February 12, 2021
Taro Pharmaceuticals USA Inc. is pulling three lots of nortriptyline hydrochloride capsules. The February 10, 2021, US Food and Drug Administration (FDA) Enforcement Report, which announced the recall, cited deviations from Current Good Manufacturing Practice regulations.
The recall affects 44,256 bottles of nortriptyline hydrochloride capsules, equivalent to 10-mg base (NDC 51672-4001-1), from lots AC05096, AC05098, and AC05099 (Exp. 10/31/22). The capsules were distributed throughout the United States.
Taro Pharmaceuticals USA voluntarily initiated the recall January 8, 2021. The FDA designated the recall Class II on February 1, 2021, communicating use of the affected drug could cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Nortriptyline is a prescription medication used to treat symptoms of depression and nerve pain.