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 recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
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
Ongoing
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 Ongoing
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
Ongoing
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.
