's Weight Loss System | n/a | n/a | Undeclared sibutramine and phenolphthalein | Recall | Drugs |
|
| 09/23/2015 | Pink Bikini | Lucy's Weight Loss System | n/a | n/a | Undeclared sibutramine and phenolphthalein | Recall | Drugs |
|
| 09/11/2015 | Miracle Diet 30 | The One Minute Miracle Inc. | 3322 NE 166 Street, North Miami Beach, FL 33160 | n/a | Undeclared phenolphthalein | Recall | Drugs | |
| 09/11/2015 | Miracle Diet 48 | The One Minute Miracle Inc. | 3322 NE 166 Street, North Miami Beach, FL 33160 | n/a | Undeclared thiosildenafil | Recall | Drugs | |
| 09/04/2015 | Vimax | Various Distributors | n/a | International Mail Shipments | Undeclared tadalafil | Public Notification | Drugs |
|
| 09/04/2015 | Meizi Super Power Fruits Herbal Slimming Formula | Various Distributors | n/a | slimeast.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 08/06/2015 | Kaboom Actions Strip 12 Pack | Blue Square Market Inc. | North Huntingdon, PA | calcompnutrition.com | Undeclared sulfoaildenafil | Recall | Drugs |
|
| 08/06/2015 | LiDa DaiDaiHua | Blue Square Market Inc. | North Huntingdon, PA | calcompnutriton.com | Undeclared sibutramine and phenolphthalein | Recall | Drugs |
|
| 08/06/2015 | Achieving Zero | Various Distributors | n/a | amazon.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/02/2015 | Akttive Capsules | Life & More, L.L.C. | Miami, FL | akttive.com | Undeclared sibutramine, desmethylsibutramine, and phenolphthalein | Public Notification | Drugs | |
| 07/02/2015 | Zero Xtreme | Fat Burners Zone | n/a | zeroxtremeusa.com | Undeclared sibutramine and desmethylsibutramine | Public Notification | Drugs | |
| 06/12/2015 | Pyrola | G&C Natural Nutrition, Inc, | Fullerton, CA | N/A | Undeclared diclofenac | Recall | Drugs |
|
| 06/05/2015 | Pyrola Advanced Joint Formula | Various Distributors | n/a | amazon.com | Undeclared diclofenac | Public Notification | Drugs |
|
| 06/05/2014 | Zhen Gong Fu | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/03/2015 | Smart Lipo | SmartLipo365 and Centro Naturista | 2915 East Division Street, Suite 523, Arlington, TX76011 | smartlipo365.com | Undeclared sibutramine, desmethylsibutramine, and phenolphthalein | Recall | Drugs | |
| 05/12/2015 | Slim Xtreme Diamond | Globe All Wellness | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 05/12/2015 | Slim Xtreme Platinum | Globe All Wellness | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 05/04/2015 | Jianbu Huqian Wan | Various Distributors | n/a | International Mail Shipments | Undeclared dexamethasone, chlorpheniramine, and furosemide | Public Notification | Drugs |
|
| 05/04/2015 | Saurean Fong Sep Lin | Various Distributors | n/a | International Mail Shipments | Undeclared dexamethasone and cyproheptadine | Public Notification | Drugs |
|
| 05/04/2015 | Asihuri Plus Forte | Various Distributors | n/a | International Mail Shipments | Undeclared dexamethasone and phenylbutazone | Public Notification | Drugs |
|
| 05/04/2015 | Ginseng She Lian Wan | Various Distributors | n/a | International Mail Shipments | Undeclared dexamethasone and chlorpheniramine | Public Notification | Drugs |
|
| 04/30/2015 | King of Romance | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 04/30/2015 | Viagra 007 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 04/30/2015 | Slim Forte Slimming Capsule | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 04/30/2015 | Li Da Dai Dai Hua Slimming Capsule | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 04/30/2015 | Black Panther | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 04/29/2015 | Fatloss Slimming Beauty | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 04/29/2015 | Superior | Various Distributors | n/a | detoxtheweightaway.com; beeallnatural.net | Undeclared sibutramine | Public Notification | Drugs |
|
| 09/12/2014 | Mezo | Various Distributors | n/a | n/a | Undeclared benzylsibutramine | Public Notification | Drugs |
|
| 04/21/2015 | Extreme Diamond 3000 | Various Distributors | n/a | libidoshops.com | Undeclared desmethyl carbodenafil and dapoxetine | Public Notification | Drugs |
