Julio Nunes, MD; Gabriel P.A. Costa, MD; and Joao P. De Aquino, MD, are co-authors of a new study in Pharmacoepidemiology & Drug Safety that examines more than two decades of U.S. Food and Drug Administration drug recall data involving opioid medications.
The analysis identified 286 recall events between 2002 and 2025, affecting over 350 million units, with nearly half attributed to deviations in production quality.
The findings highlight manufacturing and reporting gaps that may have implications for medication safety, pharmacovigilance, and clinical care.