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.
Recall initiated: 20250527
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated