Cipla USA, Inc.: Drug Recall

Recall #D-0541-2025 · 06/30/2025

Class II: Risk

Recall Details

Recall Number: D-0541-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Cipla USA, Inc.
Status: Ongoing
Date Initiated: 06/30/2025
Location: Warren, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13,680 ampoules

Reason for Recall

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

Product Description

Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)

Distribution Pattern

Distributed 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.