Ascend Laboratories Recalls Aripiprazole Lot Nationwide Due to Superpotent Tablets

The US Food and Drug Administration (FDA) has announced a Class II recall involving aripiprazole tablets, USP, 10 mg in 30-count bottles. The product was manufactured by Alken Laboratories Ltd. in India and distributed nationwide in the United States by Ascend Laboratories, LLC, headquartered in Parsippany, New Jersey. A total of 2256 bottles from Lot #24144162 (expiration date September 2027) are impacted. The recall, identified under Recall Number D-0645-2025, was voluntarily initiated by the company on August 28, 2025, with classification confirmed on September 12, 2025.

The recall was issued due to the product being superpotent, meaning the tablets contain more active pharmaceutical ingredient than intended. This defect poses significant clinical concerns, as altered potency can lead to an increased risk of adverse effects in patients. The FDA has classified the recall as Class II, indicating that exposure to the drug product may cause temporary or medically reversible health consequences, though the likelihood of serious harm is considered remote. Notification to consignees was conducted via direct letter, and the recall remains ongoing with no termination date currently available.

Aripiprazole is an atypical antipsychotic primarily prescribed for the treatment of schizophrenia, bipolar disorder, major depressive disorder (as adjunct therapy), and irritability associated with autism spectrum disorder. Pharmacists are advised to carefully review stock for the affected lot and counsel patients accordingly. While no public press release has been issued by the recalling firm, pharmacists should remain vigilant in identifying and removing the affected product to prevent potential risks to patient safety.