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  1. Health Fraud Scams

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
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  
07/20/2021 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  
07/22/2021 Miss Slim HIS Palisades Park, NJ missslimusa.com Undeclared sibutramine Recall 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

Recall

Warning Letter

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 3000 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 Women 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, creams, gels, sprays, and 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 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  
12/18/2020 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  
12/17/2020 Triple SupremeZen Plus 3500 Various Distributors; Recall by Yolo Studio/Hyobin LLC n/a amazon.com Undeclared tadalafil Public Notification Drugs

News Release

Untitled Letter

12/17/2020 Shogun-X Black Various Distributors; Recall by Ummzy LLC/Knabe Inc n/a amazon.com Undeclared tadalafil Public Notification Drugs

News Release

Recall

Untitled Letter

12/17/2020 Triple SupremeZen Extreme 3500 Various Distributors; including seller Otwo n/a amazon.com Undeclared sildenafil and tadalafil Public Notification Drugs

News Release

Untitled Letter

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

News Release

Recall

Untitled Letter

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

News Release

Recall (Antoto-K); Recall (Ummzy LLC/Knabe Inc)

Untitled Letter

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

News Release

Recall

Untitled Letter

12/17/2020 Thumbs Up 7 Black 25K Various Distributors; Recall by Nuri Trading LLC n/a amazon.com Undeclared tadalafil Public Notification Drugs

News Release

Recall

Untitled Letter

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

News Release

Untitled Letter

12/17/2020 Red Spartan 3000 Various Distributors; including seller Amazon.com n/a amazon.com Undeclared sildenafil and tadalafil Public Notification Drugs

News Release

Untitled Letter

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

News Release

Recall

Untitled Letter

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

News Release

Recall

Untitled Letter

12/17/2020 PremierZen Extreme 3000 Various Distributors; Recalls by QMART and Yolo Studio n/a amazon.com Undeclared tadalafil Public Notification Drugs

News Release

Recall (QMART); Recall (Yolo Studio)

Untitled Letter

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

News Release

Recall

Untitled Letter

12/17/2020 Original White Dragon Various Distributors; including seller A&D Health n/a amazon.com Undeclared sildenafil and tadalafil Public Notification Drugs

News Release

Untitled Letter

12/17/2020 Krazy Night Various Distributors; Recall by Ummzy LLC/Knabe Inc n/a amazon.com Undeclared tadalafil Public Notification Drugs

News Release

Recall

Untitled Letter

12/17/2020 Kopi Jantan Tradisional Natural Herbs Coffee Various Distributors; including seller smile_elephant n/a amazon.com Undeclared sildenafil Public Notification Drugs

News Release

Untitled Letter

12/17/2020 Imperial Platinum 2000 Various Distributors; Recall by QMART n/a amazon.com Undeclared tadalafil Public Notification Drugs

News Release

Recall

Untitled Letter

12/17/2020 Imperial Gold 2000 Various Distributors; Recall by QMART n/a amazon.com Undeclared sildenafil and tadalafil Public Notification Drugs

News Release

Recall

Untitled Letter

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

News Release

Recall

Untitled Letter

12/17/2020 Hot Rod Various Distributors; including BZ USA LLC/BZ USA LLC n/a amazon.com Undeclared tadalafil Public Notification Drugs

News Release

Untitled Letter

12/17/2020 Ginseng Power 5000 Various Distributors; Recall by 
NS NY Distributor Inc
n/a amazon.com Undeclared tadalafil Public Notification Drugs

News Release

Recall

Untitled Letter

12/17/2020 Burro en Primavera 60000 Various Distributors; Recall by QMART n/a amazon.com Undeclared tadalafil Public Notification Drugs

News Release

Recall

Untitled Letter

12/17/2020 69MODE Blue 69 Various Distributors; Recall by Nuri Trading LLC n/a amazon.com Undeclared tadalafil Public Notification Drugs

News Release

Recall

Untitled Letter

12/17/2020 3 KO Gold XT Various Distributors; including seller Vitality Mate n/a amazon.com Undeclared vardenafil Public Notification Drugs

News Release

Untitled Letter

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

News Release

Recall

Untitled Letter

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

News Release

Recall

Untitled Letter

12/17/2020 Burn 7 Various Distributors; including seller befitaholic  n/a ebay.com Undeclared phenolphthalein Public Notification Drugs News Release
12/17/2020 Premier maxxzen Platinum 12000 Various Distributors; including seller Miracle8989 n/a ebay.com Undeclared sildenafil and tadalafil Public Notification Drugs

News Release

Recall

12/17/2020 Poseidon Platinum 10000 Various Distributors; including seller co.america n/a ebay.com Undeclared vardenafil Public Notification Drugs News Release
12/17/2020 Poseidon Platinum 3500 Various Distributors; including seller Yamtun7 n/a ebay.com Undeclared sildenafil and tadalafil Public Notification Drugs

News Release

Recall

12/17/2020 Mero Macho Various Distributors; including seller setec24  n/a ebay.com Undeclared tadalafil Public Notification Drugs News Release
12/17/2020 Gold Lion Various Distributors; including seller unityhealth  n/a ebay.com Undeclared sildenafil Public Notification Drugs News Release
12/17/2020 White Panther Various Distributors; including seller qualmart1-9 n/a ebay.com Undeclared sildenafil and tadalafil Public Notification Drugs News Release
12/17/2020 Triple Wicked Platinum Various Distributors; including seller pricemasters_usa n/a ebay.com Undeclared sildenafil and tadalafil Public Notification Drugs News Release
12/17/2020 The Super Panther 77k Various Distributors; including seller qualmart1-9  n/a ebay.com Undeclared sildenafil and tadalafil Public Notification Drugs News Release
12/17/2020 Royal Honey Various Distributors; including seller ahmedjamilmuslim  n/a ebay.com Undeclared tadalafil Public Notification Drugs News Release
12/17/2020 PremierZen Gold 7000 Various Distributors; Recall by Miracle8989 n/a ebay.com Undeclared sildenafil and tadalafil Public Notification Drugs

News Release

Recall

12/17/2020 PremierZen Platinum 8000 Various Distributors; Recall by Miracle8989 n/a ebay.com Undeclared sildenafil and tadalafil Public Notification Drugs

