Lupin Pharmaceuticals Inc.: Drug Recall

Recall #D-0537-2025 · 06/27/2025

Class II: Risk

Recall Details

Recall Number: D-0537-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Lupin Pharmaceuticals Inc.
Status: Terminated
Date Initiated: 06/27/2025
Location: Naples, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,724 bottles

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.

Product Description

clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01

Distribution Pattern

Nationwide.

Other Recalls by Lupin Pharmaceuticals Inc.

Class II: Risk 11/13/2025

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Class II: Risk 11/05/2025

Defective container - seal not adhering to bottles
Class II: Risk 07/02/2025

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Class II: Risk 06/20/2025

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Class II: Risk 04/10/2025

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.

View all recalls by Lupin Pharmaceuticals Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.