FDAFDA · Food and drugs·Recall number D-0456-2025
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)
Published June 11, 2025 · Recall initiated: May 27, 2025
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- FLUOXETINE
- Manufacturer
- Torrent Pharma Inc.
- Distributor
- U.S. Nationwide.
- UPC
- 0313668443301
- Lot
- Lot# BDX6K001; Exp. Date: 06/30/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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