FDA recall D-0516-2025

SUN PHARMACEUTICAL INDUSTRIES INC · Class II · drug

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 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).

Distribution

Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.

Key facts

Status
Ongoing
Initiation date
2025-06-16
Report date
2025-07-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0516-2025