FDA Drugs recall ·
Budesonide Inhalation Suspension, 0.5mg/2ml… recall
- Recall number
- D-0541-2025
- Date
- (initiated June 30, 2025)
- Company / brand
- Cipla USA, Inc.
10 Independence Blvd, Warren, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 13,680 ampoules
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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)
Why was it recalled?
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch # 4IA0505, Exp 09/31/2026
Distribution
Distributed Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0541-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.