MedicineWatch US
Class II Recall

SUN PHARMACEUTICAL INDUSTRIES INC

Product
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
Reason
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).
Classification
Class II
Status
Ongoing
Lot
Lot # AD42648, Exp 02/28/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
SUN PHARMACEUTICAL INDUSTRIES INC — Class II Recall | MedicineWatch US