Fluoxetine Tablet
FDA Recall NDC 13668-443
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Fluoxetine (NDC 13668-443). A significant event, classified as Class II, was initiated on May 27, 2025 by Torrent Pharmaceuticals Limited. The reported reason for this action was: "CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
May 27, 2025
Jun 11, 2025
3672 Bottles
Recall Profile & Regulatory Data
Event ID
96983
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Torrent Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
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
Batch or Lot Expiration Information
Lot# BDX6K001; Exp. Date 06/30/2025
Affected Packages Involved in this Recall
13668-443-74Product
13668-443-10Product
13668-443-01Product
13668-443-30Product
13668-443-91Product
13668-473-10Product
13668-473-74Product
13668-473-30Product
13668-473-01Product
13668-473-91Product
Class II Completed
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
May 27, 2025
Jun 11, 2025
972 Cartons
Recall Profile & Regulatory Data
Event ID
96983
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Torrent Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
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)
Batch or Lot Expiration Information
Lot# BDX6K001; Exp. Date: 06/30/2025
Affected Packages Involved in this Recall
13668-443-74Product
13668-443-10Product
13668-443-01Product
13668-443-30Product
13668-443-91Product
13668-473-10Product
13668-473-74Product
13668-473-30Product
13668-473-01Product
13668-473-91Product
13668-473-70Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
