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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/Over-the-Counter

Ecolab Inc: Equi-Soft and Medi-Stat Antimicrobial Hand Soaps Recalled for Label Mix-Up

Agency Publication Date: November 20, 2018
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Summary

Ecolab Inc. is recalling approximately 26,648 bottles of Equi-Soft Foam and Medi-Stat Foam antimicrobial hand soaps due to a labeling error. The labels on these products may not accurately reflect the actual formula contained inside the bottle. Because these are medicated hand soaps used for infection control, using a product with incorrect active ingredients or concentrations could lead to ineffective hand hygiene or unexpected skin reactions. Consumers should check their supply for the specific lot numbers listed below and contact a healthcare professional if they have concerns.

Risk

A label mix-up means the product inside the bottle does not match the ingredient list or drug facts on the exterior. This poses a risk of ineffective antimicrobial treatment or potential skin irritation if a user is sensitive to the actual (unlabeled) ingredients.

What You Should Do

  1. Check your product labels for Equi-Soft Foam Antimicrobial Hand Soap (25 fl oz/750 mL) or Medi-Stat Foam Antimicrobial Hand Soap (42.3 fl oz/1250 mL).
  2. For Equi-Soft Foam (NDC 47593-521-41), verify if your bottle has lot number L062881 (Expiration 06/20) or 5338HU1800 (Expiration 08/20).
  3. For Medi-Stat Foam (NDC 47593-503-59), verify if your bottle has lot number L062281 (Expiration 06/20).
  4. If your product matches the affected lot numbers, stop using it immediately to ensure proper hand hygiene protocols are maintained.
  5. Contact your healthcare provider or pharmacist for guidance regarding the use of these products, and contact Ecolab Inc. at 1-800-352-5326 for instructions on returning the product and obtaining a refund.
  6. For additional questions or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Drug product return and refund.

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

Affected Products

Product: Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride (25 fl oz / 750 mL)
Model:
NDC 47593-521-41
Recall #: D-0274-2019
Lot Numbers:
L062881 (Exp 06/20)
5338HU1800 (Exp 08/20)
Date Ranges: Expiration 06/20, Expiration 08/20
Product: Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5% (1250 mL / 42.3 fl oz)
Model:
NDC 47593-503-59
Recall #: D-0275-2019
Lot Numbers:
L062281 (Exp 06/20)
Date Ranges: Expiration 06/20

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81510
Status: Resolved
Manufacturer: Ecolab Inc
Sold By: Ecolab distributors; Healthcare supply providers
Manufactured In: United States
Units Affected: 2 products (12,540 bottles; 14,108 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 · 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.