Cipla USA, Inc.: Drug Recall

Recall #D-0225-2026 · 11/14/2025

Class II: Risk

Recall Details

Recall Number
D-0225-2026
Classification
Class II
Product Type
Drug
Recalling Firm
Cipla USA, Inc.
Status
Ongoing
Date Initiated
11/14/2025
Location
Warren, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,744 bottles

Reason for Recall

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

Product Description

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02

Distribution Pattern

Nationwide in the US

Other Recalls by Cipla USA, Inc.

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.