News Release

Recall

12/17/2020 Blue Panther Extreme 75k Various Distributors; including seller qualmart1-9  n/a ebay.com Undeclared sildenafil and tadalafil Public Notification Drugs News Release
12/17/2020 Black Stallion 9000 Various Distributors; including seller qualmart1-9  n/a ebay.com Undeclared tadalafil Public Notification Drugs News Release
12/17/2020 Lishou Slimming Coffee Various Distributors; including seller annday14 n/a ebay.com Undeclared sibutramine and desmethylsibutramine Public Notification Drugs News Release
12/17/2020 Li Da Daidaihua Plus Various Distributors; including seller micki_jay n/a ebay.com Undeclared phenolphthalein Public Notification Drugs News Release
12/17/2020 Imperla Elita Vitaccino Various Distributors; Recall by Dash Xclusive n/a ebay.com Undeclared sibutramine and fluoxetine Public Notification Drugs

News Release

Recall

12/17/2020 Fruta Planta Various Distributors; including seller aialoj0  n/a ebay.com Undeclared sibutramine Public Notification Drugs News Release
12/17/2020 Fruta Bio Various Distributors; including seller frutabio  n/a ebay.com Undeclared sibutramine and phenolphthalein Public Notification Drugs News Release
12/17/2020 Super Slim Various Distributors; including seller emmcli0  n/a ebay.com Undeclared sibutramine and desmethylsibutramine Public Notification Drugs News Release
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  
05/11/2020 “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  
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 Sheaya Lender Various Distributors n/a International Mail Shipments Undeclared sibutramine and fluoxetine 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 Warning Letter
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 Warning Letter
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 Warning Letter
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 Warning Letter
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 Warning Letter
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 Warning Letter
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 Warning Letter
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 Warning Letter
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 Warning Letter
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 Warning Letter
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  
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  
8/10/2018 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 Consent Decree
07/11/2018 Slimming Plus Advanced Weight Loss MyNicNaxs, LLC 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared sildenafil Recall Drugs Consent Decree
07/11/2018 African Viagra MyNicNaxs, LLC 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared sildenafil Recall Drugs Consent Decree
07/11/2018 GINSENG  MyNicNaxs, LLC 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared sildenafil Recall Drugs Consent Decree
07/11/2018 African Superman MyNicNaxs, LLC 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared sildenafil Recall Drugs Consent Decree
07/11/2018 Old Chinese MyNicNaxs, LLC 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared sildenafil Recall Drugs Consent Decree
07/11/2018 Lean Extreme Max MyNicNaxs, LLC 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared sibutramine Recall Drugs Consent Decree
07/11/2018 X-treme Beauty Slim MyNicNaxs, LLC 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared sibutramine Recall Drugs Consent Decree
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 Consent Decree
07/11/2018 Slim Evolution MyNicNaxs, LLC 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared diclofenac Recall Drugs Consent Decree
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 Consent Decree
07/11/2018 Fruta Planta MyNicNaxs, LLC 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared sibutramine and phenolphthalein Recall Drugs Consent Decree
07/11/2018 Botanical Slimming MyNicNaxs, LLC 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared API Recall Drugs Consent Decree
07/11/2018 Slim Body MyNicNaxs, LLC 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared API Recall Drugs Consent Decree
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  
09/06/2018 Purblack Adaptive Energy LLC 109 E 17th St. Ste 4, Cheyenne, WY 82001 purblack.com New Drug/Misbranded Warning Letter Foods Close-out Letter
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 Close-out Letter
05/18/2018 Solaricare Pharmacy Direct, PDU 8 The Green, Suite 5871, Dover, DE 19901 solaricare.com New Drug/Labeling/Misbranded Warning Letter Foods Close-out Letter
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 Letters Foods; Drugs  
05/14/2018 Bones Olivia’s Healing Herbs 1102 Edgefield St.
Killeen, TX 75649-2112
oliviashealingherbs.com New Drugs Online Advisory Letters Foods; Drugs  
05/14/2018 Viral-X Olivia’s Healing Herbs 1102 Edgefield St.
Killeen, TX 75649-2112
oliviashealingherbs.com New Drugs Online Advisory Letters Foods; Drugs  
05/14/2018 Candida Olivia’s Healing Herbs 1102 Edgefield St.
Killeen, TX 75649-2112
oliviashealingherbs.com New Drugs Online Advisory Letters Foods; Drugs  
05/14/2018 Iron Infusion Olivia’s Healing Herbs 1102 Edgefield St.
Killeen, TX 75649-2112
oliviashealingherbs.com New Drugs Online Advisory Letters Foods; Drugs  
05/14/2018 Mental Focus Olivia’s Healing Herbs 1102 Edgefield St.
Killeen, TX 75649-2112
oliviashealingherbs.com New Drugs Online Advisory Letters 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 Letters 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 Letters Foods; Drugs  
05/14/2018 Niagra Olivia’s Healing Herbs 1102 Edgefield St.
Killeen, TX 75649-2112
oliviashealingherbs.com New Drugs Online Advisory Letters 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 Letters 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 Letters 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 Letters 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 Warning Letter
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 Expanded Recall
09/20/2017 Papa Zen 3300 Gadget Island, Inc. dba Gear Isle n/a gearisle.com Undeclared sildenafil and tadalafil Recall Drugs Expanded Recall
09/20/2017 Fifty Shades 6000 Gadget Island, Inc. dba Gear Isle n/a gearisle.com Undeclared sildenafil and tadalafil Recall Drugs Expanded Recall
09/20/2017 Grande X 5800 Gadget Island, Inc. dba Gear Isle n/a gearisle.com Undeclared sildenafil and tadalafil Recall Drugs Expanded Recall
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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 Warning Letter
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 Warning Letter
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 Recall
07/02/2015 Zero Xtreme  Fat Burners Zone n/a zeroxtremeusa.com Undeclared sibutramine and desmethylsibutramine Public Notification Drugs Recall
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  
06/03/2015 Smart Lipo SmartLipo365 and Centro Naturista 2915 East Division Street, Suite 523, Arlington, TX76011 smartlipo365.com Undeclared sibutramine, desmethylsibutramine, and phenolphthalein Recall Drugs

Expanded Recall

Warning Letter

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  
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 Recall
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 1200 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  
09/26/2014 XZen Gold Nova Products, Inc. 5 Mount Pleasant Road, Aston, PA 19014 n/a Undeclared sildenafil and tadalafil 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  
09/12/2014 Mezo Various Distributors n/a n/a Undeclared benzylsibutramine 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  
06/05/2014 Zhen Gong Fu Various Distributors n/a n/a Undeclared sildenafil 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

