Hand Sanitizer, Aloe Gel Under Class I Recall

More than 40 lots of Aruba Aloe Hand Sanitizer Gel and Aruba Aloe Alcoholada Gel are under a Class I recall because they have been found to contain alcohol denatured with methanol. The recall is included in the May 1, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The FDA’s most significant recall category, a Class I designation warns use of the affected products could cause serious adverse health consequences or death.

“Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, coma, seizures, permanent blindness, permanent damage to the central nervous system, or death,” recalling firm Aruba Aloe Balm NV announced in an April 5, 2024, statement. “Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk for methanol poisoning.”

The recall affects the following products, which were manufactured in Aruba by Aruba Aloe Balm Inc. and distributed throughout the United States:

• Aruba Aloe Hand Sanitizer Gel, 80% alcohol, in 12-fluid-ounce (355-mL) plastic bottles (UPC 0 82252 03300 5), from lots 25160 (Exp. 4/16/24), 25344 (Exp. 5/20/24), 25580 (Exp. 6/15/24), 25828 (Exp. 7/28/24), 26057 (Exp. 8/25/24), 26195 (Exp. 9/18/24), 26471 (Exp. 11/25/24), 26754 (Exp. 1/20/25), 26821 (Exp. 2/2/25), 27005 (Exp. 3/11/25), 27518 (Exp. 6/22/25), 27927 (Exp. 8/26/25), 28176 (Exp. 10/22/25), and 28392 (Exp. 12/31/25); 
• Aruba Aloe Alcoholada Gel, 0.5% lidocaine hydrochloride, in 8.5-fluid-ounce (251-mL) plastic bottles (UPC 0 82252 03120 9), from lots 25253 (Exp. 5/1/24), 25976 (Exp. 8/11/24), 26150 (Exp. 9/11/24), 26473 (Exp. 11/25/24), 26553 (Exp. 12/11/24), 27318 (Exp. 5/10/25), 27481 (Exp. 6/15/25), 27660 (Exp. 7/15/25), 27839 (Exp. 8/5/25), 28121 (Exp. 10/7/25), 28152 (Exp. 10/18/25), 28355 (Exp. 12/17/25), 28761 (Exp. 2/22/26), 29088 (Exp. 4/1/26), 29510 (Exp. 5/11/26), 29558 (Exp. 5/13/26), 29728 (Exp. 6/3/26), 30339 (Exp. 9/13/26), and 30563 (Exp. 10/27/26); and 
• Aruba Aloe Alcoholada Gel, 0.5% lidocaine hydrochloride, in 2.2-fluid-ounce (65-mL) plastic bottles (UPC 0 82252 34030 1), from lots 25253 (Exp. 5/1/24), 25976 (Exp. 8/11/24), 26150 (Exp. 9/11/24), 26553 (Exp. 12/11/24), 26696 (Exp. 1/8/25), 27318 (Exp. 5/10/25), 27481 (Exp. 6/15/25), 27660 (Exp. 7/15/25), 27839 (Exp. 8/5/25), 28281 (Exp. 11/30/25), 28355 (Exp. 12/17/25), 28761 (Exp. 2/22/26), 29088 (Exp. 4/1/26), 29728 (Exp. 6/3/26), 30086 (Exp. 7/26/26), 30339 (Exp. 9/13/26), and 30563 (Exp. 10/27/26).

Aruba Aloe Balm NV voluntarily initiated the recalls March 23, 2024. The FDA designated them Class I on April 23, 2024.

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

As of April 5, 2024, Aruba Aloe Balm NV had not received any reports of adverse events related to the recalled products, according to the company.