Antipsychotic Recalled

Aurobindo Pharma USA Inc. is recalling more than 20,000 bottles of olanzapine tablets for failing to meet impurity/degradation specifications. The June 24, 2020, US Food and Drug Administration (FDA) Enforcement Report provided no further details on the reason for the voluntary recall.  

The recall affects the following products, which were distributed throughout the United States:

• olanzapine tablets, 2.5 mg, 30-count bottles (NDC 66993-680-30) manufactured by Aurolife Pharma for Prasco Laboratories, from lot 561180046A1 (Exp. 8/20), and
• olanzapine tablets, 7.5 mg, 30-count bottles (NDC 66993-682-30) manufactured by Aurolife Pharma for Prasco Laboratories, from lot 563180012A1 (Exp. 8/20). 

Aurobindo Pharma USA initiated the voluntary recall May 26, 2020. The FDA designated the recall Class III on June 17, 2020, communicating use of the affected tablets is not likely to cause harm. 

Olanzapine is a prescription antipsychotic medication used to treat patients with schizophrenia, bipolar disorders, and depression.

—Jolynn Tumolo