FDA recall D-0456-2025

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)

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-0456-2025