Warning Letter

Additional Recall

Consent Decree

02/04/2014 Fruta Bio MyNicNaxs, Inc. 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared sibutramine and phenolphthalein Recall Drugs

Warning Letter

Additional Recall

Consent Decree

02/04/2014 SlimEasy MyNicNaxs, Inc. 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared sibutramine and N-desmethylsibutramine Recall Drugs

Warning Letter

Additional Recall

Consent Decree

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

Warning Letter

Additional Recall

Consent Decree

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

Warning Letter

Additional Recall

Consent Decree

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

Warning Letter

Additional Recall

Consent Decree

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

Warning Letter

Additional Recall

Consent Decree

02/04/2014 Jianfeijindan Activity Girl MyNicNaxs, Inc. 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared N-di-desmethylsibutramine Recall Drugs

Warning Letter

Additional Recall

Consent Decree

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

Warning Letter

Additional Recall

Consent Decree

02/04/2014 Reduce Weight Fruta Planta MyNicNaxs, Inc. 1012 Alpine Dr, Deltona, FL 32725 mynicnaxs.com; ruglamourous.com Undeclared phenolphthalein Recall Drugs

Warning Letter

Additional Recall

Consent Decree

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 Warning Letter
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 alternative-health-supplements.com Undeclared sildenafil and tadalafil Public Notification Drugs  
01/28/2014 Tonic Life BP Various Distributors n/a tonic-life-products.com Undeclared phenolphthalein Public Notification Drugs  
01/21/2014 Dream Body Slimming Capsule Slim Beauty USA 503 E. 23rd St.
Kearney, NE 68847
slimbeautyusa.com Undeclared sibutramine Public Notification Drugs Warning Letter
01/21/2014 Magic Slim Slim Beauty USA 503 E. 23rd St.
Kearney, NE 68847
slimbeautyusa.com Undeclared sibutramine Public Notification Drugs Warning Letter
01/15/2014 Pro ArthMax Various Distributors n/a n/a Undeclared diclofenac, ibuprofen, naproxen, indomethacin, nefopam, and chlorzoxazone Public Notification Drugs  
01/09/2014 Magic for Men Midwest Wholesale Nixa, MO n/a Undeclared sildenafil and/or tadalafil Recall Drugs  
01/09/2014 Boost Ultra Midwest Wholesale Nixa, MO n/a Undeclared sildenafil and/or tadalafil Recall Drugs  
01/09/2014 XZone Gold Midwest Wholesale Nixa, MO n/a Undeclared sildenafil and/or tadalafil Recall Drugs  
01/09/2014 Sexy Monkey Midwest Wholesale Nixa, MO n/a Undeclared sildenafil and/or tadalafil Recall Drugs  
01/09/2014 Triple MiracleZen Platinum Midwest Wholesale Nixa, MO n/a Undeclared sildenafil and/or tadalafil Recall Drugs  
01/09/2014 "New" Extenze Midwest Wholesale Nixa, MO n/a Undeclared sildenafil and/or tadalafil Recall Drugs  
01/09/2014 New XZen Platinum Midwest Wholesale Nixa, MO n/a Undeclared sildenafil and/or tadalafil Recall Drugs  
12/23/2013 Burn 7 Deseo Rebajar Inc. n/a deseorebajar.com Undeclared phenolphthalein Public Notification Drugs Recall
12/23/2013 Mass Destruction Blunt Force Nutrition n/a n/a Labeled to contain at least one synthetic anabolic steroid Press Release Drugs  
12/19/2013 SlimEasy Herbs Capsule Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
12/19/2013 CONTROL All Natural Sexual Enhancement Various Distributors n/a n/a Undeclared sulfoaildenafil and dimethylsildenafil Public Notification Drugs  
12/19/2013 Asset Extreme Plus Various Distributors n/a allnaturalbeelievers.com Undeclared sibutramine Public Notification Drugs  
12/19/2013 Best Whips Various Distributors n/a n/a Undeclared sildenafil Public Notification Drugs  
12/19/2013 Asset Extreme Various Distributors n/a assetcapsules4u.com Undeclared sibutramine Public Notification Drugs  
12/19/2013 7 Days Herbal Slim Various Distributors n/a suncoastspaequipment.com Undeclared sibutramine  Public Notification Drugs  
12/19/2013 Dr. Ming's Chinese Capsule Various Distributors n/a slimbeautyusa.com Undeclared sibutramine  Public Notification Drugs Warning Letter
12/19/2013 Sliming Diet Berry Plus Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
12/19/2013 Meizitang Citrus Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
11/29/2013 Hydravax IQ Formulations Sunrise, FL n/a Undeclared diuretic Recall Drugs  
11/21/2013 Alpha Male Various Distributors n/a n/a Undeclared aminotadalafil, sulfosildenafil, sulfoaildenafil, hydroxythiohomosildenafil, dimethylsildenafil, and sildenafil Public Notification Drugs  
11/21/2013 SlimExtra Herbal Capsules Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
11/21/2013 Body Beauty 5 Days Slimming Coffee Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
11/21/2013 Diet Master Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
11/21/2013 Super Slim Various Distributors n/a bonanza.com Undeclared sibutramine and phenolphthalein Public Notification Drugs  
11/20/2013 Slim Max Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
11/19/2013 P-Boost Tendex  Los Angeles, CA n/a Undeclared tadalafil  Recall Drugs  
11/19/2013 NatuRECT Tendex  Los Angeles, CA n/a Undeclared tadalafil  Recall Drugs  
11/18/2013 RezzRX Fossil Fuel Products, LLC n/a n/a Undeclared hydroxylthiohomosildenafil and aminotadalafil Recall Drugs  
11/16/2013 Rhino 5 Plus Jobbers Wholesale Paramount, CA n/a Undeclared desmethylcarbondenafil and dapoxetine Recall Drugs  
11/16/2013 Maxtremezen Jobbers Wholesale Paramount, CA n/a Undeclared desmethylcarbondenafil and dapoxetine Recall Drugs  
11/16/2013 Extenzone Various Distributors Paramount, CA n/a Undeclared desmethylcarbondenafil and dapoxetine Recall Drugs  
11/14/2013 Adipotrim XT Deseo Rebajar Inc. n/a deseorebajar.com Undeclared fluoxetine Recall Drugs  
11/08/2013 Vitalikor Fast Acting Various Distributors n/a vitalityreseasrchlabs.com; vitalikor.com; gnc.com Undeclared tadalafil and vardenafil Public Notification Drugs  
