Class IIReported 2025-07-23

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC

Reason for Recall

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).

Recall Number

D-0516-2025

Classification

Class II

Status

Ongoing