FDA recall D-0455-2025

Torrent Pharma Inc. · Class II · drug

Product

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

Reason for recall

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

Distribution

U.S. Nationwide.

Key facts

Status: Ongoing
Initiation date: 2025-05-27
Report date: 2025-06-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Basking Ridge, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0455-2025