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: global_intake@otsuka-us.com or ProductComplaints@otsuka-us.com. The FDA's MedWatch Adverse Event Reporting program can be reached either online or by phone. To complete and submit the report Online: www.fda.gov/medwatch/report.htm or call 1-800-332-1088.

Read more here: https://www.otsuka-us.com/news/otsuka-us-voluntary-recall

April 2024 01US24EBC0008

Based on the corporate philosophy of Otsuka-people creating new products for better health worldwide, the Otsuka group of companies strives to contribute to the health of people around the world.

As a health-related company, all of us at Otsuka are deeply saddened by and concerned about the situation in Ukraine, and sincerely hope that the Ukrainian people can again lead safe and peaceful lives as soon as possible.

Otsuka Holdings Co., Ltd. has decided to donate 20 million yen (approximately USD 164,000) through the Japanese Red Cross Society for humanitarian assistance to people whose lives have been severely affected in Ukraine and who have been evacuated to surrounding countries.

In addition, Otsuka Holdings is providing support to patients and people involved in treatment through the provision of Otsuka products, including pharmaceuticals.

Otsuka group companies and their employees are also making financial and product contributions to support humanitarian assistance to the people of Ukraine, including the contributions described below (as of March 25, 2022):

Companies based in North America

■Otsuka America Pharmaceutical, Inc./Otsuka Pharmaceutical Development & Commercialization, Inc.

-Set up a matching gift program with the goal to contribute a total of USD 100,000 (USD 50,000 from employees and an equal amount by the company). Matching gifts are donated to several international charitable organizations.

■Taiho Oncology, Inc. (on behalf of Taiho subsidiaries in North America and Europe)

-Pledged a donation of USD 25,000 to the American Red Cross.

-Also set up a matching gift program for employee contributions of up to USD 500 per employee.

■MegaFood

-Set up a matching gift program for employee donations to several charities with the goal to contribute USD 50,000 in total.

■Daiya Foods, Inc.

-Set up a matching gift program for employee donations of up to CAN 500 per employee to the charity of their choice that supports humanitarian relief efforts related to Ukraine.

-Donating Daiya products, Free From Cards translated into Ukrainian, and coupons to organizations in Vancouver, Toronto and Winnipeg that support refugees arriving from Ukraine.   

Companies based In Europe

■Otsuka Pharmaceutical Europe Ltd.

-Pledged a donation of €100,000 (USD 110,000) to the Red Cross Ukraine Humanitarian Appeal

■Nutrition & Santé SAS

-To date, has donated 24 palettes of the company's products such as cookies and cereals to refugee centers in Poland.

■ Otsuka Novel Products GmbH

-To date, has coordinated with the Stop TB Partnership to enable Otsuka’s anti-tuberculosis product DELTYBA to reach treatment sites for refugees in areas adjacent to Ukraine.