The only instances where the FDA will order a recall are when the recall involves a medical device, human tissue products, or infant formula. Moreover, the FDA has the authority to determine the scope and extent of these recalls. Under the guidelines outlined in Title 21 of the Code of Federal Regulations, the FDA’s role is to:
- Monitor the company recalls
- Assess the company’s actions
- Investigate the product for its defectiveness
- Make sure the product is either destroyed or reconditioned
