Drug & Device Safety Atlas
Class I FDA drug recall · D-0459-2024

Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.

Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean.

Why it was recalled

Chemical Contamination: Product manufactured with ethanol API that contains methanol

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information
Lot, expiry: (a) 25253, Exp 5/1/2024; 25976, Exp 8/11/2024; 26150, Exp 9/11/2024; 26473, Exp 11/25/2024; 26553, Exp 12/11/2024; 27318, Exp 5/10/2025; 27481, Exp 6/15/2025; 27660, Exp 7/15/2025; 27839, Exp 8/5/2025; 28121, Exp 10/7/2025; 28152, Exp 10/18/2025; 28355, Exp 12/17/2025; 28761, Exp 2/22/2026; 29088, Exp 4/1/2026; 29510, Exp 5/11/2026; 29558, Exp 5/13/2026; 29728, Exp 6/3/2026; 30339, Exp 9/13/2026; 30563, Exp 10/27/2026.  (b) 25253, Exp 5/1/2024; 25976, Exp 8/11/2024; 26150, Exp 9/11/2024; 26553, Exp 12/11/2024; 26696, Exp 1/8/2025; 27318, Exp 5/10/2025; 27481, Exp 6/15/2025; 27660, Exp 7/15/2025; 27839, Exp 8/5/2025; 28281, Exp 11/30/2025; 28355, Exp 12/17/2025; 28761, Exp 2/22/2026; 29088, Exp 4/1/2026; 29728, Exp 6/3/2026; 30086, Exp 7/26/2026; 30339, Exp 9/13/2026; 30563, Exp 10/27/2026.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Nationwide in the USA

Recall record

Recalling firm
Aruba Aloe Balm N.V.
Product type
Drugs
Recall number
D-0459-2024
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
E-Mail
Origin
Oranjestad, N/A
Recall initiated
2024-03-23

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall D-0459-2024 · Source: openFDA enforcement.