D-0537-2025 Class II Terminated
FDA drug recall D-0537-2025 was initiated by Lupin Pharmaceuticals Inc. on Jun 27, 2025 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry. The recall status is terminated (terminated Jan 5, 2026). Affected quantity: 2,724 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 30, 2025
- Initiation Date
- Jun 27, 2025
- Termination Date
- Jan 5, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,724 bottles
Product Description
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Reason for Recall
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Distribution Pattern
Nationwide.
Code Information
Lot # M300464, exp. date June, 2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0537-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026