Duloxetine Capsule, Delayed Release Pellets
FDA Recall NDC 82009-032
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Duloxetine (NDC 82009-032). A significant event, classified as Class II, was initiated on Nov 24, 2025 by Quallent Pharmaceuticals Health, Llc. The reported reason for this action was: "CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended 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
November 2025 Class II Recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recall Number
Class II Ongoing
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Nov 24, 2025
Dec 10, 2025
3397 bottles
Recall Profile & Regulatory Data
Event ID
98034
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
Batch or Lot Expiration Information
Lot# : 240947C, 240962C, Exp. Date 04/2027
Affected Packages Involved in this Recall
82009-029-05Product
82009-030-10Product
82009-032-10Product
82009-031-30Product
82009-031-90Product
Class II Ongoing
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Aug 08, 2025
Sep 17, 2025
3,591 bottles
Recall Profile & Regulatory Data
Event ID
97425
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
AZ, IN, NJ
Product Description
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10
Batch or Lot Expiration Information
Lot# Lot 240927C, Exp 04/30/2027
Affected Packages Involved in this Recall
82009-029-05Product
82009-030-10Product
82009-032-10Product
82009-031-30Product
82009-031-90Product
Class II Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Jul 25, 2025
Aug 20, 2025
1,856 bottles
Recall Profile & Regulatory Data
Event ID
97336
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NJ, AZ, IN
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
Batch or Lot Expiration Information
Lot# Lot 240539C, Exp 1/31/2027
Affected Packages Involved in this Recall
82009-029-05Product
82009-030-10Product
82009-032-10Product
82009-031-30Product
82009-031-90Product
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.
