Torrent Pharma Inc. recalls Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-38
Recalled June 11, 2025 · FDA recall D-0456-2025 · Torrent Pharma
Hazard
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. · FDA Class II
Units
972 Cartons
Sold at
U.S. Nationwide.
Description
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Product
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)
Manufacturer(s)
Torrent Pharma Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →