Agency classClass IOur severity:Critical FDA (Drugs)·D-0459-2024·Announced 2024-05-01

FDA Recalls Alcoholada Gel Pain Reliever Over Methanol Contamination

Alcoholada Gel pain reliever is being recalled because the ethanol ingredient contains methanol contamination. The FDA classified this as a Class I recall affecting 9,625 bottles distributed nationwide.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This product carries an FDA Class I classification, which per the severity rubric represents the highest level of regulatory concern. FDA Class I is explicitly cited as a criterion for a Critical severity score.

Plain-English summary

Alcoholada Gel, a topical pain relieving gel containing 0.5% Lidocaine Hydrochloride, is being recalled by the FDA due to chemical contamination in the product's active ingredient.

The product was manufactured with ethanol that contains methanol contamination. Methanol is a toxic substance that can cause serious harm if absorbed through the skin or ingested accidentally.

The recall affects 9,625 bottles sold nationwide in the United States. Both bottle sizes are affected: the 8.5 fl oz (251 mL) bottles and the 2.2 fl oz (65 mL) bottles. Multiple lot numbers are involved, with expiration dates ranging from May 2024 through October 2026.

Consumers who have purchased Alcoholada Gel should stop using the product immediately and dispose of it safely. Anyone with questions or concerns should contact their pharmacist or healthcare provider.

The recalled product

Product: 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…
Manufacturer: Aruba Aloe Balm N.V.
Category: Drug — Topical Pain Reliever
Hazard: methanol
chemical-contamination
Affected units: 9,625

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Aruba Aloe Balm N.V. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Aruba Aloe Balm N.V.

See all →

Severe
FDA Recalls Aruba Aloe Hand Sanitizer for Methanol Contamination
FDA (Drugs) · 2024-05-01

Same hazard · methanol