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

Five Local Charities Selected in New Jersey and Washington, D.C. Areas
PRINCETON, N.J. – March 30, 2020 – Established in late 2019 by Otsuka America Pharmaceutical, Inc., the Sozosei Foundation has committed $500,000 in donations to five local charities in central New Jersey and Washington, D.C. areas to support those impacted by the Covid-19 Pandemic. 
The charities selected focus on an array of critical services such as providing meals and housing services to at-risk community members including children and the elderly. The local charities are:


  • Meals on Wheels – Mercer County, NJ
  • Food Bank of South Jersey – Trenton, NJ
  • Community Food Bank of New Jersey – Newark, NJ
  • Martha’s Table – Washington, DC
  • Manna Food Center – Montgomery County, MD

“The Sozosei Foundation will focus on supportive efforts in the areas of mental health and kidney diseases, disaster relief and local community outreach,” said William H. Carson, MD, chairman, Sozosei Foundation, and chairman, Board of Directors, Otsuka Pharmaceutical Development & Commercialization, Inc. “We are excited that our initial donations will serve the communities where Otsuka has a major presence.”
These donations represent the first step for the Sozosei Foundation as part of a broader commitment to promote public awareness and education of healthcare issues, as well as to support charitable and qualified exempt organizations. 
“Unfortunately, the COVID-19 virus has already taken an enormous toll on too many families and our hearts go out to those who have been affected by this global pandemic,” said Kabir Nath, board member, Sozosei Foundation and president & CEO, Otsuka North America Pharmaceutical Business. “We are seeing communities around the world come together to protect the most vulnerable and lessen the hardships on the millions of people worldwide who have been impacted the most. We feel privileged to contribute to each of these charitable organizations to help ensure people have access to basic necessities such as food and shelter during this time.” 
"Martha's Table is truly honored to be among the first grantees of the Sozosei Foundation,” said Kim R. Ford, president & CEO, Martha's Table. “This transformative gift will help us to double-down on our mission to support strong children, strong families, and strong communities amid the ongoing COVID-19 crisis. Together, we will ensure Washingtonians have access to the healthy food and essential resources they need during this difficult time."
About the Sozosei Foundation
The Sozosei Foundation is a U.S.-based, private charitable foundation committed to the health and well-being of our communities, including improved patient diagnosis, treatment, care and quality of life, especially for those patients who are most in need.
About Otsuka
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 LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at