Lupin Pharmaceuticals Inc.: Drug Recall

Recall Details

Recall Number

D-0899-2023

Classification

Class III

Product Type

Drug

Recalling Firm

Lupin Pharmaceuticals Inc.

Status

Terminated

Date Initiated

06/27/2023

Location

Baltimore, MD, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

3,096 bottles

Reason for Recall

Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

Product Description

Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03

Distribution Pattern

Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.

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. →