Cosmetic Recalls

What is a cosmetic recall?

A recall is when a cosmetic distributor and/or manufacturer requests that a product be removed from the market. Recalls are based on either adulteration or misbranding. In the case of adulterations where there is a potential for harm to the consumer recalls are strongly recommended. Misbranding is a case by case situation for each manufacturer and/or distributor. Some manufacturers and/or distributors do not find that certain misbranded statements rise to the level to cause potential harm to the consumer and therefore do not see the need for a recall. 

Can FDA mandate a recall? 

FDA has no authority under the Federal Food, Drug & Cosmetic Act to order a recall of a cosmetic. However, when FDA feels there is a violation of the laws FDA can request that manufacturers, private labelers and/or distributors recall a product. Many companies feel obligated to comply with FDA's request for recall because of the potential for future retaliation by FDA, founded or unfounded. 

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: 

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