Lupin Pharmaceuticals Inc.: Drug Recall

Recall Details

Recall Number

D-0264-2022

Classification

Class III

Product Type

Drug

Recalling Firm

Lupin Pharmaceuticals Inc.

Status

Terminated

Date Initiated

11/19/2021

Location

Baltimore, MD, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

4113 cartons

Reason for Recall

Subpotent Drug

Product Description

Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13.

Distribution Pattern

nationwide within 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. →