Clomipramine Hydrochloride Capsule
FDA Recall NDC 68180-494
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 Clomipramine Hydrochloride (NDC 68180-494). A significant event, classified as Class II, was initiated on Jun 27, 2025 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Jun 27, 2025
Jul 30, 2025
2,724 bottles
Recall Profile & Regulatory Data
Event ID
97159
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jan 05, 2026
Product Description
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Batch or Lot Expiration Information
Lot# M300464, exp. date June, 2025
Affected Packages Involved in this Recall
68180-492-01Product
68180-492-07Product
68180-492-09Product
68180-492-06Product
68180-493-01Product
68180-493-07Product
68180-493-09Product
68180-493-06Product
68180-494-01Product
68180-494-07Product
68180-494-09Product
68180-494-06Product
Class II Terminated
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Apr 10, 2025
Apr 30, 2025
2724 bottles
Recall Profile & Regulatory Data
Event ID
96681
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Termination Date
Jan 05, 2026
Product Description
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01
Batch or Lot Expiration Information
Lot# : M300442, Exp Date: 6/30/2025
Affected Packages Involved in this Recall
68180-492-01Product
68180-492-07Product
68180-492-09Product
68180-492-06Product
68180-493-01Product
68180-493-07Product
68180-493-09Product
68180-493-06Product
68180-494-01Product
68180-494-07Product
68180-494-09Product
68180-494-06Product
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.
