Class II

Drug Recall: 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: 136

Torrent Pharma Inc. · May 27, 2025

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

U.S. Nationwide.

States Affected

NATIONWIDE

Quantity Affected

3672 Bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0455-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.