Aruba Aloe Hand Sanitizer Gel and Alcoholada Gel recall: Product contains methanol

What the company announced

FOR IMMEDIATE RELEASE – April 5th, 2024 – Oranjestad, Aruba, Aruba Aloe Balm N.V. is voluntarily recalling 40 lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel to the consumer level. 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. To date, Aruba Aloe Balm N.V. has not received any reports of adverse events related to these products.

Aruba Aloe Hand Sanitizer Gel is used as a sanitizer to help reduce bacteria that potentially can cause disease and is packaged in 12 fl oz (355 mL) dark green plastic bottles with white label reading in part “ARUBA ALOE Hand Sanitizer GEL 80% Alcohol Made in Aruba World’s Finest Aloe”, with barcode 0 82252 03300 5. Lot numbers being recalled are listed in the below table.

Aruba Aloe Alcoholada Gel is used for temporary relief of pain and itching associated with minor burns, sunburn, insect bites, or minor skin irritations and is packaged in two sizes: 2.2 fl oz (65 mL) plastic bottles with barcode 0 82252 34030 1 and 8.5 fl oz (251 mL) plastic bottles with barcode 0 82252 03120 9. The plastic bottles are transparent with a label reading in part “Alcoholada Gel Pain Relieving Gel 0.5% Lidocaine Hydrochloride”. Lot numbers being recalled are listed in the below table.

The affected Aruba Aloe Hand Sanitizer GEL product lots (filled in 12 fl. oz bottles) include the following:

• Lot Number: 25344 · Expiration date: 5/20/2024
• Lot Number: 25828 · Expiration date: 7/28/2024
• Lot Number: 26057 · Expiration date: 8/25/2024
• Lot Number: 26471 · Expiration date: 11/25/2024
• Lot Number: 26754 · Expiration date: 1/20/2025
• Lot Number: 26821 · Expiration date: 2/2/2025
• Lot Number: 27518 · Expiration date: 6/22/2025
• Lot Number: 28392 · Expiration date: 12/31/2025
• Lot Number: 24759 · Expiration date: 3/4/2024
• Lot Number: 25160 · Expiration date: 4/16/2024
• Lot Number: 25580 · Expiration date: 6/15/2024
• Lot Number: 26195 · Expiration date: 9/18/2024
• Lot Number: 27005 · Expiration date: 3/11/2025
• Lot Number: 27927 · Expiration date: 8/26/2025
• Lot Number: 28176 · Expiration date: 10/22/2025

The affected Aruba Aloe Alcoholada Gel product lots (filled in 2.2 and 8.5 fl. oz bottles) include the following:

• Lot Number: 25253 · 8.5 oz: X · 2.2 oz: X · Expiration date: 5/1/2024
• Lot Number: 25976 · 8.5 oz: X · 2.2 oz: X · Expiration date: 8/11/2024
• Lot Number: 26150 · 8.5 oz: X · 2.2 oz: X · Expiration date: 9/11/2024
• Lot Number: 26473 · 8.5 oz: X · Expiration date: 11/25/2024
• Lot Number: 26553 · 8.5 oz: X · 2.2 oz: X · Expiration date: 12/11/2024
• Lot Number: 26696 · 2.2 oz: X · Expiration date: 1/8/2025
• Lot Number: 27318 · 8.5 oz: X · 2.2 oz: X · Expiration date: 5/10/2025
• Lot Number: 27481 · 8.5 oz: X · 2.2 oz: X · Expiration date: 6/15/2025
• Lot Number: 27660 · 8.5 oz: X · 2.2 oz: X · Expiration date: 7/15/2025
• Lot Number: 27839 · 8.5 oz: X · 2.2 oz: X · Expiration date: 8/5/2025
• Lot Number: 28121 · 8.5 oz: X · Expiration date: 10/7/2025
• Lot Number: 28152 · 8.5 oz: X · Expiration date: 10/18/2025
• Lot Number: 28281 · 2.2 oz: X · Expiration date: 11/30/2025
• Lot Number: 28355 · 8.5 oz: X · 2.2 oz: X · Expiration date: 12/17/2025
• Lot Number: 28761 · 8.5 oz: X · 2.2 oz: X · Expiration date: 2/22/2026
• Lot Number: 29088 · 8.5 oz: X · 2.2 oz: X · Expiration date: 4/1/2026
• Lot Number: 29510 · 8.5 oz: X · Expiration date: 5/11/2026
• Lot Number: 29558 · 8.5 oz: X · Expiration date: 5/13/2026
• Lot Number: 29728 · 8.5 oz: X · 2.2 oz: X · Expiration date: 6/3/2026
• Lot Number: 30086 · 2.2 oz: X · Expiration date: 7/26/2026
• Lot Number: 30339 · 8.5 oz: X · 2.2 oz: X · Expiration date: 9/13/2026
• Lot Number: 30563 · 8.5 oz: X · 2.2 oz: X · Expiration date: 10/27/2026

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.

Aruba Aloe Balm N.V. has notified all customers that bought these products by email and has offered a discount coupon for a next purchase.

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: [email protected] . 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.

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.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.