FDA MedWatch – Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel by Aruba Aloe Balm N.V.

TOPIC: Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel by Aruba Aloe Balm N.V.: Recall: Due to Presence of Methanol

AUDIENCE: Consumer, Health Professional, Pharmacy, Dermatology

ISSUE: Aruba Aloe Balm N.V. is recalling 40 lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel because the products have been found to contain alcohol denatured with methanol.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache blurred vision, coma, seizures, permanent blindness, permanent damage to the central nervous system, or death. Although all persons using these products on their hands are at risk, 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.

Products were distributed between 5/1/2021 and 10/27/2023 and sold in the US online only via the Aruba Aloe Balm N.V. website.

To date, Aruba Aloe Balm N.V. has not received any reports of adverse events related to these products.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND:

• Aruba Aloe Hand Sanitizer Gel is used as a sanitizer to help reduce bacteria that potentially can cause disease.

• Aruba Aloe Alcoholada Gel is used for temporary relief of pain and itching associated with minor burns, sunburn, insect bites, or minor skin irritations.

RECOMMENDATIONS: 

• 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.

• Consumers that have products which are being recalled should stop using and discard the product.

• Consumers with questions regarding this recall can contact Aruba Aloe Balm N.V. by Email: recall@arubaaloe.com.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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