FDA Drug recall D-0915-2023

Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine…

• FDA Drug
• Class II
• ongoing
• Published 2023-07-19

On 2023-07-19 the FDA classified a Class II recall of Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine… by Tenn South Distillery, citing CGMP Deviation: impurities exceed allowable limits.

Read the official FDA Drug notice

Product

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.

Reason

CGMP Deviation: impurities exceed allowable limits.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0915-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.