Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. Report any health product adverse events or complaints to Health Canada. 75339-751-05 The dangers of drinking any hand sanitizer under any conditions. HAN Archive - 00434 | Health Alert Network (HAN) - Centers for Disease 79279-521-01 This organic hand sanitizer, which contains 62% alcohol, is formulated with glycerin and dimethicone, which together help hydrate and moisturize the skin, according to EO . Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child. Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic Hand Rub, Non-Sterile Solution. If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product. The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. 74046-006-02 08/11/2020. The agency continues to add certain hand sanitizers to theimport alertto stop these products from legally entering the U.S. market and has issued warning letters to companies that violate federal law. Products that are fraudulently marketed as FDA-approved since there are no hand sanitizers approved by FDA. Consumers can easily identify which hand sanitizer products to avoid by using the following information: Distributors may use more than one manufacturer to produce their hand sanitizer products, which are then marketed under the exact same brand or product name. 74046-006-07 Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. FDA recommended the company recall on 06/01/2022. Safety officials at the Food and Drug Administration are warning Americans that not all hand sanitizers are made equal,. Flavor Vapors, LLC, dba: Mob Liquid Labs Is being recalled by the manufacturer or distributor. 74721-0001-5 Consumer and health care professional safety is a top priority for FDA, and an important part of FDAs mission is to protect the public from harm, especially as we seek to help increase hand sanitizer supply. 79279-420-03 Updated: Jul 13, 2020 / 11:49 AM PDT. Zorin Pharmaceutical Technology Co. Ltd. (China), Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/12/2022, Biotipo Pharma Medical Sanitizing Hand Wipes, PalmShield Hand Sanitizer Gel with Aloe and Coconut Oil. 71120-112-05 74046-004-04 FDA recommended the company recall all drug products on 12/12/2022. 79279-520-06 Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Guangzhou Minghui Cosmetics Co. Ltd. (China), Product purported to be made at the same facility that produced subpotent ethyl alcohol product;added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued awarning letteron 07/06/2021; product voluntarily recalled by Native Promotions, Inc. on 7/12/2021, Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. 74046-001-09 GSD Advanced Hand Sanitizer - 80% Alcohol Based - ( 1 Litter ( 33.2 OZ 74721-0001-4 74046-001-11 Company did not respond adequately to multiple FDA requests for records and other information related to drug manufacturing, product quality and questions regarding possibility of methanol contamination which cannot be ruled out; after FDA recall recommendation, the firm announced a voluntary recall on 10/18/2022; FDA issued a warning letter on 12/20/2022. GSD Disinfecting Sanitizing Wipes can be used for everyone. Acetal can irritate the upper respiratory tract, eyes, and skin. April 30, 2021 -- Nearly a dozen scented hand sanitizer sprays sold at Ulta, TJ Maxx, and Marshalls stores nationwide are being recalled because they may be contaminated with methanol, a. 74046-001-20. FDA expands hand sanitizer recall to at least 75 brands across the U.S. $80.00. [3/25/2021] FDA is warning consumers and health care professionals not to use Durisan Antimicrobial Solutions Hand Sanitizer manufactured by Sanit Technologies LLC doing business as Durisan in Sarasota, Florida, due to microbial contamination. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. The product, which contains 70% ethyl alcohol gel, comes in 8-ounce bottles and is intended to be . 74721-0010-2 Sophora Extract Testing ethanol for methanol contamination is a quality standard set by the United States Pharmacopeia (USP) for alcohol used in pharmaceuticals (including hand sanitizers) and enforced by FDA pursuant to section 501(b) of the FD&C Act. 74530-011-08, 74530-013-01 74721-0010-9 If soap and water are not readily available, theCenters for Disease Control and Prevention(CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol). [8/12/2020] FDA is warning consumers and health care professionals about certain hand sanitizer products, including those manufactured by Harmonic Nature S de RL de MI in Mexico, that are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination. 79279-520-07 9 brands of hand sanitizer may be toxic, FDA warns - CBS News Hand sanitizer recalled because it may cause methanol poisoning GSD All-Purpose Anti-Bacterial Wipes | 80 Wipes per Packet (Michigan). On March 26, students, faculty and staff were notified in an email from Yale's Environmental Health & Safety Department, or EHS, that benzene, a substance that can cause cancer, was detected in two hand sanitizer brands distributed by Yale, CleanHands and ArtNaturals, and were asked to dispose of the hand . FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023. FDAs investigation of methanol in certain hand sanitizers is ongoing. Last updated on May 17, 2022. 