Torrent Pharma Inc.: Drug Recall
Recall #D-0456-2025 · 05/27/2025
Class II: Risk
Recall Details
- Recall Number
- D-0456-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Torrent Pharma Inc.
- Status
- Ongoing
- Date Initiated
- 05/27/2025
- Location
- Basking Ridge, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 972 Cartons
Reason for Recall
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Product Description
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)
Distribution Pattern
U.S. Nationwide.
Other Recalls by Torrent Pharma Inc.
- Class II: Risk 05/27/2025
- Class II: Risk 04/11/2022
- Class II: Risk 12/02/2021
- Class III: Low Risk 12/01/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.