SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall Details

Recall Number

D-0516-2025

Classification

Class II

Product Type

Drug

Recalling Firm

SUN PHARMACEUTICAL INDUSTRIES INC

Status

Ongoing

Date Initiated

06/16/2025

Location

Princeton, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

5,448 bottles

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).

Product Description

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

Distribution Pattern

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

Other Recalls by SUN PHARMACEUTICAL INDUSTRIES INC

• Class III: Low Risk 01/27/2026
  This market withdrawal has been initiated in response to Out of Specification (OOS) results observed in in viscosity for Diclofenac Sodium Gel, 3%.
• Class III: Low Risk 12/30/2025
  Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
• Class III: Low Risk 11/26/2025
  Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
• Class II: Risk 10/28/2025
  Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
• Class II: Risk 10/28/2025
  Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

View all recalls by SUN PHARMACEUTICAL INDUSTRIES INC →