11/07/2013 Jimpness Beauty Fat Loss Capsules Various Distributors n/a jimpness.net Undeclared ramine, phenolphthalein, and sildenafil Public Notification Drugs  
11/05/2013 Goodliness Fat-Reducing Capsules Various Distributors n/a n/a Undeclared sibutramine and phenolphthalein Public Notification Drugs  
10/10/2013 Be Inspired Various Distributors n/a beinspirednaturally.com Undeclared sibutramine Public Notification Drugs  
10/10/2013 Dr. Mao Slimming Capsules Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/10/2013 Perfect Body Solutions  Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/10/2013 Bella Vi Insane Amp’d  Various Distributors n/a pureedgenutrition.com; newedgenutrition.com Undeclared sibutramine and phenolphthalein Public Notification Drugs  
10/10/2013 Bella Vi Amp’d Up Various Distributors n/a pureedgenutrition.com; newedgenutrition.com Undeclared sibutramine and phenolphthalein Public Notification Drugs  
10/07/2013 Lidiy B@B Trade, Inc FL lidiy.com Undeclared sibutramine Recall Drugs  
10/07/2013 Slim Fortune B@B Trade, Inc FL slimfortune.com Undeclared sibutramine Recall Drugs  
10/07/2013 Slim Expert B@B Trade, Inc FL slimexpert.com Undeclared sibutramine Recall Drugs  
09/24/2013 Virilis Pro Haute Health, LLC Williamstown, NJ virilispro.com Undeclared sildenafil Recall Drugs  
09/24/2013 PHUK  Haute Health, LLC Williamstown, NJ virilispro.com Undeclared sildenafil Recall Drugs  
09/24/2013 Prolifta  Haute Health, LLC Williamstown, NJ virilispro.com Undeclared sildenafil Recall Drugs  
09/24/2013 XZen Xpress Various Distributors n/a n/a Undeclared sildenafil and tadalafil Public Notification Drugs  
09/24/2013 XZen 1200 Various Distributors n/a n/a Undeclared tadalafil Public Notification Drugs  
09/24/2013 XZone Premium Various Distributors n/a n/a Undeclared sildenafil, tadalafil, and dapoxetine Public Notification Drugs  
09/24/2013 Xzen Gold Various Distributors n/a n/a Undeclared sildenafil and tadalafil Public Notification Drugs  
09/24/2013 Wood-E Various Distributors n/a netnutri.com Undeclared sildenafil Public Notification Drugs  
09/24/2013 Instant Slim, 收腹提臀果香型减肥胶囊, Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang, or Сокращать живот и повышать 3ад Various Distributors n/a instantslim.org Undeclared sibutramine Public Notification Drugs  
08/27/2013 Pro Power Max Hardmenstore.com Fort Lauderdale, FL n/a Undeclared sildenafil Recall Drugs  
08/27/2013 Evil Root Hardmenstore.com Fort Lauderdale, FL n/a Undeclared sildenafil Recall Drugs  
08/27/2013 72HP Hardmenstore.com Fort Lauderdale, FL n/a Undeclared sildenafil Recall Drugs  
08/22/2013 Ortiga Various Distributors n/a ebay.com Undeclared diclofenac Public Notification Drugs  
08/07/2013 Tranquility Health and Beyond, LLC Boca Raton, FL n/a Undeclared doxepin and chlorpormazine  Recall Drugs  
08/05/2013 Quick Thin Bethel Nutritional Consulting, Inc. New York, NY bethel30.com Undeclared sibutramine and phenolphthalein Recall Drugs  
08/05/2013 Bethel Advance Bethel Nutritional Consulting, Inc. New York, NY bethel30.com Undeclared sibutramine and phenolphthalein Recall Drugs  
07/19/2013 Esbelin siloutte te Herbal Give Care LLC Grand Prairie, TX n/a Undeclared Ssbutramine, N-desmethylsibutramine, and N-di-desmethylsibutramine Recall Drugs  
07/19/2013 Esbelin siloutte Herbal Blend with L-Carnitine Herbal Give Care LLC Grand Prairie, TX n/a Undeclared Ssbutramine, N-desmethylsibutramine, and N-di-desmethylsibutramine Recall Drugs  
07/18/2013 Volcano Male Enhancement Liquid Volcano Company Long Beach, CA n/a Undeclared desmethyl carbodenafil, dimethylsildenafil, and dapoxetine Recall Drugs  
07/18/2013 Volcano Male Enhancement Capsules Volcano Company Long Beach, CA n/a Undeclared desmethyl carbodenafil and dapoxetine Recall Drugs  
06/28/2013 Clalis Various Distributors n/a hardmenstore.com Undeclared sildenafil Public Notification Drugs  
06/28/2013 MaxTreme Zen Various Distributors n/a n/a Undeclared sildenafil and tadalafil Public Notification Drugs  
06/28/2013 Exten 1300 Various Distributors n/a n/a Undeclared sildenafil and tadalafil Public Notification Drugs  
06/28/2013 MVP Mega Various Distributors n/a n/a Undeclared tadalafil Public Notification Drugs  
06/27/2013 Meizi Evolution Various Distributors n/a ebay.com Undeclared sibutramine Public Notification Drugs  
06/27/2013 Strawberry Balance Various Distributors n/a n/a Undeclared sibutramine and phenolphthalein Public Notification Drugs  
06/27/2013 Silver Sword Various Distributors n/a hardmenstore.com Undeclared sildenafil Public Notification Drugs  
06/18/2013 Fat Zero Various Distributors n/a n/a Undeclared sibutramine and phenolphthalein Public Notification Drugs  
06/18/2013 Fruit & Plant Slimming Various Distributors n/a n/a Undeclared sibutramine and phenolphthalein Public Notification Drugs  
06/18/2013 Royal Dragon Herbal Tonic Balls Various Distributors n/a n/a Undeclared vardenafil Public Notification Drugs  
06/18/2013 Extreme Body Slim Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
06/18/2013 Paiyouji Plus Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
06/10/2013 Get It Up Various Distributors n/a ebay.com Undeclared sildenafil Public Notification Drugs  
06/10/2013 Super Cheetah Various Distributors n/a bonanza.com Undeclared sildenafil Public Notification Drugs  
06/10/2013 XIYOUJI QINGZHI CAPSULE Various Distributors n/a jadera.net Undeclared sibutramine Public Notification Drugs  
06/10/2013 X Zen Platinum Various Distributors n/a ebay.com Undeclared sildenafil and tadalafil Public Notification Drugs  
06/10/2013 Nights to Remember Various Distributors n/a n/a Undeclared sildenafil Public Notification Drugs  
06/10/2013 Cave Diver Various Distributors n/a bonanza.com Undeclared sildenafil Public Notification Drugs  
06/10/2013 Reload Various Distributors n/a reloadpill.com Undeclared sildenafil Public Notification Drugs  
06/10/2013 Bethel 30 Bethel Nutritional Consulting, Inc. New York, NY bethel30.com Undeclared sibutramine Public Notification Drugs

