Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Recalled by Tenn South Distillery LLC dba Big Machine Distillery Due to CGMP Deviation: impurities exceed allowable limits.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tenn South Distillery LLC dba Big Machine Distillery directly.
Affected Products
Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL UPC 8 59105 00452 5; b) 100 mL UPC 8 59105 00453 2; c) 375 mL; d) 1/2 gallon; e) 1 gallon; f) 5 gallon; g) 55 gallon; i) Indianapolis Motor Speedway 50 mL UPC 8 59105 00452 5; j) Indianapolis Motor Speedway 375 mL UPC 8 59105 00454 9; k) Indianapolis Motor Speedway 1 gallon UPC 8 59105 00451 7; l) The Contributor 50 mL; m) Tony Kanaan Last Lap 100 mL; n) Tony Kanaan Last Lap 375 mL; o) Trexis Insurance 50 mL; p) Team Penske 50 mL; q) Middle Tennessee State University Lightning 50 mL.
Quantity: 540 gallons
Why Was This Recalled?
CGMP Deviation: impurities exceed allowable limits.
Where Was This Sold?
This product was distributed to 1 state: TN
About Tenn South Distillery LLC dba Big Machine Distillery
Tenn South Distillery LLC dba Big Machine Distillery has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report