|
| 03/26/2015 | Green Algae Combination | Crane Beauty | n/a | International Mail Shipments | Undeclared lorcaserin | Public Notification | Drugs |
|
| 03/18/2015 | Xcel Advanced | Various Distributors | n/a | beenaturalnutrition.com | Undeclared phenolphthalein | Public Notification | Drugs |
|
| 03/18/2015 | Ultimate Boost | Various Distributors | n/a | sportnutrition1.com | Undeclared phenolphthalein | Public Notification | Drugs |
|
| 03/18/2015 | Xcel | Various Distributors | n/a | zixiutangforyourfigure.com | Undeclared fluoxetine | Public Notification | Drugs |
|
| 03/18/2015 | Xcel Advanced | Various Distributors | n/a | beenaturalnutrition.com | Undeclared phenolphthalein | Public Notification | Drugs |
|
| 03/10/2015 | UltraZx | UltraZx, Labs, L.L.C. | n/a | n/a | Undeclared sibutramine and phenolphthalein | Recall | Drugs |
|
| 03/05/2015 | Black Mamba Premium | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/05/2015 | Black Mamba Hyperrush | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 03/05/2015 | African Superman | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/05/2015 | L-Carnitine Sob Strengthening Version Slimming Miracle Capsule | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 03/05/2015 | Black Ant King | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/05/2015 | Bigger Longer More Time More Sperms | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/03/2015 | Herb Viagra | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/03/2015 | Natural Max Slimming | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil, fluoxetine and sibutramine | Public Notification | Drugs |
|
| 03/03/2015 | Diablos Eca Fire Caps | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil, phenolphthalein, sibutramine and an analogue of sibutramine, deisobutylbenzylsibutramine | Public Notification | Drugs |
|
| 03/03/2015 | Stiff Nights | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/03/2015 | Male Silkworm Moth Nourishing Oral Liquid | Various Distributors | n/a | International Mail Shipments | Undeclared vardenafil | Public Notification | Drugs |
|
| 03/03/2015 | Baolong | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/03/2015 | Rhino Blitz Gold 3000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/03/2015 | Vim-25 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/02/2015 | MME MAXMAN | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/02/2015 | FX3000 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/02/2015 | Hard Wang | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/02/2015 | Vigour 300 | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/02/2015 | Santi Scalper | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/02/2015 | Plant Vigra | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/02/2015 | Vigra | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/02/2015 | Elimulating Weight & Toxin Keeping Beauty | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine | Public Notification | Drugs |
|
| 03/02/2015 | Super Hard | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 03/02/2015 | Sex Men | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/28/2015 | Seven Slim | Various Distributors | n/a | International Mail Shipments | Undeclared phenolphthalein | Public Notification | Drugs |
|
| 02/28/2015 | Night Man | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/28/2015 | Libigrow XXX Treme | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/28/2015 | Nine Slim | Various Distributors | n/a | International Mail Shipments | Undeclared phenolphthalein | Public Notification | Drugs |
|
| 02/28/2015 | Oxy ELITE Pro Super Thermogenic | Various Distributors | n/a | International Mail Shipments | Undeclared fluoxetine | Public Notification | Drugs |
|
| 02/27/2015 | 72HP | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/27/2015 | Tibet Babao | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/27/2015 | Germany Niubian | Various Distributors | n/a | International Mail Shipments | Undeclared sildenafil | Public Notification | Drugs |
