Cipla USA, Inc.: Drug Recall

Recall #D-0043-2025 · 10/23/2024

Class II: Risk

Recall Details

Recall Number: D-0043-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Cipla USA, Inc.
Status: Ongoing
Date Initiated: 10/23/2024
Location: Warren, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,875 boxes (cipla and exlan)

Reason for Recall

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Product Description

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98

Distribution Pattern

USA nationwide.

Other Recalls by Cipla USA, Inc.

Class II: Risk 01/02/2026

Presence of Particulate Matter.
Class III: Low Risk 12/22/2025

Failed PH Specifications
Class II: Risk 11/14/2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 11/14/2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 11/14/2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

View all recalls by Cipla USA, 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.