The epidemiology of drug recalls in the United States.

O n January 31, 2012, Pfizer recalled nearly 1 million packs of birth control pills because of concerns that inert and active pills were miscounted and incorrectly ordered in their blister packs. This and other recent recalls highlight concerns about the potential clinical impact of defective and otherwise compromised drug products. However, little is known about the public health burden of drug recalls and whether health care providers are properly notified about clinically important recalls. We sought to quantify the frequency, cause, and extent of distribution of drug recalls in the United States and to evaluate the processes by which the US Food and Drug Administration (FDA) communicates clinically important recall information to health care providers.