Lupin Pharmaceuticals Inc.: Drug Recall

Recall Details

Recall Number

D-0053-2025

Classification

Class II

Product Type

Drug

Recalling Firm

Lupin Pharmaceuticals Inc.

Status

Terminated

Date Initiated

10/23/2024

Location

Baltimore, MD, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

146,322 bottles

Reason for Recall

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Product Description

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

Distribution Pattern

Product was distributed to 30 wholesalers/distributors 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. →