Otsuka is voluntarily recalling certain lots of ABILIFY® (aripiprazole) Tablets due to cross-contamination from extremely small amounts of another active pharmaceutical ingredient previously manufactured on the same equipment. Based on sample testing performed, there is no material patient risk associated with the trace level of contamination found. The voluntary recall has been initiated by Otsuka out of an abundance of caution, with the knowledge of the U.S. Food and Drug Administration. This recall is limited to the United States.

Consumers who have a product that is being recalled and who have concerns, should consult with their healthcare provider or pharmacy. Adverse reactions or quality problems experienced with the use of this product should be reported.

Otsuka America Pharmaceutical, Inc. can be reached by phone at 1-833-468-7852 Monday – Friday, 9 a.m. – 5 p.m. Eastern Time or by email: or The FDA's MedWatch Adverse Event Reporting program can be reached either online or by phone. To complete and submit the report Online: or call 1-800-332-1088.

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April 2024 01US24EBC0008

Top Experts, Lawmakers and Advocates Come Together to Discuss Policy Solutions to Support Growing Number of Americans Living with Mental Illness
WASHINGTON, DC – October 17, 2019– As part of a broader effort to advance conversations around improving mental health care and addressing mental illness as a critical public health issue, Otsuka America Pharmaceutical, Inc. (Otsuka), a leader in developing solutions to meet unmet mental health needs, yesterday hosted the second annual Advancing Mental Health Policy Forum.
The event, held steps away from Capitol Hill in Washington, DC, comes at a critical juncture for mental health care in the U.S., where one in five adults live with a mental health illness. The diverse group of experts from across the mental health community examined the ways in which public policy can improve mental health care. Participants discussed efforts to limit stigma and social barriers, improve access to care for patients and advance treatments that enable patients to live healthier lives.
“The rising rate of suicide among African American children is both tragic and alarming. Our children are facing trauma, they are struggling with racial stigmas, they are bullied for sexual orientation and gender identity and more, and these challenges are crushing them,” said Congresswoman Bonnie Watson Coleman (D-NJ). “I launched the Congressional Black Caucus’s Emergency Task Force on Black Youth Suicide and Mental Health to draw attention to the growing problem, and to help us identify the resources needed to solve it. Part of our task force’s work is to raise awareness, and today’s event provided a welcome platform to continue to lift this issue up publicly and push for change at the national level.”
During an awards reception following the forum, Otsuka recognized Congresswoman Grace Napolitano (D-CA) and Congressman John Katko (R-NY).  Representatives Napolitano and Katko were presented with Otsuka’s BetterTogether Congressional Award, which recognizes policymakers from both sides of the aisle for their collaborative efforts to advance legislation in support of people with mental illness.
“Of the people with mental illness, less than half—43 percent—have had care in the last year.  We have tens of millions of people in this country not getting care for mental illness,” said Kabir Nath, president and CEO, Otsuka North America Pharmaceutical Business. “One reason is because there are significant barriers to that care. Mental health has become a critical public health issue.” 

About Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 1,700 employees in the U.S. develop and commercialize medicines in the areas of mental health, nephrology and cardiology, using cutting-edge technology to address unmet healthcare needs.  Otsuka’s most recently approved product in the U.S. is the first-ever treatment for autosomal dominant polycystic kidney disease, a  genetic disorder in which fluid-filled cysts develop in the kidneys over time, often leading to kidney failure.
OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 11.7 billion in 2018.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka in the U.S. at and connect with us on LinkedInand Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at