SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall #D-0312-2025 · 03/04/2025

Class III: Low Risk

Recall Details

Recall Number: D-0312-2025
Classification: Class III
Product Type: Drug
Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Status: Ongoing
Date Initiated: 03/04/2025
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 852 bottles

Reason for Recall

Cross Contamination

Product Description

Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.

Distribution Pattern

Nationwide in the USA

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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.