Sun Pharma Recalls Lisdexamfetamine 60 mg Capsules Due to Stability Test Failure
Sun Pharmaceutical Industries Inc has voluntarily initiated a Class II recall of Lisdexamfetamine Dimesylate Capsules, 60 mg, following an out-of-specification (OOS) result during a routine 9-month long-term stability test. The affected lot, AD42648, with an expiration date of February 28, 2026, failed to meet dissolution specifications at the 25°C, 60% relative humidity station. This deficiency, identified in 5448 bottles packaged in 100-count containers, could potentially impact the therapeutic effectiveness of the medication over time.
The product, Rx-only and classified as a Schedule II controlled substance, was manufactured by OHM Laboratories in New Brunswick, NJ, and distributed by Sun Pharmaceuticals Inc, based in Cranbury, NJ. The recall, initiated on June 16, 2025, was communicated via formal letters to consignees and is currently ongoing. The product had been distributed to 17 wholesale distributors, with possible nationwide redistribution, increasing the potential for broader impact across pharmacy networks.
Lisdexamfetamine Dimesylate is primarily indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older. It is also approved for the treatment of moderate to severe binge eating disorder in adults. As a prodrug of dextroamphetamine, its efficacy is dependent on timely and adequate release and absorption, making dissolution performance critical to clinical outcomes. Pharmacists should check inventory for lot AD42648 and follow proper procedures for quarantine and return to ensure patient safety.
