Medications & Supplements/Topical Products

Rock Town Distillery Hand Sanitizer Recalled for Acetal Contamination

Agency Publication Date: March 22, 2022

Summary

Rock Town Distillery, Inc. is recalling approximately 35,468 containers of Rock Town Distillery Hand Sanitizer (Alcohol Antiseptic 70%, Topical Solution). FDA analysis found the product contains acetal and acetaldehyde at levels above specification limits. The recall affects four different bottle sizes, ranging from 8 ounces to 1 gallon, which were distributed in Arkansas.

Risk

The presence of acetal and acetaldehyde above specification limits may cause skin irritation or other adverse health effects when applied to the hands. Acetaldehyde is also considered a potential human carcinogen.

What You Should Do

This recall affects Rock Town Distillery Hand Sanitizer (Alcohol Antiseptic 70%, Topical Solution) packaged in 375 mL (12.7 fl. oz.), 1 gallon, 236 mL (8 oz.), and 473 mL (16 oz.) bottles. The products do not list a lot number or expiration date on the packaging.
The affected products can be identified by the following NDC codes: 74492-0002-1, 74492-0002-2, 74492-0002-3, and 74492-0002-4.
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 the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Rock Town Distillery Hand Sanitizer (Alcohol Antiseptic 70%, Topical Solution)

Variants: 375 mL (12.7 fl. oz.), 3785 mL (1 gallon), 236 mL (8 oz.), 473 mL (16 oz.)

Lot Numbers:

No lot number or expiration date.

NDC:

74492-0002-1

74492-0002-2

74492-0002-3

74492-0002-4

Quantity: 35,468 containers. Made in USA.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89774

Status: Resolved

Manufacturer: Rock Town Distillery, Inc.

Sold By: Rock Town Distillery

Manufactured In: United States

Units Affected: 35,468 containers

Distributed To: Arkansas

Agency Last Updated: March 23, 2022

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 Rock Town Distillery Hand Sanitizer (Alcohol Antiseptic 70%, Topical Solution) packaged in 375 mL (12.7 fl. oz.), 1 gallon, 236 mL (8 oz.), and 473 mL (16 oz.) bottles. The products do not list a lot number or expiration date on the packaging.

The affected products can be identified by the following NDC codes: 74492-0002-1, 74492-0002-2, 74492-0002-3, and 74492-0002-4.

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 the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Rock Town Distillery Hand Sanitizer (Alcohol Antiseptic 70%, Topical Solution)

Variants: 375 mL (12.7 fl. oz.), 3785 mL (1 gallon), 236 mL (8 oz.), 473 mL (16 oz.)

Lot Numbers:

No lot number or expiration date.

NDC:

74492-0002-1

74492-0002-2

74492-0002-3

74492-0002-4

Quantity: 35,468 containers. Made in USA.