18 More in 18 Days: FDA's Sanitizer Hot List Just Got Longer

Since our most recent report 18 days ago (at press), the U.S. Food and Drug Administration (FDA) has added 18 new product entries to its "Do Not Use" hand sanitizer list for potential and known methanol content, as well as possible sub-potent efficacy. In relation, several companies have voluntarily recalled suspect hand sanitizer products.

The latest entries to the FDA's Do Not Use list include products from Mexico, Turkey and Guatemala. As previously reported, methanol or methyl alcohol, also known as wood alcohol, is used to make rocket fuel and antifreeze and is quite toxic. It should never be rubbed onto the skin or swallowed. Swallowing or drinking hand sanitizers contaminated with methanol can cause serious health problems, including permanent blindness, and death.

See related: FDA Raises Methanol Alarm with Import Alert; Adverse Events, Deaths Reported

Regarding efficacy, the CDC reminds consumers who are on the go to use hand sanitizer that contains at least 60% alcohol to kill germs. In addition, where possible, soap and water are recommended to fully remove microbes from hands. 

Following is an update of the flagged manufacturers as of 9/11/2020; multiple products and brands from these companies are entered in the FDA's continuosly updated Do Not Use list.

The Hot List

• 4E Global, SAPI de CV (Mexico)
• AAA Cosmetica (Mexico) - more products flagged for possible methanol
• Albek de Mexico Sa de CV (Mexico)
• Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico) - NEW - flagged for possible methanol
• Asiaticon SA de CV (Mexico)
• Botanicals Internacional SA de CV (Mexico)
• Broncolin, SA de CV (Mexico)
• DDI Multinacional SA de CV (Mexico)
• DEPQ Internacional S de RL de CV (Mexico)
• DMM Vission SA de CV
• Eskbiochem SA de CV (Mexico)
• Estrategia Hospitalaria SA de CV (Mexico)
• Genesis Partnership Company SA (Guatemala) - NEW - possible subpotency reported
• Grupo Asimex de Mexico Sa de CV(Mexico)
• Grupo Insoma, S.A.P.I de CV (Mexico)
• Grupo Plast Y Kosas SA de CV (Mexico)
• Grupo Yacana Mexico SAS de CV (Mexico)
• Harmonic Nature S de RL de MI (Mexico) (Mexico)
• Healthy Foods & Nutrition Lab de Mexico SA de CV (Mexico)
• Ignacio Reyes Gonzalez
• Industrias Class S de RL de CV (Mexico) - NEW- possible methanol content
• Incredible Products SA de CV (Mexico)
• Ismar Soluciones Dinámicas S de RL de CV (Mexico)
• JG Atlas Comercios SA de CV (Mexico)
• Jose Miguel Gutierrez Salas(Mexico)
• Laboratorios Jaloma, SA de CV (Mexico)
• Leiper's Fork Distillery (Tennessee, USA)
• Limpo Quimicos SA de CV (Mexico)
• Liqesa Exportacion or Liq-E-S.A. de CV (Mexico)
• Maquiladora Miniara, SA de CV (Mexico)
• MXL Comercial SA de CV (Mexico)
• MYM Hidrominerales SA de CV (Mexico)
• Mystic International SA de CV (Mexico)
• Nanomateriales SA de CV (Mexico)
• Neoingenium Labs SA de CV Hand Sanitizer (Mexico) - NEW - possible methanol content
• Notarika SA de CV (Mexico)
• Noticias Mexico Hoy Grupo Multimedia (Mexico)
• Open Book Extracts (North Carolina)
• Plastico Las Palmas SA de CV (Mexico)
• Precision Analitica Integral SA de CV (Mexico)
• Quimica Magna de Mexico SA de CV (Mexico)
• Real Clean Distribu­ciones SA de CV (Mexico)
• Roque Plast SA de CV (Mexico)
• Santa Cruz Biotechnology (Texas)
• SCK Zeta Dis Ticaret Pazarlama Ltd. (Turkey) - NEW - possible methanol content
• SG24 LLC (Georgia)
• Soluciones Cosmeticas SA de CV (Mexico)
• Spartan Chemical Co Inc. (Ohio)
• Tritanium Labs USA LLC (Illinois)
• Tropicos­meticos SA de CV (Mexico)
• Volu-Sol Inc. (Utah)
• Yangzhou Olande Cosmetic Co. Ltd. (China)
• Yara Elena De La Garza Perez Nieto (Mexico)

Voluntary Recalls

In relation, within the past 18 days (at press) several companies have issued voluntary hand sanitizer recalls for various issues, cited as follows:

• CorgioMed LLC recalled all lots of Leafree Instant Hand Sanitizer Aloe Vera labeled as Edible Alcohol;
• Medek, LLC recalled M Hand Sanitizer due to the possible presence of methanol and sub-potent ethanol levels;
• AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer;
• Open Book Extracts issued a voluntary recall of all lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer, due incorrect labeling for methanol content;
• Harmonic Nature recalled its namesake sanitizer due to 1-propanol content;
• Nanomateriales, SA de CV issued a voluntary recall on all lots of its Zanilast+gel due to the presence of 1-propanol; and
• Asiaticon SA de CV issued a voluntary recall of V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel and Protz Real Protection Antibacterial Hand Sanitizer due to possible methanol content and sub-potent ethanol levels.

For the continuous list of recalls, market withdrawals and market alerts, see the FDA website.

See related: [video] Cosmetics R&D Vlog: Formulating Sanitizers By the Book