Recall 

Expanded Recall

06/10/2013 Mojo Risen Various Distributors n/a ebay.com Undeclared noracetildenafil Public Notification Drugs  
05/07/2013 SexVoltz  BeaMonstar Products Queen Creek, AZ n/a Undeclared tadalafil Recall Drugs Expanded Recall
05/07/2013 Velextra  BeaMonstar Products Queen Creek, AZ n/a Undeclared tadalafil Recall Drugs  
05/07/2013 Amerect  BeaMonstar Products Queen Creek, AZ n/a Undeclared tadalafil Recall Drugs  
05/07/2013 Lightning Rod Chang Kwung n/a n/a Undeclared analogue of sildenafil Recall Drugs  
05/07/2013 Bullet Proof Various Distributors n/a n/a Undeclared tadalafil Public Notification Drugs  
05/01/2013 Vicerex American Lifestyle 640 Kreag Road, Pittsford, NY 14534 n/a Undeclared tadalafil  Recall Drugs  
05/01/2013 Black Ant American Lifestyle 640 Kreag Road, Pittsford, NY 14534 n/a Undeclared sildenafil Recall Drugs  
04/25/2013 Zoom-Zooma-Zoom Amrutam Life Care Pvt. Ltd. India amrutamlifecare.com Undeclared sildenafil Public Notification Drugs Warning Letter
04/25/2013 Sex Plus Various Distributors n/a n/a Undeclared sildenafil, tadalafil, sulfosildenafil and dimethylacetildenafil Public Notification Drugs  
04/11/2013 Affirm XL Affirm XL, Inc n/a n/a Undeclared analogue of sildenafil Recall Drugs  
04/04/2013 MAXILOSS Weight Advanced Blue Various Distributors n/a extremevitaminworld.com; dreamlifeweightloss.com Undeclared sibutramine Public Notification Drugs  
04/03/2013 Love Rider Various Distributors n/a n/a Undeclared tadalafil Public Notification Drugs  
04/03/2013 Ninja Mojo Various Distributors n/a n/a Undeclared tadalafil Public Notification Drugs  
03/21/2013 Stiff Days Various Distributors n/a stiffdays.com Undeclared sildenafil Public Notification Drugs  
03/21/2013 Libido Sexual Enhancer Various Distributors n/a vegasredpleasure.com Undeclared hydroxythiohomosildenafil, hydroxyhomosildenafil, sildenafil, and tadalafil Public Notification Drugs  
03/12/2013 Night Bullet Green Planet, Inc. Riverside, CA n/a Undeclared sulfohydroxyhomosildenafil and aminotadalafil Recall Drugs  
01/24/2013 Super Power D&S Herbals, LLC, d/b/a Freedom Trading Woodbridge, NJ n/a Undeclared sildenafil Recall Drugs  
01/08/2013 MAXILOSS Weight Advanced Various Distributors n/a dreamlifeweightloss.com Undeclared sibutramine Public Notification Drugs  
12/19/2012 WOW Riger Naturals S.A. n/a gonepainfree.com; browerent.com; refumofanusa.com Undeclared dexamethasone, diclofenac sodium and methocrabamol Public Notification Drugs Consumer Update
12/19/2012 Slimdia Revolution P&J Trading n/a pinkfatty.com Undeclared sibutramine Recall Drugs Public Notification
12/17/2012 Libigrow XXX Performance Plus Marketing, Inc. CA n/a Undeclared sulfoaildenafil and thioaidenafil Recall Drugs  
12/17/2012 Casanova Performance Plus Marketing, Inc CA n/a Undeclared sulfoaildenafil and thioaidenafil Recall Drugs  
12/17/2012 Mojo Nights Performance Plus Marketing, Inc CA n/a Undeclared sulfoaildenafil and thioaidenafil Recall Drugs  
12/17/2012 Mojo Nights Supreme Performance Plus Marketing, Inc CA n/a Undeclared sulfoaildenafil and thioaidenafil Recall Drugs  
12/17/2012 Blue Diamond Platinum Performance Plus Marketing, Inc CA n/a Undeclared sulfoaildenafil and thioaidenafil Recall Drugs  
12/17/2012 Libigrow Performance Plus Marketing, Inc CA n/a Undeclared sulfoaildenafil and thioaidenafil Recall Drugs  
12/17/2012 Blue Diamond Performance Plus Marketing, Inc CA n/a Undeclared sulfoaildenafil and thioaidenafil Recall Drugs  
11/08/2012 Best Share Green Coffee: Brazilian Slimming Coffee Various Distributors n/a houseofmonet.com Undeclared sibutramine Public Notification Drugs  
11/08/2012 Beautiful Slim Body Various Distributors n/a houseofmonet.com Undeclared sibutramine Public Notification Drugs  
11/08/2012 Japan Hokkaido Slimming Weight Loss Pills Various Distributors n/a ebay.com Undeclared sibutramine Public Notification Drugs  
10/24/2012 Classic Zi Xiu Tang Bee Pollen Zi Xiu Tang Success, LLC Trexlertown, PA n/a Undeclared sibutramine Recall Drugs  
10/24/2012 Ultimate Formula Capsules Zi Xiu Tang Success, LLC Trexlertown, PA n/a Undeclared sibutramine Recall Drugs  
10/04/2012 Tianji True Slim Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
09/12/2012 ACTRA-Sx 500 Body Basics Inc. n/a n/a Undeclared sildenafil Recall Drugs  
08/23/2012 Mojo Nights Evol Nutrition Associates, Inc./Red Dawn Kennesaw, GA n/a Undeclared tadalafil and sildenafil Recall Drugs  
08/21/2012 Reumofan Plus Premium Riger Naturals S.A. n/a n/a Undeclared diclofenac sodium and methocarbamol News Release Drugs

