Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration (FDA), tort liability and damages to their reputations. Although the decision to initiate a recall is often voluntary, FDA oversees recalls and uses both formal compliance tools and public communications to ensure that recalls are properly completed. This client guide describes FDA recalls, including companies’ responsibilities and FDA’s authority.

Q. When does a recall occur?

A. A recall occurs when a firm removes or corrects a marketed product that violates Food and Drug Administration (FDA)-administered laws and regulations and would be subject to FDA legal action. Recalls are intended to protect the public from products that are harmful, deceptive or defective.