ethanol FDA Alerts
The FDA Alert(s) below may be specifically about ethanol or relate to a group or class of drugs which include ethanol.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for ethanol
95% Ethyl Alcohol Product by Ethanol Extraction: Recall - Due to a Possible Contamination with Methanol
May 23, 2018
ISSUE: Lake Michigan Distilling Company, LLC of La Porte, Indiana, doing business as Ethanol Extraction, is recalling its 95% Ethyl Alcohol product (“Product”) because of possible contamination with methanol, a highly toxic type of alcohol that can cause serious and sometimes fatal damage if ingested by humans or animals. Recall of the Product was sparked by news that a man in Massachusetts allegedly ingested the Product and later died as a result. There have been no other reports of any ingestion or injury since the Product was first marketed in October 2016.
BACKGROUND: The Product’s intended use is as a solvent for extracting essential oils from plant material, and contains warnings including “HARMFUL IF SWALLOWED. MAY CAUSE DAMAGE TO ORGANS.” The Product is not for human or animal consumption.
RECOMMENDATION: Consumers should not drink or otherwise ingest the Product. Any consumer who has already consumed the product should seek medical treatment immediately.
The company has ceased production and distribution of the Product as the FDA and the company continue their investigation as to what caused the problem. All bottles and containers of the Product are being recalled.
Consumers who have purchased Ethanol Extraction’s Product are urged to contact the company immediately to make arrangements for return shipment of the Product. Contact Dennis Zeedyk at Lake Michigan Distilling Company, LLC, 3522 SR104, LaPorte, Indiana 46350, Phone (219) 369‐1066, Fax (419) 715‐5070 between the hours of 9:00 a.m. and 3:30 p.m. EST.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[05/22/2018 - Recall Notice - FDA]