Label Mistake Prompts Antipsychotic Recall

Mislabeled bottles have prompted Alembic Pharmaceuticals Limited to recall a single lot of aripiprazole tablets. According to the July 1, 2020, US Food and Drug Administration (FDA) Enforcement Report, bottles labeled to contain 30 tablets of 2-mg aripiprazole actually contain 100 tablets of 5-mg aripiprazole.

The recall affects aripiprazole tablets, 2 mg, 30 tablets per bottle (NDC 62332-097-30), from lot 1905003298 (Exp. 1/31/21). The bottles were distributed throughout the United States.

Alembic Pharmaceuticals initiated the recall June 10, 2020. On June 24, 2020, the FDA designated the recall Class II. Products affected by Class II recalls could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm. 

Aripiprazole is a prescription antipsychotic medication used to treat patients with schizophrenia, bipolar disorder, depression, and Tourette syndrome.

—Jolynn Tumolo