FDA Recall D-0460-2024

Aruba Aloe Balm N.V. · Oranjestad, N/A

Class I — life-threatening Ongoing 782 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5

Lot / code: Lot #: 25160, Exp 4/16/2024; 25344, Exp 5/20/2024, 25580, Exp 6/15/2024; 25828, Exp 7/28/2024; 26057, Exp 8/25/2024; 26195, Exp 9/18/2024; 26471, Exp 11/25/2024; 26754, Exp 1/20/2025; 26821, Exp 2/2/2025; 27005, Exp 3/11/2025; 27518, Exp 6/22/2025; 27927, Exp 8/26/2025; 28176, Exp 10/22/2025; 28392, Exp 12/31/2025.

Quantity: 5299 bottles

Reason for recall

Chemical Contamination: Product manufactured with ethanol API that contains methanol

Recall record

Recall number: D-0460-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the USA
Recall initiated: 2024-03-23
Classified by FDA Center: 2024-04-23
FDA published: 2024-05-01
Recalling firm: Aruba Aloe Balm N.V.
Firm location: Oranjestad, N/A, Aruba

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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