FDA Drugs recall ·
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose)… recall
- Recall number
- D-0456-2025
- Date
- (initiated May 27, 2025)
- Company / brand
- Torrent Pharma Inc.
106 Allen Rd Ste 305, Basking Ridge, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 972 Cartons
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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)
Why was it recalled?
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# BDX6K001; Exp. Date: 06/30/2025
Distribution
U.S. Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0456-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.