74046-004-09 74721-0010-6 74046-001-13 74530-013-08, 74530-012-01 74721-0020-1 FDA recommended the company recall on 9/14/2022; product voluntarily recalled lot 1166A on 9/17/2022; FDA issued a warning letter on 12/21/2022. Medically Minded Hand Sanitizer Gel V-KLEAN DermX70 Hand Sanitizer (only includes 250mL, 500mL and 1000mL sized packages) V-KLEAN Hand Sanitizer Gel V-KLEAN Hand Sanitizer Gel. Additionally, any alcohol (ethanol) or IPA found to contain more than 630 ppm methanol does not fall within the policies described in the temporary guidances and may be considered evidence of substitution and/or contamination. Consumers who have products on thelist of hand sanitizerswith potential methanol or 1-propanol contamination should immediately stop using the product and dispose of it, ideally in ahazardous waste container. 74046-001-04 74721-0020-0 Product purported to be made at the same facility that produced product containing acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. Kleanz Antibacterial Hand Sanitizer Advanced, Be Safe Hand Sanitizer (labeled with Model: BF-HGXXXX-09 where XXXX changes based on packaging size), Product manufactured at a facility that did not respond to multiple FDA requests for recordsrelated to drug manufacturing and product qualityeven afterreceiving a warning letter. A distributors products bearing the same brand name as listed below, but made by a different manufacturer, Other products distributed by the same distributor. Lukas Flippo, Photo Editor. 80969-010-02 74721-0020-5 Is purportedly made at the same facility as products that have been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAs MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product): [3/25/2021] FDA is warning consumers and health care professionals not to use Durisan Antimicrobial Solutions Hand Sanitizer manufactured by Sanit Technologies LLC doing business as Durisan in Sarasota, Florida, due to microbial contamination. Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. 74046-001-02 Harmonic Nature S de RL de MI (Mexico) FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/12/2020; added to import alert to stop products from entering the U.S. on 8/20/2020; product voluntarily recalled on 8/14/2020. Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. Alcohol Based Hand Sanitizer, Isopropyl Antiseptic 75%. Maridav/Shutterstock. FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/10/2020; added manufacturer to, Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to, Protec Hands Antibacterial Gel Topical Solution Non-sterile Solution, Smart Care hand sanitizer packaged in 0.84 fl oz. Cosmeticos Ltda, (Brazil), Biotipo Pharma Medical Antibacterial Antiseptic Cleanser Disinfectant, Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/18/2022, Reborncare Hand Sanitizer (100mL, 250mL, 500mL). Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers. FDA tested product; contains unacceptable levels of acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination. Disinfection Spray Chlorine Dioxide Ion (1-), PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose), 80969-006-01 71120-112-06 FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAs MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product): The following chart outlines the information on hand sanitizer labels for consumers to use to identify a product that: FDA advises consumers not to use hand sanitizers produced by the manufacturers identified in the table below. A hand sanitizer that was sold over the internet nationwide is being recalled because it may have been contaminated with toxic methanol. The company, Spartan Chemical, issued a recall for its "Lite 'n Foamy Lemon Blossom Hand Sanitizer" and "foamyiQ Lemon Blossom Hand Sanitizer" on July 1. 75821-001-02 Alcohol Free Disinfectant, Safe Cleaner Plus Health Canada has recalled several hand sanitizers across the country over the last two years over concerns of potential health risks from using the products. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. Do not pour these products down the drain or flush them. GSD All Purpose Liquid Sanitizer & Disinfectant FAMILY SIZE 1L (33.2 OZ) 80% alcohol, quick dry, with no residue. Individuals with compromised immune systems are at increased risk. Durisan tested its hand sanitizer and found microbial contamination including high levels of Burkholderia cepacia complex and Ralstonia pickettii, which can lead to serious infections, including infection of the skin, soft tissues, lungs or bloodstream. 80969-010-06 [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. 