Since the fall 2023, the United States has been facing a massive recall of apple cinnamon fruit purees (like apple sauce) due to the presence of elevated levels of lead which caused the product to be considered adulterated under the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”).
Earlier this month, the U.S. Food and Drug Administration (“FDA”) completed guidance to help companies remove violative products from the market in a swift and effective manner. The guidance describes the precautionary steps companies should take to develop recall policies and procedures that include training, planning, and recordkeeping to reduce the amount of time a recalled product is exposed to the public.