CLASS I ONGOING Drug recall · Reported 1 May 2024 · FDA Enforcement Report
Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride recalled
Aruba Aloe Balm N.V is recalling Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, distributed nationwide in the US. The recall was initiated on 23 Mar 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0459-2024
- FDA event ID
- 94335
- Recalling firm
- Aruba Aloe Balm N.V, Oranjestad, N/A
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 23 Mar 2024
- FDA classified
- 23 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Drug class
- Pain Medication
Timeline
| 23 Mar 2024 | Recall initiated by company | |
| 23 Apr 2024 | Classified by FDA | +31 days |
| 1 May 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Which lots are affected?
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.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94335| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Aruba Aloe Hand Sanitizer Gel, 80% Alcohol recalled | Aruba Aloe Balm N.V | Foreign Material | Nationwide |
More recalls from Aruba Aloe Balm N.V
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Aruba Aloe Hand Sanitizer Gel, 80% Alcohol recalled | Aruba Aloe Balm N.V | Foreign Material | Nationwide |