OTC Warning Letters

2000-2011 Warning Letters are archived. To view them, please see the FDA Archive

• Acne
• Anorectals
• Antacids
• Antimalarials/Leg Cramps/Quinine
• Anthelmintics
• Antifungals
• Aphrodisiacs
• Cold and Cough
• Corn and Callous Removers
• Cosmetics with Drug Claims
• Dandruff, Seborrheic Dermatitis and Psoriasis
• External Analgesics
• Internal Analgesics/Antipyretic/Antirheumatic
• Male Genital Desensitizers
• Nicotine Products
• Ophthalmics
• Pediculicides
• Skin Protectants/Skin Barriers
• Sleep Aids/Sedatives/Stimulants
• Stimulants
• Sunscreens
• Topical Antibiotics
• Topical Antimicrobials
• Topical Hormone Replacement
• Vaginal Contraceptives
• Wart Removers  

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This is not an inclusive list and is not meant to reflect Agency priorities

Acne

 

Anorectals

• Tarmac Products, Inc. – “Hemorrodil” and “Hemorrodil Plus Hemorrhoidal Ointment with Hidrocortisone 1%” - 2011

Antacids 

• Seindni Co., Ltd. - 2018

• Prosana Distribuciones S.A. de C.V. – “Bicaruvas” – 2017

• Tarmac Products, Inc. – “ Estomaquil” – 2011

Antimalarials/Leg Cramps/Quinine 

• Standard Homeopathic Company – “Leg Cramps with Quinine Tablets” – 2011

Anthelmintics 

• Tarmac Products, Inc. – “Vermocks Tableta” and “Vermocks Suspension” – 2011

Antifungals

• Anicare Pharmaceuticals Pvt Ltd. – 2019

• Scientific Solutions Global LLC – 2019

• Tarmac Products, Inc. – “Sanafitil Antifungal Lquid” - 2011

Aphrodisiacs 

• JIIM, L.L.C. – “Doctors’s Lotion” - 2000

Cold and Cough

•  TG Untited, Inc. - 2019

• Glint  Cosmetics Pvt Ltd - 2019

• JT Cosmetics & Chemicals Pvt. Ltd. – 2018

• DrNaturalHealing Inc. - epinephrine-containing capsules and dry powder inhaler  - 2016

Corn and Callous Removers

• Scientific Solutions Global LLC – 2019

Cosmetics with Drug Claims

• AMMD  Labs, LLC - 2019

Dandruff, Seborrheic Dermatitis and Psoriasis

• Soleo - 2018

External Analgesics

• Haw Par Healthcare Limited - 2019

• Scientific Solutions Global LLC – 2019

• Ingenue Care - 2019 

• Laboratorios Quantium LLC - 2019

• Anicare Pharmaceuticals Pvt Ltd. – 2019

• Wong Lap Kwong Medicine Company Limited – 2018

• Wong Lap Kwong Medicine Company Limited – external analgesic oils – 2017

• A.I.G. Technologies Inc. – “Derma Numb Tattoo Anesthetic Spray” – 2017

• Ridge Properties, LLC dba Pain Relief Naturally - External Analgesics – 2017

• Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. - "Piyanping Anti-Itch Lotion" - 2017  

• Anastasia Marie Laboratories, Inc. - 2013

• Health Care Products, Hi-Tech Pharmacal Co. - 2013

Internal Analgesics/Antipyretic/Antirheumatic 

• GnuPharma Corporation – 2017

• American Family Pharmacy, LLC – "Aspirin Enteric Safety Coated Tablets" - 2015

• Tarmac Products, Inc. – “Neomeolubryna” – 2011

• Fasprin Health, LLC / Nobel Laboratories, LLC – “Fasprin” – 2010

• Procter and Gamble - "VICKS DayQuil Plus Vitamin C" and "VICKS NyQuil Plus Vitamin C" – 2009

• Bayer HealthCare L.L.C. – “BAYER WOMEN'S Low Dose Aspirin + CALCIUM” - 2008

• Bayer HealthCare L.L.C. – “BAYER ASPIRIN With HEART ADVANTAGE” – 2008

• Direct Dispensing, Inc. - “ACETAMINOPHEN”, “ASPIRIN ENTERIC COATED”, “ASPIRIN-EC DELAYED-RELEASE ENTERIC COATED”, “DIPHENHYDRAMINE HCL”, “PSEUDOEPHEDRINE HCL” - 2006

• Omni Nutraceuticals, Inc. – “INHOLTRA JOINT PAIN CAPLETS and INHOLTRA JOINT PAIN PLUS CAPLETS” – 2001

