Aripiprazole Tablets Recalled Due to Product Mix-Up

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for aripiprazole tablets, USP, 30 mg. The affected batch has been identified as Lot PA00805 (expires January 2029), affecting 6143 bottles.
• The recall was initiated by Ajanta Pharma USA Inc due to a product mix-up, a quality issue that may cause temporary or medically reversible adverse health consequences.
• Aripiprazole is used to treat bipolar disorder, major depressive disorder, and schizophrenia. It can also be used to treat children with autism and Tourette syndrome.

The FDA has issued a Class II recall for aripiprazole tablets, USP, 30 mg, affecting 6143 bottles. This medication is manufactured by Ajanta Pharma USA Inc in India. The recall was initiated by the branch in Bridgewater, New Jersey on May 27, 2026, and received a Class II classification on June 16, 2026. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences or has a low chance of causing serious adverse health consequences.

The recall was initiated due to a product mix-up; voriconazole tablets were labelled and distributed as aripiprazole tablets. This deficiency affects Lot PA00805, which will expire in January 2029. Ajanta Pharma sent out a public notice via letter; no press release has been issued for this recall.

Aripiprazole is a prescription medication used in combination with other medications to treat mental conditions such as bipolar disorder, major depressive disorder, and schizophrenia. It can also be used to treat irritability symptoms in children with autism as well as Tourette syndrome. Pharmacists should identify and quarantine Lot PA00805, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. June 24, 2026. Accessed June 24, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220708