SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall #D-0658-2025 · 09/03/2025

Class II: Risk

Recall Details

Recall Number: D-0658-2025
Classification: Class II
Product Type: Drug
Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Status: Ongoing
Date Initiated: 09/03/2025
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1870 kits

Reason for Recall

Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.

Product Description

Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1

Distribution Pattern

US 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 →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.