Torrent Pharma Inc.: Drug Recall

Recall #D-0455-2025 · 05/27/2025

Class II: Risk

Recall Details

Recall Number: D-0455-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Torrent Pharma Inc.
Status: Ongoing
Date Initiated: 05/27/2025
Location: Basking Ridge, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3672 Bottles

Reason for Recall

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

Product Description

Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30

Distribution Pattern

U.S. Nationwide.

Other Recalls by Torrent Pharma Inc.

Class II: Risk 05/27/2025

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II: Risk 04/11/2022

CGMP deviations: tablets cracking
Class II: Risk 12/02/2021

Failed Dissolution Specifications
Class III: Low Risk 12/01/2021

Superpotent; Hydrochlorothiazide

View all recalls by Torrent Pharma 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.