Alcoholada Gel recall
FDA recall D-0459-2024 · initiated Mar 23, 2024
Aruba Aloe Balm N.V. recalled Alcoholada Gel in Mar 2024 — an FDA Class I recall (D-0459-2024) because Chemical Contamination: Product manufactured with ethanol API that contains methanol.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 9,625 bottles
Details
- 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 Caribbean.
- Recalling company
- Aruba Aloe Balm N.V.
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Mar 23, 2024
- FDA report date
- May 1, 2024
Frequently asked
- Was Alcoholada Gel recalled?
- Aruba Aloe Balm N.V. recalled Alcoholada Gel in Mar 2024 — an FDA Class I recall (D-0459-2024) because Chemical Contamination: Product manufactured with ethanol API that contains methanol. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Alcoholada Gel recalled?
- Per the FDA enforcement record, the reason for recall D-0459-2024 was: Chemical Contamination: Product manufactured with ethanol API that contains methanol
- Is a recalled Alcoholada Gel dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Alcoholada Gel are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — 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/…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0459-2024.