Consumer Update

Recalls

08/03/2012 Best Slim CTV Best Group Inc. Duluth, GA bestslim.net Undeclared sibutramine Recall Drugs  
07/20/2012 X-Rock 3 Day Pill for Men CRM Laboratories Distributed by: XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312; or MATE Enterprises, 1020 N. Venetian Drive, Miami, Florida 33139 xrockhim.com Undeclared sildenafil and hydroxythiohomosildenafil Recall Drugs  
07/20/2012 Z-Rock CRM Laboratories Distributed By: XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312 zrockusa.com Undeclared sildenafil and hydroxythiohomosildenafil Recall Drugs  
06/01/2012 Reumofan Plus Riger Naturals S.A. n/a n/a Undeclared dexamethasone, diclofenac sodium and methocarbamol News Release Drugs

Consumer Update

Recalls

05/25/2012 Mojo Nights Various Distirbutors n/a n/a Undeclared sulfoaildenafil, sulfosildenafil, and hydroxythiohomosildenafil Public Notification Drugs  
05/25/2012 Kaboom Action Strips Various Distributors n/a kaboomformen.com Undeclared sulfoaildenafil Public Notification Drugs  
05/22/2012 EreXite Various Distributors n/a amazon.com Undeclared tadalafil Public Notification Drugs  
05/18/2012 Libidron West Coast Nutritionals, Ltd. n/a libidron.com; amazon.com Undeclared tadalafil Recall Drugs  
05/18/2012 Firminite West Coast Nutritionals, Ltd. n/a firminite.com; amazon.com Undeclared tadalafil Recall Drugs  
05/18/2012 Extra Strength Instant Hot Rod West Coast Nutritionals, Ltd. n/a instanthotrodextrastrength.com; amazon.com Undeclared tadalafil Recall Drugs  
05/16/2012 VMaxx Rx Various Distributors n/a vmaxxrx.com Undeclared sulfoaidenafil Public Notification Drugs  
05/16/2012 Boost — Ultra Sexual Enhancement Formula Various Distributors n/a boostultra.biz Undeclared  Public Notification Drugs  
04/20/2012 ZenMaxx Enhance Nutraceutical Malaysia zenmaxx.com Undeclared  aminotadalafil Public Notification Drugs Warning Letter
04/20/2012 Instant Hard Rod Enhance Nutraceutical Malaysia instanthardrod.com Undeclared aminotadalafil Public Notification Drugs Warning Letter
04/20/2012 RigiRx Plus Enhance Nutraceutical Malaysia rigirxplus.com Undeclared aminotadalafil Public Notification Drugs Warning Letter
04/05/2012 African Black Ant Various Distributors n/a ebay.com Undeclared sildenafil and tadalafil Public Notification Drugs  
04/05/2012 France T253 Various Distributors n/a ebay.com Undeclared sildenafil Public Notification Drugs  
04/03/2012 Japan Rapid Weight Loss Diet Pills Yellow Xiushentang n/a ebay.com Undeclared sibutramine and phenolphthalein Public Notification Drugs  
04/03/2012 Japan Rapid Weight Loss Diet Pills Green Xiushentang n/a ebay.com Undeclared phenolphthalein Public Notification Drugs  
02/22/2012 Mince Belle Healthy People Co. 13105 Ramona Blvd Ste F, Irwindale, CA, 91706 n/a Undeclared sibutramine Recall Drugs  
02/22/2012 Everlax Healthy People Co. 13105 Ramona Blvd Ste F, Irwindale, CA, 91706 n/a Undeclared sibutramine Recall Drugs  
02/22/2012 Ever Slim Healthy People Co. 13105 Ramona Blvd Ste F, Irwindale, CA, 91706 n/a Undeclared sibutramine Recall Drugs  
02/22/2012 Ever Slim Shake Mix Healthy People Co. 13105 Ramona Blvd Ste F, Irwindale, CA, 91706 n/a Undeclared sibutramine Recall Drugs  
02/22/2012 Acai-Man Mangosteen Herbal Drink Healthy People Co. 13105 Ramona Blvd Ste F, Irwindale, CA, 91706 n/a Undeclared tadalafil Recall Drugs  
02/22/2012 Perfect Men Healthy People Co. 13105 Ramona Blvd Ste F, Irwindale, CA, 91706 n/a Undeclared tadalafil Recall Drugs  
02/18/2012 Japan Weight Loss Blue Various Distributors n/a vitaminbestbuy.com Undeclared sibutramine and ephedrine alkaloids Public Notification Drugs  
02/18/2012 Man King Various Distributors n/a vitaminbestbuy.com Undeclared sildenafil Public Notification Drugs  
02/18/2012 Hard Ten Days Various Distributors n/a n/a Undeclared sildenafil Public Notification Drugs  
02/10/2012 RegenArouse Regeneca, Inc. n/a n/a Undeclared tadalafil Recall Drugs  
11/10/2011 Virility Max Keime Inc dba Barry's Vitamins n/a n/a Undeclared sulfoaildenafil Recall Drugs  
10/18/2011 A-Slim 100% Natural Slimming Capsule H&S GMP Factory n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 Health Slimming Coffee Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 Leisure 18 Slimming Coffee Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 P57 Hoodia Huikng Pharmaceutical n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 Magic Slim Weight Reduction Capsule Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 Sheng Yuan Fang Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 PhentraBurn Slimming Capsules Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 Tengda Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 Acai Berry Soft Gel ABC Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 Fruit Plant Lossing Fat Capsule Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 Botanical Slimming Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 Pai You Guo Slim Tea Various Distributors n/a n/a Undeclared sibutramine and phenolphthalein Public Notification Drugs  
10/18/2011 Lose Weight Coffee Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 DaiDaiHuaJiaoNang Various Distributors n/a n/a Undeclared sibutramine and phenolphthalein Public Notification Drugs  
10/18/2011 Advanced Slim 5 Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 Magic Slim Tea Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 Ja Dera 100% Natural Weight Loss Supplement Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/18/2011 Slender Slim 11 Various Distributors n/a n/a Undeclared sibutramine Public Notification Drugs  
10/03/2011 Uprizing 2.0 Superior Metabolic Technologies Inc Marietta, GA n/a Undeclared superdrol, a synthetic steroid Recall Drugs  
07/08/2011 Meizitang Botanical Slimming 100% Natural Soft Gel Intercharm Inc. Fort Lauderdale, FL n/a Undeclared sibutramine Public Notification Drugs Recall
07/08/2011 Slim Forte Slimming Coffee Intercharm Inc. Fort Lauderdale, FL n/a Undeclared sibutramine Public Notification Drugs Recall
07/08/2011 Slim Forte Slimming Capsules Intercharm Inc. Fort Lauderdale, FL n/a Undeclared sibutramine Public Notification Drugs Recall
07/08/2011 Slim Forte Slimming Capsule LA Beauty Store, Inc. n/a n/a Undeclared sibutramine Public Notification Drugs  
07/08/2011 Slim Forte Double Power Slimming Capsules LA Beauty Store, Inc. n/a n/a Undeclared sibutramine Public Notification Drugs  
05/29/2011 ViaXtreme Various Distributors n/a n/a Undeclared sulfoaildenafil Public Notification Drugs  
05/10/2011 Slim Xtreme Herbal Slimming Capsule Globe All Wellness, LLC 2854 Stirling Rd Suite G
Hollywood, FL 33020
n/a Undeclared sibutramine Public Notification Drugs Recall
04/28/2011 Regenerect Ethos Environmental, Inc. n/a n/a Undeclared sulfoaildenafil Recall Drugs  
03/28/2011 THE BEST Enhancement Supplement AVNS Inc n/a n/a Undeclared sulfoaildenafil Recall Drugs  
