SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall #D-0940-2023 · 07/13/2023

Class II: Risk

Recall Details

Recall Number: D-0940-2023
Classification: Class II
Product Type: Drug
Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Status: Terminated
Date Initiated: 07/13/2023
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7313 bottles

Reason for Recall

Presence of Foreign Substance: Metal embedded in a tablet.

Product Description

Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.

Distribution Pattern

Nationwide

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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.