80969-007-01 When the FDA continues to issue recalls for the inclusion of potentially toxic ingredients (as of this release, the list of banned sanitizers has now surpassed 100), we all need a hand sanitizer . To date, the FDA's ongoing testing found methanol contamination in hand sanitizer products ranged from 1 percent to 80 percent. 74721-0002-2 Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. Keep all hand sanitizers out of the reach of children. FDA Adds 4 Brands Of Hand Sanitizer To Growing Recall List FDA test results show certain hand sanitizers have concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products. The alcohol (ethanol) or IPA should be destroyed following guidelines for hazardous waste and the manufacturer or compounder should contact FDA regarding the test results and the alcohols source. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 01/05/2023. Certain hand sanitizers are being recalled because they do not meet Health Canada's requirements. Additionally, any repackers who distribute hand sanitizers and other ethanol or isopropyl alcohol-based drugs, should know who they are purchasing from and conduct the necessary due diligence to ensure the drugs they sell are safe for consumers. 80969-040-04, PFA Stronghold Hand Sanitizer If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol). Hand Sanitizer Industrial and Hospital Grade, FDA tested product; ethyl alcohol level was subpotent; added to, Guangzhou Youxing Cosmetics Co. Ltd.(China), V&W Advance Hand Sanitizer Refreshing Gel, Guangzhou Youxing Cosmetics Co. Ltd. (China), V&W Moisturizing Refreshing Spray Sanitizer [isopropyl alc. Oct 9 2021, 10:23 am. Aloe Vera Based Hand And Skin Purifying Gel. Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. List of antiseptic or antibacterial skin cleansers or hand sanitizers meeting Health Canada's requirements for safety, effectiveness and quality, for use against coronavirus (COVID-19). Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning. According to the FDA, you should use an alcohol-based hand. 74530-011-02 GSD Advanced Hand Sanitizer - Gomer's of Kansas Anti-Bac Hand Sanitizer 65% Alcohol, Scent Theory Keep It Clean Pure Clean Anti-bacterial Hand Sanitizer, Cavalry (labeled with Product of Mexico), Natural Gold Gel Alcohol Antiseptic 75% Topical Solution, Command Gel AntiBac Instant hand sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 7/31/2020; product voluntarily, UltraCruz Hand Sanitizing Gel Antimicrobial, Company tested product; isopropyl alcohol level was subpotent; product voluntarily recalled lot BF12530 on 8/7/2020, Sanit Technologies LLC, doing business as Durisan (Florida), Durisan Antimicrobial Solutions Hand Sanitizer, Alcohol-Free, Company tested product; contains microbial contamination; product, Durisan Antimicrobial Solutions Hand Sanitizing Wipes, Alcohol-Free, New Wave Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%), Company tested product; manufacturing process lacks adequate controls to prevent microbial contamination. Unibeleza Industria E Comercio De This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. FDA has updated our guidances to provide clarification that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol if the ethanol or IPA is obtained from another source. 80969-008-01, 80969-010-01 [10/28/2021] FDA is alerting health care professionals and consumers of artnaturals voluntaryrecall of limited batches of 8 oz bottles of Scent Free Hand Sanitizer. Updated: Nov 9, 2022 / 01:55 PM EST. 74046-004-05 COVID-19: List of hand sanitizers authorized by Health Canada - Canada.ca MIAMI (CBSMiami) - The Food and Drug Administration has added four brands of hand sanitizer to a list of more than 75 that have been recalled. Call 9-1-1 if the person is unconscious or has trouble breathing. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 01/05/2023, 74046-004-01 In late June, the agency issued a warning against purchasing. 74046-001-16 FDA hand sanitizer recall widens to over 100 products 74721-0010-5 The .gov means its official.Federal government websites often end in .gov or .mil. This recall is being conducted with the knowledge of the FDA. 74046-001-10 Do not use these hand sanitizers according to FDA - Washington Post 79279-420-04 There's a nationwide spray hand sanitizer recall on 11 products that were sold at Ulta, TJ Maxx, and Marshalls stores. 74530-011-04 Picture Information. This comes after a series of recalls related to. Valisure . Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. 74046-001-12 The FDA listed the following products in its warning: All-Clean Hand Sanitizer (NDC: 74589-002-01) Esk Biochem Hand Sanitizer (NDC: 74589-007-01) CleanCare NoGerm Advanced Hand Sanitizer 75% . Grapefruit Extract, 74721-0001-1 74046-004-02 74530-013-05 That chemical, according to the recall posted on the U.S. Food and Drug Administration's website, is . 74046-004-03 Alcohol antiseptic 80% topical solution. Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. Transliquid. 