← FDA ENFORCEMENT
D-0541-2025Class II

Cipla USA, Inc.

Recalling firm
Cipla USA, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-07-30
Distribution
Distributed Nationwide in the USA
Firm state
NJ
Product quantity
13,680 ampoules
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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)

Code / lot info

Batch # 4IA0505, Exp 09/31/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.