---
title: "Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic... — FDA record D-0915-2023 | Is It on Recall"
description: "CGMP Deviation: impurities exceed allowable limits."
url: https://isitonrecall.com/recall/fda-drug-d-0915-2023-big-machine-distillery-hand-sanitizer-non-sterile-solution-alcohol-antiseptic-80-topical-solution-pr/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Dist... — FDA record D-0915-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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.
- **Classification**: Class II
- **Recalling firm**: Tenn South Distillery LLC dba Big Machine Distillery
- **Quantity**: 540 gallons
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0915-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0915-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | All lots remaining within expiry. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

TN

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Tennessee](https://isitonrecall.com/state/tennessee/)

## Dates in the source

- **Report date**: Jul 19, 2023
- **Recall initiation date**: Jul 10, 2023
- **Center classification date**: Jul 12, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0915-2023%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Tenn South Distillery LLC dba Big Machine Distillery records](https://isitonrecall.com/brand/tenn-south-distillery-llc-dba-big-machine-distillery/)