Duloxetine Capsule, Delayed Release
FDA Recall NDC 76420-633
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Duloxetine (NDC 76420-633). A significant event, classified as Class II, was initiated on May 14, 2026 by Asclemed Usa, Inc.. The reported reason for this action was: "CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA 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
May 2026 Class II Recall: CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Recall Number
Class II Ongoing
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
May 14, 2026
Jun 10, 2026
50 bottles
Recall Profile & Regulatory Data
Event ID
99019
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Asclemed USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
Batch or Lot Expiration Information
Lot# 050725G-30 & 050725F-30, Exp Date: 06/30/2026
Affected Packages Involved in this Recall
76420-633-20Product
76420-633-30Product
76420-633-60Product
76420-633-90Product
76420-633-01Product
76420-633-05Product
76420-633-00Product
76420-634-20Product
76420-634-30Product
76420-634-60Product
76420-634-90Product
76420-634-01Product
76420-634-00Product
76420-636-20Product
76420-636-30Product
76420-636-60Product
76420-636-90Product
76420-636-01Product
76420-623-20Product
76420-623-30Product
76420-623-60Product
76420-623-90Product
76420-623-01Product
76420-623-00Product
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.
