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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Topical Products

M Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol

Agency Publication Date: August 15, 2022
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Summary

Medek, LLC is recalling approximately 256 bottles of M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution. FDA laboratory analysis found the product contains methanol and has ethanol levels below what is listed on the label. No injuries or incidents have been reported to date. The recalled product was sold in 128 oz (3,785 mL) bottles in Texas. If you have used this product, contact your healthcare provider or pharmacist.

Risk

Methanol exposure can cause serious health issues including nausea, vomiting, blurred vision, permanent blindness, seizures, coma, or death. Because the ethanol level is lower than stated, the product is subpotent and may not effectively kill germs as intended.

What You Should Do

  1. This recall affects all lots of M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution, packaged in 128 oz (3,785 mL) bottles.
  2. Identify the product by checking the NDC codes on the label: 77797-001-01 (Made by Grupo Plast-Y-Kosas S.A. de C.V.) or 75432-001-02 (Distributed by Medek, LLC).
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solutionby M
Variants: 128 oz (3,785 mL)
Lot Numbers:
All lots
NDC:
77797-001-01
75432-001-02

Product Images

Image โ€“ Drug Facts Panel

Image โ€“ Drug Facts Panel

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86414
Status: Resolved
Manufacturer: MEDEK LLC
Sold By: Retailers in Texas
Manufactured In: Mexico, United States
Units Affected: 256 bottles
Distributed To: Texas

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 ยท FDA Press Release ยท 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.