|
| 02/27/2015 | Botanical Slimming (Red) | Various Distributors | n/a | International Mail Shipments | Undeclared fluoxetine | Public Notification | Drugs |
|
| 02/25/2015 | Lean Body Extreme | Various Distributors | n/a | International Mail Shipments | Undeclared sibutramine, desmethyl sibutramine, phenolphthalein, and sildenafil | Public Notification | Drugs |
|
| 02/09/2015 | BtRim Max | Detox Transforms Health and Nutrition | Garner, NC | n/a | Undeclared phenolphthalein | Recall | Drugs |
|
| 02/09/2015 | AMPD Gold Bee Pollen | Detox Transforms Health and Nutrition | Garner, NC | n/a | Undeclared sildenafil | Recall | Drugs |
|
| 02/09/2015 | iNDiGO | Detox Transforms Health and Nutrition | Garner, NC | n/a | Undeclared phenolphthalein | Recall | Drugs |
|
| 02/09/2015 | EDGE Amplified Weight Release | Detox Transforms Health and Nutrition | Garner, NC | n/a | Undeclared phenolphthalein and fluoxetine | Recall | Drugs |
|
| 02/09/2015 | iNSANE Bee Pollen | Detox Transforms Health and Nutrition | Garner, NC | n/a | Undeclared phenolphthalein and fluoxetine | Recall | Drugs |
|
| 02/03/2015 | Yanhee Slim | Various Distributors | n/a | n/a | Undeclared lorcaserin | Public Notification | Drugs |
|
| 01/21/2015 | Happy Passengers | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/23/2014 | Zhansheng Weige Chaoyue Xilishi | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/23/2014 | Triple PowerZen | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/23/2014 | Samurai-X | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 12/23/2014 | Slim-K | Bethel Nutritional Consulting, Inc. | New York, NY | bethel30.com | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs | |
| 12/19/2014 | B-Lipo | Bethel Nutritional Consulting, Inc. | New York, NY | bethel30.com | Undeclared lorcaserin | Recall | Drugs |
|
| 11/25/2014 | Slim Vie | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 11/25/2014 | Bee Thin | Various Distributors | n/a | beethinzxt.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 11/24/2014 | Super Extreme Accelerator | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 11/24/2014 | Bee Slim | Various Distributors | n/a | International Mail Shipments | Undeclared | Public Notification | Drugs |
|
| 11/24/2014 | Black Storm | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 11/20/2014 | Feng Shi Ling by Hong Kong Chi Chun Tang Herbal Factory | Various Distributors | n/a | n/a | Undeclared diclofenac and indomethacin | Public Notification | Drugs |
|
| 11/19/2014 | Forever Beautiful Bee Pollen | REFA Enterprises, LLC | n/a | n/a | Undeclared sibutramine and/or phenolphthalein | Recall | Drugs |
|
| 11/19/2014 | Forever Beautiful Infinity | REFA Enterprises, LLC | n/a | n/a | Undeclared sibutramine and/or phenolphthalein | Recall | Drugs |
|
| 11/14/2014 | Mayhem | Chaotic-Labz | Atkins, AR | n/a | Undeclared dexamethasone | Recall | Drugs |
|
| 11/04/2014 | V26 Slimming Coffee | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 10/30/2014 | Ginseng Kianpi Pil | Kweilin Drug Manufactory | n/a | ginsengkianpipil.com | Undeclared dexamethasone | Public Notification | Drugs |
|
| 10/10/2014 | Sit and Slim II | Various Distributors | n/a | n/a | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 09/26/2014 | Mojo Risen | Nova Products, Inc. | 5 Mount Pleasant Road, Aston, PA 19014 | n/a | Undeclared sildenafil | Warning Letter | Drugs |
|
| 09/26/2014 | XZone 1200 | Nova Products, Inc. | 5 Mount Pleasant Road, Aston, PA 19014 | n/a | Undeclared sildenafil and tadalafil | Warning Letter | Drugs |
|
| 09/26/2014 | XZone Gold | Nova Products, Inc. | 5 Mount Pleasant Road, Aston, PA 19014 | n/a | Undeclared sildenafil and tadalafil | Warning Letter | Drugs |
|
| 09/26/2014 | XZen Platinum | Nova Products, Inc. | 5 Mount Pleasant Road, Aston, PA 19014 | n/a | Undeclared sildenafil and tadalafil | Warning Letter | Drugs |
|
| 09/26/2014 | Black Ant | Nova Products, Inc. | 5 Mount Pleasant Road, Aston, PA 19014 | n/a | Undeclared sildenafil | Warning Letter | Drugs |
|
