FDA Recall of Hand Sanitizer and Burn Gel

In cooperation with the FDA, Aruba Aloe Balm N.V. has issued a recall of their hand sanitizer gel and alcoholada gel due to the presence of methanol. The Aruba-based company distributes its products online via its website, www.arubaaloe.com. Denatured methanol is contained in hand sanitizer products and may cause serious harm to those exposed, especially if the substance is ingested.

As of this notice, the FDA has not announced any information about adverse events related to this recall. However, consumers should take the recall very seriously and follow the recall procedures included at the bottom of this page.  

SUMMARY

Date of Recall:

Announced: April 5, 2024

Public Notification: April 5, 2024

Name(s) of Drug:

Aruba Aloe Hand Sanitizer GEL

Aruba Aloe Alcoholada Gel

Company Name:

Aruba Aloe Balm N.V.

Drug Indication:

Hand Sanitizer

Skin Irritations/Burns

Product Description

Aruba Aloe Hand Sanitizer Gel is marketed as an antibacterial gel. It is packaged in dark green plastic bottles labeled “Aruba Aloe Hand Sanitizer Gel, 80%.” The bottles are 12 fluid ounces and were distributed nationwide via www.arubaaloe.com from 5/1/2021 to 10/27/2023.

Aruba Aloe Alcoholada Gel is marketed as a treatment for sunburns and other minor skin irritations, such as insect bites. It is packaged in transparent bottles, each labeled as “Alcoholada Gel Pain Relieving Gel, 0.5%.” This product was sold in 2.2 fluid-ounce bottles, 1 fluid-ounce bottle, and 8.5 fluid-ounce bottles. Each product was distributed nationwide via www.arubaaloe.com between 5/1/2021 and 10/27/2023.

Reason for Recall

Exposure to Methanol through topical (skin), inhalation (breathing in fumes), or consumption (drinking the fluid) may lead to adverse health outcomes such as:

• Nausea
• Vomiting
• Headache
• Dermatitis
• Blurred vision
• Loss of Appetite
• Abdominal Pain
• Gastrointestinal Bleeding
• Diarrhea
• Pancreatitis
• Giddiness
• Insomnia
• Mania
• Amnesia
• Visual Hallucinations
• Tachycardia (fast heart rate)
• Bradycardia (slow heart rate)
• Hypotension (low blood pressure)
• Tachypnea (fast breathing)
• Respiratory Arrest (no longer breathing)
• Seizures
• Blindness
• Permanent damage to the central nervous system
• Coma
• Death

Impacts

As listed previously, consumers who have been exposed to or consumed the contaminated hand sanitizer may experience serious health outcomes. Any exposures must be reported to your physician, and anyone having ingested the substance must receive immediate medical attention.  

Lot Information

Consumers who have any of the listed products in their possession should compare the information on their bottle to the information listed below. If your product details match those listed below, read further for instructions on complying with recall procedures.

FDA.gov

Have you found that your product is part of the drug recall? Here’s what you should do:

Consumers

1. If you believe you have been exposed to contaminated products, immediately notify your physician and request medical assistance.
2. Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
3. Consumers with questions may contact Aruba Aloe Balm N.V. by email at recall@arubaaloe.com
4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Aruba Aloe Balm N.V. by email at recall@arubaaloe.com. Notify them of any recalled batches that have already been sold to consumers.
3. Notify affected consumers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Aruba Aloe Balm N.V. by email at recall@arubaaloe.com. Notify them of any recalled batches that have already been shipped to retailers.
3. Notify affected retailers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!