Medications & Supplements/Over-the-Counter

SIREtizer Hand Sanitizer Recalled for Impurities and High Potency

Agency Publication Date: January 19, 2023

Summary

Southwest Iowa Renewable Energy LLC has recalled 12,704 bottles of SIREtizer Hand Sanitizer (80% Ethyl Alcohol) because it contains chemical impurities and may be stronger than labeled. Testing found levels of acetal and acetaldehyde above allowable limits, and lot number 0001 was found to be superpotent. No injuries or adverse incidents have been reported to date.

Risk

High levels of acetal and acetaldehyde can be harmful if absorbed through the skin or inhaled. Additionally, hand sanitizer with higher-than-labeled potency (superpotent) can increase the risk of skin irritation or accidental toxicity if swallowed.

What You Should Do

This recall involves SIREtizer Hand Sanitizer (80% Ethyl Alcohol) packaged in 3.38 oz (100 mL), 10 oz (295 mL), and 16.9 oz (500 mL) bottles with lot numbers 0001, 0005, or 0007.
Check the product packaging for lot numbers and UPC codes. The 10 oz bottles have UPC 860003858820 and the 16.9 oz bottles have UPC 860003858806.
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 Southwest Iowa Renewable Energy LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions 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: SIREtizer Hand Sanitizer (3.38 oz / 100 mL)

Variants: Ethyl Alcohol 80%, 3.38 oz, 100 mL

Lot Numbers:

0001

0005

0007

3,008 bottles affected.

Product: SIREtizer Hand Sanitizer (10 oz / 295 mL)

Variants: Ethyl Alcohol 80%, 10 oz, 295 mL

UPC Codes:

860003858820

Lot Numbers:

0001

0005

0007

120 bottles affected.

Product: SIREtizer Hand Sanitizer (16.9 oz / 500 mL)

Variants: Ethyl Alcohol 80%, 16.9 oz, 500 mL

UPC Codes:

860003858806

Lot Numbers:

0001

0005

0007

9,576 bottles affected.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90953

Status: Active

Manufacturer: Southwest Iowa Renewable Energy LLC

Manufactured In: United States

Units Affected: a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles

Distributed To: Iowa, Nebraska

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 involves SIREtizer Hand Sanitizer (80% Ethyl Alcohol) packaged in 3.38 oz (100 mL), 10 oz (295 mL), and 16.9 oz (500 mL) bottles with lot numbers 0001, 0005, or 0007.

Check the product packaging for lot numbers and UPC codes. The 10 oz bottles have UPC 860003858820 and the 16.9 oz bottles have UPC 860003858806.

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 Southwest Iowa Renewable Energy LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions 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: SIREtizer Hand Sanitizer (3.38 oz / 100 mL)

Variants: Ethyl Alcohol 80%, 3.38 oz, 100 mL

Lot Numbers:

0001

0005

0007

3,008 bottles affected.

Product: SIREtizer Hand Sanitizer (10 oz / 295 mL)

Variants: Ethyl Alcohol 80%, 10 oz, 295 mL

UPC Codes:

860003858820

Lot Numbers:

0001

0005

0007

120 bottles affected.

Product: SIREtizer Hand Sanitizer (16.9 oz / 500 mL)

Variants: Ethyl Alcohol 80%, 16.9 oz, 500 mL

UPC Codes:

860003858806

Lot Numbers:

0001

0005

0007

9,576 bottles affected.