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.- Is made at a facility that did not respond to multiple FDA requests for information about the quality of their products and manufacturing process.
FDA advises consumers not to use hand sanitizers produced by the manufacturers identified 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.
Manufacturer Product(s) NDC(s) Distributor Product Status Date
4E Global SAPI de CV (Mexico) Blumen Clear Advanced Hand Sanitizer with 70% Alcohol with Glycerin and Aloe 60599-018-0060599-018-0260599-018-04 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 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 Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E 60599-015-0160599-015-02 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 60599-012-0460599-012-08 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 60599-012-0060599-012-0160599-012-0260599-012-0360599-012-0560599-012-0660599-012-0760599-012-10 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 60599-013-0060599-013-0160599-014-00 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 60599-018-0260599-018-0460599-018-0660599-018-07
4E Brands North America LLC
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 FDA’s consideration to [email protected]. FDA will consider revising the list as appropriate.
Hand Sanitizer Warning: FDA updates list consumers should NOT use – Bachelor on the Cheap
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.- Is made at a facility that did not respond to multiple FDA requests for information about the quality of their products and manufacturing process.
FDA advises consumers not to use hand sanitizers produced by the manufacturers identified 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.
Manufacturer Product(s) NDC(s) Distributor Product Status Date
4E Global SAPI de CV (Mexico) Blumen Clear Advanced Hand Sanitizer with 70% Alcohol with Glycerin and Aloe 60599-018-0060599-018-0260599-018-04 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 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 Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E 60599-015-0160599-015-02 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 60599-012-0460599-012-08 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 60599-012-0060599-012-0160599-012-0260599-012-0360599-012-0560599-012-0660599-012-0760599-012-10 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 60599-013-0060599-013-0160599-014-00 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 60599-018-0260599-018-0460599-018-0660599-018-07
4E Brands North America LLC
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 FDA’s consideration to [email protected]. FDA will consider revising the list as appropriate.