Cipla USA, Inc.: Drug Recall

Recall #D-0218-2026 · 10/24/2025

Class II: Risk

Recall Details

Recall Number: D-0218-2026
Classification: Class II
Product Type: Drug
Recalling Firm: Cipla USA, Inc.
Status: Ongoing
Date Initiated: 10/24/2025
Location: Warren, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

Failed stability specifications: Out of specification for hardness test

Product Description

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.

Distribution Pattern

Nationwide in the USA

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.