74046-001-18 Cultivation Republic (Clearwater, Florida). No rinse needed, usable anywhere without water. On June 19, 2020, the U.S. Food and Drug Administration (FDA) advised consumers not to use any hand sanitizer manufactured by "Eskbiochem SA de CV" in Mexico, due to the potential presence of methanol, a "toxic alcohol", as an active ingredient, which can cause blindness and/or death when absorbed through the skin or when swallowed. Consumers should be aware that FDAs recommendation against using a distributors specific hand sanitizer product(s) manufactured by a particular manufacturer, as listed below, does not extend to: If a product on the list below does not identify the manufacturer on the label, consumers can contact the distributor whose name appears on the label to find out who manufactured the product. The affected products are packaged in 4-ounce, 8-ounce, 16-ounce, and one-gallon bottles and were sold through online sales and retail . If swallowed, call a poison control centre or seek medical help immediately. 74721-0020-2 Health Canada has recalled the following products . 75339-751-02 FDA tested product; contains unacceptable levels of acetaldehyde and acetal;Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023. GSD All Purpose Liquid Sanitizer & Disinfectant MEGA REFILL SIZE 1.75L (59.2 OZ) 80% ALCOHOL GSD All Purpose Liquid Sanitizer & Disinfectant FAMILY SIZE 1L (33.2 OZ) 80% ALCOHOL GSD All Purpose Liquid Sanitizer & Disinfectant POCKET SIZE 375mL (12.6 OZ) 73% Alcohol - Gel Sanitizer & Disinfectant With Essential Oils 73% ALCOHOL FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 09/27/2022; product voluntarily recalled on 9/27/2022. 74721-0001-2 Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021. 71120-612-06 The agency also included an additional denaturant formula in the temporary guidances. 74721-0002-6 Hand sanitizer recall: FDA expands list of 'toxic' sanitizers to avoid over methanol risk by: Alexa Mae Asperin. Hand sanitizer recall: FDA says Medically Minded brand found to contain Hand sanitizer recalled over potential methanol contamination 70% Alcohol Cleansing Gel Say Goodbye to Germs. The company recalled one lot of hand sanitizer: Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. Category: Hand Sanitizer. 75293-001-03 The agency first warned consumers in June about hand . 74046-006-08 The testing method (with appropriate validation) can be used for hand sanitizers labeled with either alcohol (ethanol) or isopropyl alcohol (also called isopropanol or 2-propanol) as the active ingredient and can screen for potentially harmful impurities, as listed in FDAs temporary guidances. Five more hand sanitizers were added to Health Canada's evolving recall list on Tuesday, which now includes more than 100 products that may pose health risks. Still more hand sanitizers recalled: Here's a list of brands to avoid Artnaturals Hand Sanitizer Infused with Jojoba Oil, Germ Free Anti-Bacterial Instant Hand Sanitizer, Apollo Instant Hand Sanitizer Anti Bacterial, Health & Wellness Essentials Hand Sanitizer Wash-Free, New Sanicol Advanced Antibacterial Hand Sanitizer, National Travel Products, Inc (New Jersey), 74530-015-01 The Food and Drug Administration has recalled more hand sanitizers with a new, deadly toxin bringing its growing "do not use" list to nearly 150 products. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination. product voluntarilyrecalledon 11/30/2021, Product labeled to contain methanol; FDA recommended the company recall on 12/6/2021; product voluntarily recalled on 12/6/2021, Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to, Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. 74721-0010-7 (China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 The hand sanitizers include brands sold at Sam's Club and BJ's Wholesale Club. The new additions cont Recalled hand sanitizers The following products have been recalled as of July 18: ITECH 361's All Clean Hand Sanitizer, Moisturizer and Disinfectant : UPC code 628055370130. 74530-015-02 FDA encourages health ce professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAs MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product): [7-2-2020] FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer productsthat are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Hideout Hand Sanitizer non-sterile solution Alcohol Antiseptic 80% Topical Solution. The Colorado-based company issued a voluntary recall of 20 lots of Adam's Polishes Hand Sanitizer to the consumer level in "an abundance of caution" after the FDA found one lot had contained. 79279-620-03 74721-0002-5 Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. Notice to manufacturers and distributors: If you believe your products are no longer within the labeled expiry period, are no longer in distribution, or you otherwise have information that your products no longer warrant inclusion on this list, you should provide your reasoning and supporting information for FDAs consideration [email protected]. FDA Recalls 149 Hand Sanitizers Due to "Toxic" Methanol - Hand 75821-002-02 Hand sanitizers recalled due to presence of cancer-causing - silive