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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted January 23, 2025
Glutathione Distributor Warned by FDA
On November 13, 2024, the FDA issued a Warning Letter to Western Innovations, Inc., following an inspection of the company’s facility which found its acetyl-glutathione dietary supplements to be adulterated because they were, packed, labeled or held under conditions that do not meet Current Good Manufacturing Practices (cGMP).
(See ConsumerLab’s Review of Glutathione Supplements for tests of related products.)
Violations noted by the FDA included failure to establish specifications for each component used in the manufacture of a dietary supplement, failure to establish and follow written procedures for the responsibilities of the quality control operations, and failure to establish procedures for returned dietary supplements.
According to the FDA's letter, the company also failed to provide heavy metal or microbial test specifications.
Western Innovations, Inc. must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.
For more information, use the link below.
Warning: Western Innovations, Inc.
See related recalls and warnings:
Glutathione Supplement Maker Warned For Manufacturing Violations and Drug Claims
West Coast Laboratories Warned for Manufacturing, Labeling Violations
Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
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Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
Please complete the form below as accurately as possible. You may need to check the label on the drug.
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