FDA Notice: Hand Sanitizer Recalled Amid Warnings It Could Cause Comas or Blindness

A company is recalling hand sanitizer and aloe gel across the United States because it contains a highly poisonous substance that can pose a serious risk for consumers, according to a notice published on the U.S. Food and Drug Administration’s (FDA) website.

The recall affects 40 lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80 percent and Aruba Aloe Alcoholada Gel because they contain substantial amounts of methanol, the FDA-backed notice said.

It offered a risk statement saying that “substantial methanol exposure” can lead to a range of serious health issues such as death, coma, seizures, permanent blindness, permanent nervous system damage, blurred vision, vomiting, nausea, and other symptoms.

“All persons using these products on their hands are at risk,” said the notice, but it especially issued caution for “young children who accidently ingest these products and adolescents, and adults who drink these products as an alcohol (ethanol) substitute are most at risk for methanol poisoning.”

The company said it has has not received any reports of adverse events in connection to the products.

The firm did not say in the notice how its products were contaminated with methanol or how the error was found. Methanol, known as wood alcohol, is described by federal officials as “extremely poisonous” and that as little as two tablespoons “can be deadly to a child,” according to the MedcinePlus website.

“Blindness is common and often permanent despite medical care. Intake of methanol affects multiple organs,” the site says. “Organ damage may be permanent. How well the person does depends on how much poison is swallowed and how soon treatment is received.”

According to the notice, Aruba Aloe Hand Sanitizer Gel is used as a hand sanitizer and is packaged in a 12-ounce dark green bottle with a white label that reads, in part, “ARUBA ALOE Hand Sanitizer GEL 80% Alcohol Made in Aruba World’s Finest Aloe.”  The other product being recalled, Aruba Aloe Alcoholada Gel, is used for temporary relief of pain and itching. It’s packaged in a 2.2-ounce plastic bottle that are transparent with a label that reads, in part, “Alcoholada Gel Pain Relieving Gel 0.5% Lidocaine Hydrochloride.”

Lot numbers, bar codes, and other information for the two products can be found inside the recall notice. The products were distributed across the United States between May 1, 2021, and Oct. 27, 2023. They were sold online via the company’s website.

The firm said that it has notified all customers who purchased the products via email and offered a discount, while consumers who still have the recalled products are advised to discard them.

“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” the notice added. “Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.”

Other Recalls

It comes as Procter & Gamble announced it is recalling more than 8 million bags of Tide, Gain, Ace, and Ariel laundry detergent packets sold in the United States and Canada due to a defect in the products’ child-resistant packaging.

According to Friday notices from both P&G and product-safety regulators in the United States and Canada, the outer packaging meant to prevent easy access to the liquid laundry detergent pods can split open near the zipper track, posing serious risks to children and others who may ingest them, in addition to possible skin or eye injuries. So far, there have been no confirmed injuries directly tied to the defect.

During the time period that the recalled lots were sold, there were four reports of children accessing the laundry packets in the United States, including three ingestion cases, but whether these pods actually came from the recalled bags is still unknown, P&G and the U.S. Consumer Product Safety Commission said.

Separately, about 2 million Black & Decker-branded clothing steamers are now under recall after consumers reported dozens of burn injuries that resulted from hot water spewing out of the devices.

Empower Brands is significantly expanding a previously announced recall of Black & Decker Model HGS011 Easy Garment Steamers, according to a notice posted Thursday by the Consumer Product Safety Commission.

The Associated Press contributed to this report.
Related: Why Is This Carcinogen in Hand Sanitizers?

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