| 09/26/2014 | African Black Ant | Nova Products, Inc. | 5 Mount Pleasant Road, Aston, PA 19014 | n/a | Undeclared sildenafil | Warning Letter | Drugs |
|
| 09/12/2014 | LX1 | Various Distributors | n/a | drskinsecret.com | Undeclared DMAA | Public Notification | Foods |
|
| 09/12/2014 | Best Line Suplemento Alimenticio Capsules | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 08/11/2014 | Arize | Various Distributors | n/a | calcompnutrition.com | Undeclared sulfoaildenafil | Public Notification | Drugs |
|
| 08/11/2014 | Herbal Vigor Quick Fix | Various Distributors | n/a | calcompnutrition.com | Undeclared tadalafil | Public Notification | Drugs |
|
| 07/22/2014 | O.M.G | Various Distributors | n/a | sears.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 07/08/2014 | Mix Fruit Slimming | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/08/2014 | Lipo 8 Burn Slim | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/08/2014 | 24 Ince | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/08/2014 | Sliming Diet By Pretty White | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/08/2014 | Lingzhi Cleansed Slim Tea | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 07/08/2014 | Trim-Fast Slimming Softgel | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 06/17/2014 | Miraculous Evil Root | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/17/2014 | Toxin Discharged Tea | Various Distributors | n/a | n/a | Undeclared fluoxetine | Public Notification | Drugs |
|
| 06/17/2014 | Sport Burner | Various Distributors | n/a | n/a | Undeclared fluoxetine | Public Notification | Drugs |
|
| 06/17/2014 | Gold Vigra | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/17/2014 | Sliming Diet | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 06/10/2014 | La Jiao Shou Shen | Various Distributors | n/a | n/a | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 06/05/2014 | B-Perfect | Various Distributors | n/a | icanb-perfect.com | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 06/02/2014 | Eyeful | Various Distributors | n/a | n/a | Undeclared hydroxythiohomosildenafil | Public Notification | Drugs |
|
| 06/02/2014 | 3 Hard Knights | Various Distributors | n/a | n/a | Undeclared sildenafil and thiosildenafi | Public Notification | Drugs |
|
| 06/02/2014 | Liu Bian Li | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 06/02/2014 | Full Throttle On Demand | Various Distributors | n/a | overstock.com | Undeclared propoxyphenyl sildenafil | Public Notification | Drugs |
|
| 06/02/2014 | Dick's Hard Up | Various Distributors | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 06/02/2014 | GoldReallas | Various Distributors | n/a | n/a | Undeclared sildenafil and thiosildenafi | Public Notification | Drugs |
|
| 05/16/2014 | MV 5 Days | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 05/16/2014 | Asset Bold | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 05/12/2014 | Asset Bee Pollen | Various Distributors | n/a | assetcapsules4u.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 05/05/2014 | Natural Body Solution | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 05/05/2014 | Slim Trim U | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 04/21/2014 | Super Arthgold | Nano Well-being Health Inc. | La Mirada, CA | n/a | Undeclared chlorzoxazone, diclofenac and indomethacin | Recall | Drugs |
|
| 04/16/2014 | S.W.A.G | Various Distributors | n/a | sexwithagrudge.com | Undeclared sildenafil | Public Notification | Drugs |
|
| 04/10/2014 | Lite Fit USA | Various Distributors | n/a | herbsultimate.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 04/10/2014 | Infinity | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 04/09/2014 | Thinogenics | Nature’s Universe | n/a | shopnaturesuniverse.com; easy2loseweight.com | Undeclared sibutramine | Recall | Drugs |
|
| 04/02/2014 | New You | Various Distributors | n/a | n/a | Undeclared sibutramine and phenolphthalein | Public Notification | Drugs |
|
| 03/26/2014 | Bella Vi Insane Bee Pollen Capsules | Pure Edge Nutrition, LLC | Toms River, NJ | n/a | Undeclared sibutramine and/or phenophthalein | Recall | Drugs |
