On December 21, 2020, the FDA issued a warning letter to Broncolin, S.A. de C.V. because laboratory tests showed that their product HERBACIL Antiseptic Hand Sanitizer contains methanol, which is toxic when absorbed through the skin or ingested.

The FDA first warned consumers about the possible presence of methanol in certain hand sanitizers in June and has continued to update consumers about potentially-affected products and recalls.

Broncolin announced a recall of Herbacil Antiseptic Hand Sanitizer in July, but FDA tests showed the continued existence of methanol.

While the product labels state Herbacil Antiseptic Hand Sanitizer contains 70% ethanol, the tests found that the product actually contained an average of 4.7% ethanol and 66% of the potentially-harmful methanol. This product is adulterated because the label incorrectly states the ingredients, and it is also misbranded because it is "dangerous to health when used according to its labeling as a hand sanitizer."

Methanol, sometimes called wood alcohol, is poisonous. Methanol exposure through the skin or by ingestion can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. The agency warned that consumers who have been exposed to hand sanitizer containing methanol to "seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning."

The FDA warned that while all individuals are at risk of harmful events if they use this product, those most in danger of methanol poisoning are children who accidentally ingest the hand sanitizer and adults who drink it as a substitute for ethanol.

Methanol is a different form of alcohol than ethyl alcohol. Hand sanitizer containing at least 60% ethyl alcohol is recommended by the CDC for disinfecting hands when soap and water are not available, and is generally considered safe when used as directed. See the CDC's website for more information about using hand sanitizer.

For more information, use the link below.

Warning Letter: Broncolin, S.A. de C.V.

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