Lupin Pharmaceuticals Inc.: Drug Recall

Recall #D-1150-2022 · 06/10/2022

Class II: Risk

Recall Details

Recall Number: D-1150-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Lupin Pharmaceuticals Inc.
Status: Terminated
Date Initiated: 06/10/2022
Location: Baltimore, MD, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,216 bottles

Reason for Recall

Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.

Product Description

Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16

Distribution Pattern

Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product 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 06/27/2025

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.

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.