The methanol hand sanitizer recalls of 2020 and 2021

From May 1 through June 30, 2020, poison centers and hospitals in Arizona and New Mexico identified 15 people with methanol poisoning after they swallowed alcohol-based hand sanitizer. All were admitted to a hospital. Four died, and three left with impaired vision, according to a CDC report in Morbidity and Mortality Weekly Report¹. One patient, a 44-year-old man, was discharged after six days "with near-total vision loss."

Hand sanitizer is supposed to be made with ethanol or isopropyl alcohol. Methanol, also called wood alcohol, is cheaper and toxic. By July 15, 2020, FDA had tested and identified 67 hand sanitizer products containing it, the same CDC report noted. The agency's public list of sanitizers consumers should not use eventually grew to 665 product entries from more than 170 manufacturers, by GxRadar's count of FDA's final table².

It became a case study in what happens when demand for a simple over-the-counter drug spikes overnight and new suppliers rush in. It also produced FDA's first countrywide import alert for a whole category of drug, and testing rules that outlasted the pandemic.

A shortage, then a flood

Early in the COVID-19 pandemic, FDA loosened its rules to get more sanitizer on shelves. In March 2020 it issued three temporary guidance documents letting new firms make sanitizer and the alcohol that goes into it, according to the Federal Register notice⁵ that later withdrew them. Many of the new products were imported.

Problems surfaced within months. On July 2, 2020, FDA said it had 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," according to its hand sanitizer update page². The agency said it knew of adults and children who had swallowed contaminated products, with outcomes including blindness, hospitalization and death. It listed the effects of substantial methanol exposure as "nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death," and said young children who swallow sanitizer by accident and people who drink it as a substitute for alcohol were most at risk.

By July 31, FDA had widened its list to include subpotent sanitizers, with too little ethanol or isopropyl alcohol to work as labeled.

The first countrywide import alert for a drug category

On Jan. 26, 2021, FDA placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert, meaning shipments could be detained at the border unless the importer showed the product met US manufacturing rules. The agency said in its announcement³ that this "marks the first time the FDA has issued a countrywide import alert for any category of drug product."

FDA's own sampling explained the step. Of sanitizers from Mexico that the agency analyzed from April through December 2020, 84 percent were not in compliance with FDA regulations, and "more than half of the samples were found to contain toxic ingredients, including methanol and/or 1-propanol, at dangerous levels," the release³ said. It added that methanol usually did not appear on the label at all, and that FDA had issued 14 warning letters since July 2020 to firms distributing sanitizer with undeclared methanol, wrong ethanol content, misleading claims or poor manufacturing practices.

GxRadar's analysis of FDA's final do-not-use table points the same way. Of the 202 entries that mention methanol, either as a test finding or because a product came from a plant tied to contaminated product, 157 trace to manufacturers in Mexico.

What FDA's list shows

FDA no longer maintains its do-not-use list²; the page says it "is no longer being updated" and points readers to the recall database. GxRadar parsed the table as it stands, grouping entries by the date each was added.

Methanol was overwhelmingly a 2020 problem. Of the 202 methanol entries, 164, or 81 percent, were added that year. Later additions mostly had other causes, including 22 entries citing benzene and many entries for plants that did not answer FDA's requests for records, which FDA treated as grounds for an import alert. Of the 665 entries, 552 mention an import alert.

What the recall records show

By FDA's own notes, some listed products were never found on the US market and others were stopped at the border, so recall records capture only part of the problem. GxRadar searched FDA's openFDA enforcement database⁷ for sanitizer recalls whose reason cites methanol and found 89 records from 31 recall events. Fifty were Class I, the category FDA uses when there is a reasonable probability that a product will cause serious harm or death. Recalls clustered in two waves, July 2020 (27 records initiated) and April 2021 (19).

That Class I share, 56 percent, is far higher than for drugs in general. Across all 18,075 FDA drug recall records from 2012 through October 2026 tracked on GxRadar's recalls page, 1,753, or about 10 percent, were Class I; our analysis of Class I records breaks that down. Some 2021 recall notices listed methanol alongside benzene and acetaldehyde.

The rules that stayed

Pandemic-era manufacturing flexibility ended on a schedule. FDA withdrew all three March 2020 guidances effective Dec. 31, 2021, and gave firms until March 31, 2022, to stop distributing sanitizer made under them, according to the withdrawal notice⁵, which said consumers and health care workers were "no longer experiencing difficulties accessing" the products.

Testing requirements went the other way. In a guidance announced in the Federal Register in February 2021⁴, FDA told drug manufacturers and compounding pharmacists to run an identity test including a methanol limit test "on each container within each shipment of each lot" of ethanol or isopropyl alcohol before use, and to know who is in their supply chain. FDA's update page² added that alcohol containing more than 630 parts per million of methanol "may be considered evidence of substitution and/or contamination." In October 2023 the agency issued an updated final version that dropped the pandemic framing, explaining in the notice⁶ that "other drug products containing pharmaceutical alcohol" could be "similarly vulnerable to methanol contamination."

Substitution of a cheaper chemical for the real ingredient has happened before, most notoriously in the 2008 heparin contamination. Our piece on where drug ingredients come from covers how ingredient supply chains are checked. Readers holding an old bottle can search the brand or NDC on FDA's list, and GxRadar's guide to disposing of unused medicines covers what to do with products that should not be used.