FDA Enforcement Reports (Recalls)
The openFDA drug enforcement reports API returns data from the FDA Recall Enterprise System (RES), a database that contains information on recall event information submitted to FDA. Currently, this data covers publicly releasable records from 2004-present. The data is updated weekly.
The procedures followed to input recall information into RES when FDA learns of a recall event are outlined in Chapter 7 of FDA’s Regulatory Procedure Manual The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.