03/25/2011 Male Enhancer USA Far Ocean Group Inc. 1609 W. Valley Blvd., #338, Alhambra, CA 91803 n/a Undeclared tadalafil Recall Drugs  
03/25/2011 X-Hero USA Far Ocean Group Inc. 1609 W. Valley Blvd., #338, Alhambra, CA 91803 n/a Undeclared sulfosildenafil Recall Drugs  
03/22/2011 U-Prosta USA Far Ocean Group Inc. 1609 W. Valley Blvd., #338, Alhambra, CA 91803 n/a Undeclared terazosin Recall Drugs  
03/16/2011 Black Ant Various Distributors n/a n/a Undeclared sildenafil Public Notification Drugs  
02/24/2011 RegenErect Regeneca, Inc. n/a n/a Undeclared tadalafil Recall Drugs  
02/22/2011 Extenze Tablets Biotab Nutraceuticals, Inc. n/a n/a Undeclared tadalafil and sildenafil Recall Drugs News Release
02/11/2011 Svelte 30  Svelte 30 Nutritional Consultants Kissimmee, FL svelte.com Undeclared sibutramine Recall Drugs  
01/31/2011 Fruta Planta Godi International, Corp. FL n/a Undeclared sibutramine Recall Drugs  
01/31/2011 Reduce Weight Fruta Planta Godi International, Corp. FL n/a Undeclared sibutramine Recall Drugs  
01/18/2011 Nite Rider Maximum Sexual Enhancer For Men Kanec USA Inc n/a n/a Undeclared sildenafil Recall Drugs  
01/18/2011 STUD Capsule for Men Kanec USA Inc n/a n/a Undeclared sildenafil Recall Drugs  
01/12/2011 Celerite Slimming Capsules Shaping Beauty, Inc. Southampton, PA celeriteweightloss.com; shapingbeauty.com Undeclared sibutramine Public Notification Drugs Recall
01/03/2011 Reduce Weight Fruta Planta PRock Marketing LLC N/A frutaplanta.com Undeclared sibutramine Recall Drugs  
12/30/2010 Passion Coffee Drive Total Energy n/a drivetotalenergy.com Undeclared sulfoaildenafil Public Notification Drugs  
12/30/2010 RockHard Extreme Drive Total Energy n/a drivetotalenergy.com Undeclared sulfoaildenafil Public Notification Drugs  
12/22/2010 Fruta Planta PRock Marketing LLC n/a frutaplanta.com Undeclared sibutramine Public Notification Drugs Recall
12/22/2010 Pandora  RockHard Laboratories n/a n/a Undeclared analogue of Sildenafi Recall Drugs  
12/22/2010 RockHard Weekend RockHard Laboratories n/a n/a Undeclared analogue of Sildenafi Recall Drugs  
12/15/2010 Man Up Now Synergy Distribution LLC n/a n/a Undeclared sulfoaildenafil News Release Drugs  
11/19/2010 Vigor-25 Piston Corp. n/a n/a Undeclared sildenafil News Release Drugs  
10/27/2010 Duro Extend Capsules For Men Intelli Health Products 80 Southwest 8th Street
Miami, FL 33130
n/a Undeclared sulfoaidenafil Recall Drugs Expanded Recall
10/08/2010 Slimming Beauty Bitter Orange Slimming Capsules Beautiful Health Inc. n/a n/a Undeclared sibutramine News Release Drugs  
10/07/2010 Novedex XT Gaspari Nutrition Incorproated 575 Prospect Street - Suite 230, Lakewood, NJ n/a Contains 3,17-keto-etiocholetriene, also known as ATD News Release Drugs  
09/16/2010 Arom-X Capsules Advanced Muscle Science 4590 Deodar St., Silver Springs, Nevada 89429 n/a Contains 1,4,6 etioallocholan-dione, also known as ATD Recall Drugs  
09/16/2010 Arom-X UTT Liquid Advanced Muscle Science 4590 Deodar St., Silver Springs, Nevada 89429 n/a Contains 1,4,6 etioallocholan-dione, also known as ATD Recall Drugs  
09/16/2010 Arom-XL Liquid Advanced Muscle Science 4590 Deodar St., Silver Springs, Nevada 89429 n/a Contains 1,4,6 etioallocholan-dione, also known as ATD Recall Drugs  
09/16/2010 4-AD Capsules Advanced Muscle Science 4590 Deodar St., Silver Springs, Nevada 89429 n/a Contains 1,4,6 etioallocholan-dione, also known as ATD Recall Drugs  
09/16/2010 Decavol Capsules Advanced Muscle Science 4590 Deodar St., Silver Springs, Nevada 89429 n/a Contains 1,4,6 etioallocholan-dione, also known as ATD Recall Drugs  
09/16/2010 Reversitol Tribravus Enterprises, LLC d/b/a/ iForce Nutrition, LLC 1305 Hot Spring Way #103, Vista CA 92081 n/a Contains 6-Etioallochol-1,4-Diene-3,17-Dione, also known as ATD Recall Drugs  
09/15/2010 Off Cycle II Hardcore Fizogen Precision Technologies 3133 Fortune Way, Suite #4, Wellington, FL 33414 n/a Contains 3,17-keto-etiochol-triene, also known as ATD Recall Drugs  
09/14/2010 Clomed KiloSports Inc. Phoenix, AZ n/a Undeclared aromatase inhibitor Recall Drugs  
09/13/2010 ArimaDex Genetic Edge Technologies Phoenix, AZ n/a Undeclared aromatase inhibitor News Release Drugs  
08/25/2010 TimeOut Capsules Various Distributors n/a n/a Undeclared hydroxythiohomosildenafil News Release Drugs  
08/18/2010 Mr. Magic Male Enhancer from Don Wands Glow Industries, Inc. Perrysburg, OH n/a Undeclared hydroxythiohomosildenafil and sulfoaildenafil Recall Drugs  
08/10/2010 Stiff Nights Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Aziffa Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Size Matters Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Erex Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Mojo Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Hard Drive Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Eyeful Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Red Magic Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Straight Up Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Zotrex Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Monster Excyte Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 WOW Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Xaitrex Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Verect Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Prolatis Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Xytamax Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Maxyte Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Libidinal Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 OMG Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 OMG45 Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/10/2010 Zilex (with Golden Spear) Novacare LLC Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/09/2010 Prolatis' Prolatis' Salt Lake City, UT n/a Undeclared sulfoaildenafil Recall Drugs  
08/06/2010 Solo Slim® EZVille, Ltd. Ronkonkoma, NY n/a Undeclared didesmethyl sibutramine Recall Drugs  
08/06/2010 Revivexxx® Extra Strength EZVille, Ltd. Ronkonkoma, NY n/a Undeclared tadalafil Recall Drugs  
07/28/2010 Ejaculoid XXTREME Nutraloid Labs Inc. Kingston, NY n/a Undeclared sulfoaildenafil Recall Drugs  
07/28/2010 Stimuloid II Nutraloid Labs Inc. Kingston, NY n/a Undeclared sulfoaildenafil Recall Drugs  
07/22/2010 Joyful Slim Herb Supplement J & H Besta Corp. Hicksville, NY n/a Undeclared desmethyl sibutramine Recall Drugs  
07/16/2010 Slim-30 Herb Supplement J & H Besta Corp. Hicksville, NY n/a Undeclared N-desmethyl sibutramine Recall Drugs Expanded Recall
07/16/2010 Vialipro  Good Health, Inc. Canutillo, TX n/a Undeclared sulfoaildenafil Recall Drugs  
07/08/2010 Que She Various Distributors n/a n/a Undeclared fenfluramine, propanolol, sibutramine, ephedrine Recall Drugs  
06/19/2010 Magic Power Coffee INZ DISTRIBUTORS INC./MAGIC POWER COFFEE INC. Brooklyn, NY n/a Undeclared hydroxythiohomosildenafil News Release Drugs

