Overview

Ecolab is a chemical manufacturer headquartered in St. Paul, United States, with over 10,000 employees.

API / Drug Master Files

Ecolab holds 0 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

  • 20% CHLORHEXIDINE GLUCONATEInactive1999-05-26

FDA compliance signals

27 FDA enforcement records linked to this company.

  • 4832025-12-05

    Stability sample storage conditions described

  • 4832025-12-05

    Procedures for non-sterile drug products

  • recall — Class II2020-09-02

    Discoloration and Presence of Foreign Substance

  • recall — Class III2019-06-26

    Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.

  • recall — Class II2019-04-03

    Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

  • recall — Class II2019-04-03

    Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

  • recall — Class II2019-04-03

    Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

  • recall — Class II2019-04-03

    Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

  • recall — Class II2019-04-03

    Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

  • 4832019-03-29

    Investigations of discrepancies, failures

  • 4832019-03-29

    Second person sign off

  • 4832019-03-29

    Computer control of master formula records

  • recall — Class II2018-11-28

    Labeling: Label mix-up - the label on the product may not match the formula in the bottle.

  • recall — Class II2018-11-28

    Labeling: Label mix-up - the label on the product may not match the formula in the bottle.

  • 4832018-11-09

    Procedures for non-sterile drug products

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