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FDA Alert: Otsuka Initiates Voluntary Nationwide Recall of Certain Lots of Abilify (aripiprazole) Tablets Due to Drug Product Cross-Contamination on Manufacturing Equipment

April 9, 2024

Audience: Healthcare Provider, Pharmacy, Consumer

PRINCETON, N.J. (April 9, 2024) – Otsuka America Pharmaceutical, Inc. (Otsuka) is voluntarily recalling certain Abilify (aripiprazole) Tablets in the United States due to cross-contamination from extremely small amounts of another active pharmaceutical ingredient manufactured on the same equipment. The Abilify® (aripiprazole) Tablets affected are the 5 mg, 10 mg, 15 mg, and 30 mg doses. The 2 mg and 20 mg doses are not affected. Based on sample testing performed, there is no material patient risk associated with the level of contamination found. The detected amount of the ingredient was confirmed to be extremely small and significantly below the permitted daily exposure (PDE) established by the U.S. Food and Drug Administration (FDA). The voluntary recall has been initiated by Otsuka in the United States out of an abundance of caution, with the knowledge of the U.S. Food and Drug Administration (FDA). This recall is limited to the United States.

The recall will not affect product availability as there are other sources of aripiprazole tablets available in the U.S market for patient use, including 2 mg and 20 mg doses of Abilify® (aripiprazole).

Abilify Maintena® (aripiprazole), Abilify Asimtufii® (aripiprazole) extended-release injectable suspensions, and Abilify MyCite® (aripiprazole tablets with sensor), are not affected by this recall.

There is an ongoing investigation to determine the cause of the cross-contamination and appropriate corrective actions are being put in place to ensure there is not a recurrence. A safety assessment has been conducted and there are no new safety issues identified, and the reported adverse events in the company safety database during the period of January 1, 2021, to March 31, 2024, were consistent with the well-established safety profile of aripiprazole.

Wholesalers that have Abilify Tablets which are being voluntarily recalled, should examine their inventory, cease distributing any impacted product, and return any impacted lots to Otsuka America Pharmaceutical, Inc.

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:

  • The FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. To complete and submit the report Online: www.fda.gov/medwatch/report.htm.

  • For regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

Source: Otsuka America Pharmaceutical, Inc.

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