Recall

Consumer Update

06/04/2010 Rock Hard Weekend Atlas Operations, Inc. 325 Sw 15th Ave, Pompano Beach, FL 33069-3246 n/a CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated Warning Letter Drugs  
06/04/2010 On Cycle II Hardcore Atlas Operations, Inc. 325 Sw 15th Ave, Pompano Beach, FL 33069-3246 n/a CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated Warning Letter Drugs  
06/04/2010 Sleep Quick Strips Atlas Operations, Inc. 325 Sw 15th Ave, Pompano Beach, FL 33069-3246 n/a CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated Warning Letter Drugs  
06/04/2010 Sleep Once Again Atlas Operations, Inc. 325 Sw 15th Ave, Pompano Beach, FL 33069-3246 n/a CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated Warning Letter Drugs  
06/04/2010 Sleep Ease Atlas Operations, Inc. 325 Sw 15th Ave, Pompano Beach, FL 33069-3246 n/a CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated Warning Letter Drugs  
06/04/2010 Insomnix Atlas Operations, Inc. 325 Sw 15th Ave, Pompano Beach, FL 33069-3246 n/a CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated Warning Letter Drugs  
06/04/2010 Musclextreme Pump Extreme Atlas Operations, Inc. 325 Sw 15th Ave, Pompano Beach, FL 33069-3246 n/a CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated Warning Letter Drugs  
06/04/2010 Derma-Tropin Atlas Operations, Inc. 325 Sw 15th Ave, Pompano Beach, FL 33069-3246 n/a CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated Warning Letter Drugs  
06/04/2010 GH.X Growth Hormone Extreme Atlas Operations, Inc. 325 Sw 15th Ave, Pompano Beach, FL 33069-3246 n/a CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated Warning Letter Drugs  
04/20/2010 Vitalex Vitapro, Inc. CA n/a Undeclared acetildenafil-analog  News Release Drugs  
04/12/2010 Amour Again for Him Atlas Operations, Inc. Pompano Beach, FL n/a Undeclared sulfoaildenafil Recall Drugs  
04/12/2010 Erectzia Atlas Operations, Inc. Pompano Beach, FL n/a Undeclared sulfoaildenafil Recall Drugs  
04/12/2010 Ere-xxx by Elite Body Atlas Operations, Inc. Pompano Beach, FL n/a Undeclared sulfoaildenafil Recall Drugs  
04/12/2010 Ere-xxx by Maxi Elit Atlas Operations, Inc. Pompano Beach, FL n/a Undeclared sulfoaildenafil Recall Drugs  
04/12/2010 Stamin It Atlas Operations, Inc. Pompano Beach, FL n/a Undeclared sulfoaildenafil Recall Drugs Warning Letter
04/12/2010 Vigor 100 Atlas Operations, Inc. Pompano Beach, FL n/a Undeclared sulfoaildenafil Recall Drugs  
04/12/2010 Whatz Up Rx Atlas Operations, Inc. Pompano Beach, FL n/a Undeclared sulfoaildenafil Recall Drugs  
04/02/2010 Stud Capsule Kanec USA Inc. 5061 South State Road 7. Ste 602, Davie FL 33314 n/a Undeclared sildenafil Recall Drugs  
03/30/2010 MasXtreme Natural Wellness Inc. 440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441 n/a Undeclared aildenafil and phentolamine; undeclared aminotadalafil  Recall Drugs Expanded Recall
01/15/2010 Advanced Muscle Science Dienedrone MuscleMaster.com, Inc. Northborough, MA n/a Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol" Recall Drugs  
01/15/2010 Advanced Muscle Science Liquidrone MuscleMaster.com, Inc. Northborough, MA n/a Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"