SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall #D-0231-2022 · 10/25/2021

Class II: Risk

Recall Details

Recall Number: D-0231-2022
Classification: Class II
Product Type: Drug
Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Status: Terminated
Date Initiated: 10/25/2021
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 36,786 30-count bottles

Reason for Recall

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

Product Description

Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01

Distribution Pattern

Distributed to one distributor who may have further distribute 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 →

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.