Dietary Supplement Recalls

What is a recall? 

A recall is when a dietary supplement distributor or manufacturer removes a product from the market because of either mislabeling or the product presents a health hazard due to contamination, foodborne illness outbreak or other reasons. 

What is mislabeling that could result in a recall? 

Some types of mislabeling that could result in a recall include undeclared ingredients such as fish or shellfish, undeclared allergens such eggs, wheat, etc. 

What is the procedure to conduct a recall? 

Recalls are sometimes determined through internal investigations, external complaints, or FDA inspections. The following are the procedures to follow regardless of the manner in which the recalling firm is made aware of the issue with a supplement. 

  1. Determine whether or not the "issue" rises to the level of a recall. 
  2. Conduct an investigation, documenting everything, including a root cause analysis if possible. 
  3. Prepare a recall submission notification to your local FDA District Recall Coordinator including:
    1. Production Information
    2. Codes (Product Identification numbers)
    3. Recalling Firm
    4. Manufacturer
    5. Firm Responsible for the Violation/Problem
    6. Reason for Recall
    7. Health Hazard Assessment
    8. Volume of Recalled Product
    9. Distribution Pattern
    10. Recall Strategy
  4. Prepare Public Notification
    1. Press Release
    2. Recall letters to supply chain
  5. Conduct an evaluation of the Recall
    1. Conduct an effectiveness of the recall assessment
    2. Submit recall status reports on a monthly basis
    3. Finalize and submit a root cause analysis 
    4. Finalize and submit a corrective action plan
    5. Conduct an analysis for termination of recall
  6. Terminate recall

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