Overview
- Sun Pharmaceutical Industries initiated a voluntary nationwide recall on Oct. 28 for lisdexamfetamine dimesylate capsules, the generic version of Vyvanse, following FDA enforcement testing.
- The affected product, manufactured by OHM Laboratories and distributed by Sun Pharma, is packaged in 100‑count bottles across seven strengths from 10 mg to 70 mg.
- The FDA classified the action as a Class II recall on Oct. 30, indicating the probability of serious adverse health consequences is remote.
- Failures were observed at a 12‑month stability check for dissolution, with pharmacy boards cautioning that suboptimal dissolution may reduce efficacy rather than pose an acute safety risk.
- Patients are advised to verify lot numbers on their bottles—covering expirations from February to May 2026 and shipments dating May to November 2024—and to contact their pharmacy or prescriber for guidance, replacement, or refund.