PlainRecalls
ModerateClass IIOngoing

FDA Drug recall · Reported July 19, 2023

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) T

CGMP Deviation: impurities exceed allowable limits.

Recall #
D-0915-2023
Affected scope
540 gallons
Initiated
July 10, 2023
Compiled from official public sources by the publisher.
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Tenn South Distillery LLC dba Big Machine Distillery recalled Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical… - a moderate-severity action.

Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical… was recalled by Tenn South Distillery LLC dba Big Machine Distillery in July 19, 2023. Reason: CGMP Deviation: impurities exceed allowable limits.. Check the official notice for the remedy. Verify recall #D-0915-2023 with the FDA Drug before acting.

The recall

Tenn South Distillery LLC dba Big Machine Distillery issued this moderate-severity FDA Drug recall-CGMP Deviation: impurities exceed allowable limits..

Moderate
severity level
Class II
classification
July 19, 2023
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0915-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,472 drugs & medications recalls on record

05001,0001,5002,000 2006201220152018202120242026 448
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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 for recall

CGMP Deviation: impurities exceed allowable limits.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number D-0915-2023
Date reported July 19, 2023
Date initiated July 10, 2023
Recalling firm Tenn South Distillery LLC dba Big Machine Distillery
Firm location Lynnville, TN
Affected scope 540 gallons
Distribution TN

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0915-2023) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Tenn South Distillery LLC dba Big Machine Distillery. Units affected: 540 gallons.
Why was this product recalled? ▼
CGMP Deviation: impurities exceed allowable limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 19, 2023. Severity: Moderate. Recall number: D-0915-2023.
Where was the recalled product distributed? ▼
Distribution: TN.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Similar Drugs & Medications · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported July 19, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026