The Recall Desk
CriticalFDA (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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 Caribbe
Manufacturer
Aruba Aloe Balm N.V.
Category
Drug — Topical Pain Reliever
Hazard
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 →

Related recalls

Same manufacturer · Aruba Aloe Balm N.V.

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Same hazard · methanol

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