Practices  |  Food, Drug, and Medical Device Law

FDA Recalls

Overview

We advise companies on how to comply with regulatory requirements when conducting a voluntary recall. We assist manufacturers and distributors with following best practices to remove and/or correct products that are in violation of laws administered by the Food and Drug Administration (FDA). We also help companies develop a recall strategy which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall. We also have experience handling recalls subject to Consumer Product Safety Commission (CPSC) jurisdiction, and Wiley Rein attorneys have represented manufacturers, distributors, and retailers of consumer products in the full range of CPSC and other product safety regulatory activities.

Representative Experience

  • Assisted both human and pet food manufacturers with voluntary recalls
  • Assisted medical device manufacturers with field correction notices and voluntary recalls