Lisdexamfetamine Capsules Receive Class II Recall Due to Failed Dissolution Testing
The US Food and Drug Administration (FDA) has announced a Class II recall for Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, after the product failed dissolution specifications during a 9-month long-term stability study. Specifically, an out-of-specification result was observed at the 25°C, 60% RH condition, indicating the product may not release its active ingredient as intended. The recall affects 5448 bottles of Lot AD42648, with an expiration date of February 28, 2026. The affected capsules were manufactured by OHM Laboratories and distributed by Sun Pharmaceuticals, Inc., with nationwide distribution through 17 intermediaries.
The recall was initiated voluntarily by Sun Pharmaceutical Industries Inc. on June 16, 2025, and officially classified as Class II by the FDA on July 11, 2025. This classification indicates that use of the product may cause temporary or medically reversible adverse health effects, with a low risk of serious injury. The recalling firm notified customers by letter, and while no press release has been issued, pharmacists should immediately check inventory for NDC 57664-051-88 and ensure removal of affected units to prevent compromised therapeutic outcomes.
Lisdexamfetamine is a central nervous system stimulant indicated for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients aged 6 and older, and for moderate to severe binge eating disorder in adults. Inadequate dissolution may lead to reduced drug absorption, compromising symptom control and increasing the risk of behavioral disruption or suboptimal treatment.
