Lupin Pharmaceuticals Inc.: Drug Recall

Recall #D-0227-2026 · 11/05/2025

Class II: Risk

Recall Details

Recall Number: D-0227-2026
Classification: Class II
Product Type: Drug
Recalling Firm: Lupin Pharmaceuticals Inc.
Status: Ongoing
Date Initiated: 11/05/2025
Location: Naples, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 52,128 bottles

Reason for Recall

Defective container - seal not adhering to bottles

Product Description

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

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 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 06/27/2025

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
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.