Based on sample testing performed, there is no material patient risk associated with the level of contamination found. The detected amount of the ingredient was confirmed to be extremely small and significantly below the permitted daily exposure (PDE) established by the U.S. FDA.
The Abilify® (aripiprazole) Tablets affected are the 5 mg, 10 mg, 15 mg, and 30 mg doses. The 2 mg and 20 mg doses are not affected. The recall will not affect product availability as there are other sources of aripiprazole tablets available in the U.S. market for patient use, including 2 mg and 20 mg.
Source: Otsuka America Pharmaceutical, Inc