• B.F. Ascher & Company, Inc. – “MELAGESIC™ PM CAPLETS” – 2001

Male Genital Desensitizers

• Cerno Pharmaceuticals, LLC -2018

Nicotine Products

• Smokers-mall - 2016

• Cixi E-Cig Technology Inc, Ltd. - "E-Cig Technology products” – 2010

• E-CigaretteDirect, LLC – “Gamucci,”“Smoking Everywhere,” and “Veppo” – 2010

• Gamucci America - “Gamucci Electronic Cigarettes and Cigars”– 2010

• Johnson Creek Enterprises, LLC – “Smoke Juice” – 2010

• Ruyan America, Inc. – “RUYAN V-8”, “RUYAN RAPP E-Mystick”, “RUYAN Vegas”, “RUYAN e-Gar”, “Rosewood E-Pipe”, and “Agate E-Pipe” – 2010

• Omega Tech Labs.,LLC – “Stop” – 2008

• Customs Scripts Pharmacy – “Nicotine Lollipops” – 2006

• Spoonamore Drug Co., Inc. – “Nicotine Lollipops” – 2006

• Ashland Drug – “Nicotine Lollipops” – 2002

• Bird’s Hill Pharmacy – “Nicotine Lollipops” – 2002

• The Compounding Pharmacy & Techni-Med, Inc. – “Nicotine Lollipops” and “Nicotine Lip Balm” – 2002

Ophthalmics

• Focus Laboratories, Inc. – “FreshKote®” – 2016

Pediculicides

• True Renewal – “Graviola” and “Graviola Max” – 2009

• Heartland Products, Inc. – “Lice Arrest™” - 2007

• Wallace O'Farrell Marketing, Inc. aka, Wal-Med, Inc. – “Lice-Out” and “Lice-Trap” – 2007

Skin Protectants/Skin Barriers

• Ningbo Pulisi Daily Chemical Products Co., Ltd - 2019

• Hangzhou Karic Commodities Co., Ltd. - 2018

• Seindni Co., Ltd.- Skin Protectants  – 2017

• Benchmark Medical – “DermaShield”, “DermaPlus”, and “DermaMed” – 2006

Sleep Aids/Sedatives/Stimulants

• B.F. Ascher & Company, Inc. – “MELAGESIC PM CAPLETS” - 2001

Stimulants

• alvSupplement Direct – “Anhydrous Caffeine Bulk Powder” - 2016

Sunscreens

• Enprani Co., Ltd. – 2019
   
• Clover Custom Blending LLC – 2018

• Seindni Co., Ltd.- Skin Protectants  – 2017

• Colabs INTL Corp. - KLĒNSKIN sunscreen product line - 2016

• Diamond Wipes International, Inc. - "LA FRESH travel-lite Sunscreen Wipe SPF 30 - 2016

• Holding Company of MD MOM® LLC. - “MD MOM® Babysafe Sunscreen Towelettes Broad Spectrum SPF30” - 2016

• Jaychem Industries - GolfersSkin - 2015 

Topical Antibiotics

• Anicare Pharmaceuticals Pvt Ltd. – 2019

• Tarmac Products, Inc. – “Ampitrexyl Antibiotico” – 2011

Topical Antimicrobials

• Proandre SL – 2019

• Xi'an  Livingbond Nonwoven Products Corp., Ltd. – 2019

• Degasa S.A. De C.V. - 2018

• Longwood Medicine (Beijing) Co Ltd - 2018

• Innovative Biodefense Inc. 2015  - Zylast antiseptic product line, including Zylast XP Antiseptic, Zylast XP Antiseptic Foaming Soap, and Zylast XP Antiseptic Lotion (collectively, the Zylast products)

• JD Nelson and Associates, LLC – “Safe4Hours Hand Sanitizing Lotion” and “Safe4Hours First Aid Antiseptic Skin Protectant” – 2011

• Procter and Gamble – “Vicks Early Defense Foaming Hand Sanitizer” - 2007

Topical Hormone Replacement

• Bio-Health  A Division of Zlabs LLC  “Z-LABS - Progesterone Cream” – 2005

• HMS Crown, Inc. – “HMS Queen's Progesterone” and “HMS King's Progesterone” – 2005

• One Life USA – “Barbec Basics Natural Progesterone Cream” – 2005

Vaginal Contraceptives

• Optima Worldwide, Ltd. – “GEDA PLUS” and “SURETE” - 2000 

Wart Removers

• Cerno Pharmaceuticals, LLC -2018

• Solace International, Inc. - Derma Tend Original Mole, Wart, Skin Tag Remover – 2014