CLOMIPRAMINE HYDROCHLORIDE
Recalling Firm / Manufacturer: Lupin Pharmaceuticals Inc.
(Naples, FL, United States)
FDA Recall Number: D-0537-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
CLOMIPRAMINE HYDROCHLORIDE
Generic Name
CLOMIPRAMINE HYDROCHLORIDE CAPSULES
Active Substance(s)
Clomipramine Hydrochloride
Administration Route
Oral
National Drug Code (NDC)
68180-492
Total Quantity Recalled
2,724 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Full Product Description
Packaging specifications and labeling details
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Terminated
FDA Enforcement Report Date
July 30, 2025
Firm Initiation Date
June 27, 2025
FDA Classification Date
Jul 21, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # M300464, exp. date June, 2025
Distribution Information
Geographic scope of affected shipments
Nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0537-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508615UTCC