|
| 03/26/2014 | Bella Vi BTrim Ultimate Boost | Pure Edge Nutrition, LLC | Toms River, NJ | n/a | Undeclared sibutramine and/or phenophthalein | Recall | Drugs |
|
| 03/26/2014 | Bella Vi BTrim Max | Pure Edge Nutrition, LLC | Toms River, NJ | n/a | Undeclared sibutramine and/or phenophthalein | Recall | Drugs |
|
| 03/26/2014 | Bella Vi Extreme Accelerator | Pure Edge Nutrition, LLC | Toms River, NJ | n/a | Undeclared sibutramine and/or phenophthalein | Recall | Drugs |
|
| 03/26/2014 | Bella Vi Insane Amp’d | Pure Edge Nutrition, LLC | Toms River, NJ | n/a | Undeclared sibutramine and/or phenophthalein | Recall | Drugs |
|
| 03/26/2014 | Bella Vi Amp’d Up | Pure Edge Nutrition, LLC | Toms River, NJ | n/a | Undeclared sibutramine and/or phenophthalein | Recall | Drugs |
|
| 03/26/2014 | Super Fat Burner | New Life Nutritional Center | n/a | n/a | Undeclared sibutramine and/or phenophthalein | Recall | Drugs |
|
| 03/26/2014 | Maxi Gold | New Life Nutritional Center | n/a | n/a | Undeclared sibutramine and/or phenophthalein | Recall | Drugs |
|
| 03/26/2014 | Esmeralda | New Life Nutritional Center | n/a | n/a | Undeclared sibutramine and/or phenophthalein | Recall | Drugs |
|
| 03/19/2014 | Vitaccino Coffee | Various Distributors | n/a | n/a | Undeclared sibutramine | Public Notification | Drugs |
|
| 03/07/2014 | Weekend Warrior | Various Distributors | n/a | onlinecoralcalcium.com | Undeclared thiosildenafil | Public Notification | Drugs |
|
| 02/13/2014 | Arth-Q, “알쓰큐” or “알쓰Q" | Various Distributors | n/a | kaymall.com | Undeclared ibuprofen | Public Notification | Drugs |
|
| 02/04/2014 | Magic Slim | MyNicNaxs, Inc. | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sibutramine, N-desmethylsibutramine and benzylsibutramine | Recall | Drugs | |
| 02/04/2014 | Fruta Bio | MyNicNaxs, Inc. | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sibutramine and phenolphthalein | Recall | Drugs | |
| 02/04/2014 | SlimEasy | MyNicNaxs, Inc. | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sibutramine and N-desmethylsibutramine | Recall | Drugs | |
| 02/04/2014 | Super Fat Burning Bomb | MyNicNaxs, Inc. | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared N-desthylsibutraminea nd phenolphthalein | Recall | Drugs | |
| 02/04/2014 | Slim Xtreme | MyNicNaxs, Inc. | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sibutramine, N-desmethylsibutramine and benzylsibutramine | Recall | Drugs | |
| 02/04/2014 | Meizi Evolution | MyNicNaxs, Inc. | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sibutramine, N-desmethylsibutramine and benzylsibutramine | Recall | Drugs | |
| 02/04/2014 | Meizitang Strong Version Botanical Slimming | MyNicNaxs, Inc. | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared sibutramine, N-desmethylsibutramine and benzylsibutramine | Recall | Drugs | |
| 02/04/2014 | Jianfeijindan Activity Girl | MyNicNaxs, Inc. | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared N-di-desmethylsibutramine | Recall | Drugs | |
| 02/04/2014 | Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill | MyNicNaxs, Inc. | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared phenolphthalein | Recall | Drugs | |
| 02/04/2014 | Reduce Weight Fruta Planta | MyNicNaxs, Inc. | 1012 Alpine Dr, Deltona, FL 32725 | mynicnaxs.com; ruglamourous.com | Undeclared phenolphthalein | Recall | Drugs | |
| 01/28/2014 | Bali Mojo | Various Distributors | n/a | n/a | Undeclared tadalafil | Public Notification | Drugs |
|
| 01/28/2014 | Hot Detox | Various Distributors | n/a | hotdetoxllc.com | Undeclared sibutramine | Public Notification | Drugs |
|
| 01/28/2014 | Citrus Fit Gold | Citrus Fit Weight Loss and Detox Products, LLC | n/a | citrusfit.com | Undeclared sibutramine | Public Notification | Drugs | |
| 01/28/2014 | JINQIANGBUDOR Red Dragon | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 01/28/2014 | Tiger King | Various Distributors | n/a | n/a | Undeclared sildenafil | Public Notification | Drugs |
|
| 01/28/2014 | SexRx | Various Distributors | n/a |
