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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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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Laboratorios Jaloma S.A. de C.V.: Antiseptic Hand Sanitizer Recalled for Manufacturing Deviations

Agency Publication Date: August 28, 2020
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Summary

Laboratorios Jaloma S.A. de C.V. has voluntarily recalled 211,875 bottles of Jaloma Antiseptic Hand Sanitizer (Ethyl Alcohol 62% with Vitamin E) due to serious manufacturing quality deviations (cGMP deviations). The recall includes both the 16.9-ounce and 4-ounce sizes that were distributed across the United States and Canada. These products are being recalled because the manufacturer's processes did not meet safety and quality standards required by the FDA.

Risk

Failure to follow current Good Manufacturing Practice (cGMP) standards can lead to products that are ineffective, contaminated, or contain incorrect ingredient levels, potentially resulting in skin irritation or failure to prevent the spread of germs as intended.

What You Should Do

  1. Check your medicine cabinet or storage for Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, in 16.9 Fl. Oz. (500 mL) or 4 Fl. Oz. (120 mL) bottles.
  2. Verify the identifying numbers on the packaging: for 16.9 oz bottles, look for NDC 65055-600-02, UPC 759684515033, and Lot numbers 0005295 (Exp 4/2022) or 0006373 (Exp 5/2022).
  3. For 4 oz bottles, look for NDC 65055-600-01, UPC 75968455026, and Lot numbers 0005412 (Exp 4/2022), 0007134 (Exp 5/2022), 0007834 (Exp 5/2022), or 0009239 (Exp 6/2022).
  4. Contact your healthcare provider or pharmacist if you have experienced any problems that may be related to using this product.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact Laboratorios Jaloma S.A. de C.V. for further instructions.
  6. For more information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall baseline remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E (16.9 Fl. Oz. / 500 mL)
Model:
65055-600-02
UPC Codes:
759684515033
Lot Numbers:
0005295 (Exp 4/2022)
0006373 (Exp 5/2022)
Date Ranges: Expiration 4/2022, Expiration 5/2022
Product: Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E (4 Fl. Oz. / 120 mL)
Model:
65055-600-01
UPC Codes:
75968455026
Lot Numbers:
0005412 (Exp 4/2022)
0007134 (Exp 5/2022)
0007834 (Exp 5/2022)
0009239 (Exp 6/2022)
Date Ranges: Expiration 4/2022, Expiration 5/2022, Expiration 6/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86167
Status: Resolved
Manufacturer: Laboratorios Jaloma S.A. de C.V.
Sold By: Nationwide United States and Canada
Manufactured In: Mexico
Units Affected: 211,875 bottles
Distributed To: Nationwide

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 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.