Recalls / Class II
Class IID-0455-2025
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
- Brand name
- Fluoxetine
- Generic name
- Fluoxetine
- Active ingredient
- Fluoxetine Hydrochloride
- Route
- Oral
- NDCs
- 13668-443, 13668-473
- FDA application
- ANDA206937
- Affected lot / code info
- Lot# BDX6K001; Exp. Date 06/30/2025
Why it was recalled
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Recalling firm
- Firm
- Torrent Pharma Inc.
- Manufacturer
- Torrent Pharmaceuticals Limited
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 106 Allen Rd Ste 305, N/A, Basking Ridge, New Jersey 07920-3851
Distribution
- Quantity
- 3672 Bottles
- Distribution pattern
- U.S. Nationwide.
Timeline
- Recall initiated
- 2025-05-27
- FDA classified
- 2025-06-02
- Posted by FDA
- 2025-06-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0455-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.