Need help now? Call 9-1-1 if the person is unconscious or has trouble breathing. Call Poison Help at 800-222-1222 to connect to your local poison center. Learn more at poisonhelp.hrsa.gov/.
Hand sanitizers consumers should not use
10/4/2021: UPDATE – FDA advises consumers not to use certain artnaturals hand sanitizers
[10/4/2021] FDA has tested certain artnaturals scent free hand sanitizer labeled with “DIST. by artnaturals Gardena, CA 90248” and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. The agency urges consumers not to use this contaminated product and has added artnaturals hand sanitizer products to the list of hand sanitizers consumers should not use.
To date, artnaturals has not responded to multiple FDA attempts to discuss the contaminated hand sanitizers, including identification of the manufacturer, possible recalls, and the scope of the contamination. Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers.
Benzene may cause certain types of cancer in humans. Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. Acetal can irritate the upper respiratory tract, eyes, and skin. While the exact risk from using hand sanitizer containing benzene, acetaldehyde, or acetal is unknown, FDA recommends consumers do not use products contaminated with unacceptable levels of benzene, acetaldehyde, or acetal.
Consumers who have products on this list of hand sanitizers should immediately stop using the product and dispose of it, ideally in a hazardous waste container. Do not pour these products down the drain or flush them. Contact your local waste management and recycling center for more information on hazardous waste disposal.
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. 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).
FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
3/25/2021: UPDATE – FDA warns consumers not to use Durisan Antimicrobial Solutions recalled Hand Sanitizer Alcohol-Free due to microbial contamination
1/26/2021: PRESS RELEASE – Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers
1/19/2021: UPDATE – FDA Provides Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During COVID-19 Public Health Emergency
8/27/2020 PRESS RELEASE – COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers
8/24/2020: UPDATE – FDA provides testing method to assess the quality of hand sanitizer products for impurities
8/12/2020: UPDATE – FDA expands hand sanitizer warnings to include 1-propanol contamination
8/7/2020: UPDATE – FDA Includes Methanol Testing in Temporary Policies for Alcohol-Based Hand Sanitizers
7/31/2020: UPDATE – FDA continues to find issues with certain hand sanitizer products
7/27/2020 PRESS RELEASE – Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products
7/2/2020: UPDATE – FDA warns consumers of risk of methanol contamination in certain hand sanitizers
[7-2-2020] FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.
The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death.
Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects. FDA’s investigation of methanol in certain hand sanitizers is ongoing. The agency will provide additional information as it becomes available.
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. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk.
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. 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).
FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. The agency is especially concerned with:
- The dangers of drinking any hand sanitizer under any conditions. While hand sanitizers with possible methanol contamination are more life-threatening than those that are not contaminated, FDA urges consumers not to drink any of these products.
- Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol.
- Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (e.g., for up to 24-hours).
- Products that are fraudulently marketed as “FDA-approved” since there are no hand sanitizers approved by FDA.
- 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. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child.
- Products labeled with harmful or poisonous ingredients, such as methanol.
FDA is aware of reports of adverse events associated with hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
7/2/2020 PRESS RELEASE – FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol
6/19/2020 ALERT – FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem
FDA urges consumers not use certain hand sanitizer products
The following chart outlines the information on hand sanitizer labels for consumers to use to identify a product that:
- Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal.
- Is labeled to contain methanol.
- Has been tested and is found to have microbial contamination.
- Is being recalled by the manufacturer or distributor.
- Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride.
- 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.
- Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion.
FDA advises consumers not to use hand sanitizers produced by the manufacturersidentified in the table below. Consumers can easily identify which hand sanitizer products to avoid by using the following information:
- The names of the specific manufacturers.
- NDC number, which may also be located on the product label.
- The name of the distributors that sell, or sold, or had planned to sell specific hand sanitizers products produced by these manufacturers.
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. Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. Consumers should be aware that FDA’s recommendation against using a distributor’s specific hand sanitizer product(s) manufactured by a particular manufacturer, as listed below, does not extend to:
- A distributor’s products bearing the same brand name as listed below, but made by a different manufacturer
- Other products distributed by the same distributor
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. If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product.
For more information, visit Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use?
| Manufacturer | Product(s) | NDC(s) | Distributor | Product Status | Date added to table |
|---|---|---|---|---|---|
| 4E Global SAPI de CV (Mexico) | Blumen Clear Advanced Hand Sanitizer with 70% Alcohol with Glycerin and Aloe | 60599-018-00 60599-018-02 60599-018-04 | 4E Brands North America LLC | FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E | 60599-015-00 | 4E Brands North America LLC | FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alertto help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E | 60599-015-01 60599-015-02 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/11/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | KLAR AND DANVER Instant Hand Sanitizer | 33992-8010-1 | Greenbrier International Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | MODESA Instant Hand Sanitizer Moisturizers and Vitamin E | 60599-007-33 | Midwood Brands LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Hand Sanitizer | 60599-012-04 60599-012-08 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Hand Sanitizer | 60599-012-00 60599-012-01 60599-012-02 60599-012-03 60599-012-05 60599-012-06 60599-012-07 60599-012-10 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Hand Sanitizer Aloe | 60599-013-00 60599-013-01 60599-014-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Instant Hand Sanitizer Lavender | 60599-016-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Clear Advanced Hand Sanitizer | 60599-018-02 60599-018-04 60599-018-06 60599-018-07 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
Showing 1 to 10 of 260 entries
Notice to manufacturers and distributors: If you believe your products do not meet the criteria for inclusion on this list, please provide your reasoning and supporting information for our consideration to [email protected].
- Content current as of:10/04/2021
- Regulated Product(s)
- Drugs
- Drug Safety and Availability
- Information about Nitrosamine Impurities in Medications
- Drug Alerts and Statements
- Medication Guides
- Drug Safety Communications
- Drug Shortages
- FDA Drug Safety Podcasts
- Information by Drug Class
- Medication Errors Related to CDER-Regulated Drug Products
- Postmarket Drug Safety Information for Patients and Providers
- Risk Evaluation and Mitigation Strategies | REMS
- Safe Use Initiative
- Drug Recalls
- Drug Supply Chain Integrity
- Multistate outbreak of fungal meningitis and other infections
