Medications & Supplements/Topical Products

Big Machine Distillery Hand Sanitizer Recalled for High Impurity Levels

Agency Publication Date: July 12, 2023

Summary

Tenn South Distillery LLC, doing business as Big Machine Distillery, has recalled 540 gallons of Big Machine Distillery Hand Sanitizer Non-Sterile Alcohol Antiseptic 80% Topical Solution. The recall includes various sizes such as 50 mL, 100 mL, 375 mL, 1/2 gallon, 1 gallon, 5 gallon, and 55 gallon containers, as well as special editions for the Indianapolis Motor Speedway and Team Penske. This action was taken because the product contains impurities that exceed allowable safety limits due to manufacturing deviations.

Risk

The product was found to have levels of impurities that exceed government safety standards, which may pose a health risk when applied to the skin or if accidentally ingested. No injuries or adverse events have been reported to date.

What You Should Do

This recall affects Big Machine Distillery Hand Sanitizer Non-Sterile Alcohol Antiseptic 80% Topical Solution in sizes ranging from 50 mL to 55 gallon drums, including branded editions for Indianapolis Motor Speedway, Team Penske, and Middle Tennessee State University.
Identify the product by checking the brand name and UPC codes on the packaging. Affected UPCs include 859105004525 (50 mL), 859105004532 (100 mL), 859105004549 (375 mL), and 859105004517 (1 gallon). All lots that are currently within their expiration dates are included in this recall.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Big Machine Distillery directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution

Variants: 50 mL, 100 mL, 375 mL, 1/2 gallon, 1 gallon, 5 gallon, 55 gallon, Indianapolis Motor Speedway edition, The Contributor edition, Tony Kanaan Last Lap edition, Trexis Insurance edition, Team Penske edition, Middle Tennessee State University Lightning edition

UPC Codes:

859105004525

859105004532

859105004549

859105004517

Lot Numbers:

All lots remaining within expiry

Produced and Distributed by Big Machine Distillery at 1800 Abernathy Road, Lynnville, TN 38472.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92634

Status: Active

Manufacturer: Tenn South Distillery LLC dba Big Machine Distillery

Sold By: Indianapolis Motor Speedway; The Contributor; Trexis Insurance; Team Penske; Middle Tennessee State University

Manufactured In: United States

Units Affected: 540 gallons

Distributed To: Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Big Machine Distillery Hand Sanitizer Non-Sterile Alcohol Antiseptic 80% Topical Solution in sizes ranging from 50 mL to 55 gallon drums, including branded editions for Indianapolis Motor Speedway, Team Penske, and Middle Tennessee State University.

Identify the product by checking the brand name and UPC codes on the packaging. Affected UPCs include 859105004525 (50 mL), 859105004532 (100 mL), 859105004549 (375 mL), and 859105004517 (1 gallon). All lots that are currently within their expiration dates are included in this recall.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Big Machine Distillery directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution

UPC Codes:

859105004525

859105004532

859105004549

859105004517

Lot Numbers:

All lots remaining within expiry

Produced and Distributed by Big Machine Distillery at 1800 Abernathy Road, Lynnville, TN 38472.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92634

Status: Active

Manufacturer: Tenn South Distillery LLC dba Big Machine Distillery

Sold By: Indianapolis Motor Speedway; The Contributor; Trexis Insurance; Team Penske; Middle Tennessee State University

Manufactured In: United States

Units Affected: 540 gallons

Distributed To: Tennessee