Alembic Pharmaceuticals Limited: Drug Recall

Recall Details

Recall Number

D-0326-2021

Classification

Class I

Product Type

Drug

Recalling Firm

Alembic Pharmaceuticals Limited

Status

Terminated

Date Initiated

03/17/2021

Location

Tajpura, N/A, India

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

12288 bottles

Reason for Recall

Labeling: Label-mixup

Product Description

Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30

Distribution Pattern

Nationwide within the United States

Other Recalls by Alembic Pharmaceuticals Limited

• Class III: Low Risk 12/16/2025
  Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
• Class III: Low Risk 10/10/2025
  Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
• Class II: Risk 07/25/2025
  CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
• Class II: Risk 05/09/2025
  Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
• Class II: Risk 05/07/2025
  Failed Impurities/Degradation Specifications

View all recalls by Alembic Pharmaceuticals Limited →