Recall: hand sanitiser pulled from US shelves over hidden methanol
A US distributor recalled a Mexican-made alcohol hand sanitiser after its own testing found methanol that was not on the label. Here is what was affected, why methanol is so dangerous, and the checks that stop it reaching a bottle.
By CSL Regulatory affairs team, Cosmetic Science Lab · Source: US FDA recall notice
Alert summary
- Authority
- US Food and Drug Administration (FDA)
- Announced
- 2 July 2020 (company and FDA)
- Recalling firm
- Transliquid Technologies LLC, USA (distributor)
- Manufacturer
- Mystic Intl S.A. de C.V., Mexico City
- Hazard
- Undeclared methanol (chemical, toxic)
- Measure
- Voluntary recall to retail level; now closed by FDA
01Affected products
| Product | Brand | Type | Pack | How to recognise it |
|---|---|---|---|---|
| Protection Topical Solution | Mystic Shield | Alcohol-based hand sanitiser | 250 ml (8.45 fl oz) bottle | Blue or green label, white or clear cap |
The product was sent to selected wholesale and retail customers in California, Louisiana, Massachusetts and Texas between 21 May and 30 June 2020. The notice did not list individual lot numbers, so the recall covered every bottle of this product.
02The issue
Testing commissioned by the US distributor found methanol in the sanitiser. Methanol (methyl alcohol) was not declared on the label and is not an acceptable active ingredient for hand sanitisers in the US. The product was sold to reduce bacteria on the hands when soap and water are not available, which makes it an over-the-counter (OTC) drug in the US rather than a cosmetic.
Methanol can be absorbed through the skin and is highly toxic if swallowed. Significant exposure can cause nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, lasting nerve damage or death. Young children who swallow sanitiser by accident, and anyone drinking it as an alcohol substitute, are most at risk.
At the time of the announcement the company said it had received no reports of adverse events linked to the product.
03What consumers should do
- Stop using the product straight away
- Return it to the place of purchase
- Seek medical help if you or a child has swallowed it or has symptoms after use
- Report any side effects to FDA’s MedWatch programme
04What brands and retailers should do
- Check stock and supplier lists for the recalled product and manufacturer
- Ask suppliers of alcohol-based products for batch certificates that include a methanol result
- Test incoming ethanol and isopropanol for methanol before use
- Keep supplier qualification and batch records ready for an FDA inspection
05Root cause and lessons
This recall was one of many during 2020, when demand for hand sanitiser surged and new suppliers entered the market quickly. Some products were made with alcohol contaminated with methanol, or with methanol used in place of ethanol. FDA went on to place alcohol-based hand sanitisers from Mexico on a countrywide import alert in January 2021, and published guidance asking manufacturers to test alcohol for methanol before using it.
“A certificate of analysis is only as good as the lab behind it. For any alcohol-based product we test the alcohol itself, batch by batch, before it goes near a mixing vessel.”
Cosmetic Science Lab regulatory affairs team
Three controls would have caught this: qualifying the alcohol supplier with an audit and a certificate of analysis, testing each incoming lot of ethanol or isopropanol for methanol by gas chromatography, and testing the finished batch before release. In the EU, hand sanitisers are regulated as biocides, and methanol is allowed in cosmetics only as a denaturant within a strict limit, so the same checks apply to any product sold there.
06Regulatory reference
- US FDA. Transliquid Technologies LLC issues voluntary recall of Mystic Shield Protection Topical Solution due to the presence of undeclared methanol. Company announcement, 2 July 2020. Read the FDA notice
- US FDA. Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol. FDA guidance
- US FDA MedWatch: side effects can be reported online, by post or by fax.
Update log
- Recall announced by the company and published by FDA
- FDA marked the recall completed and terminated
- This analysis published by Cosmetic Science Lab
This article summarises a public FDA notice and adds our own analysis. It is general information, not legal advice. Product names are used only to identify the recall.
