D-0541-2025 Class II Ongoing
FDA drug recall D-0541-2025 was initiated by Cipla USA, Inc. on Jun 30, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. The recall status is ongoing. Affected quantity: 13,680 ampoules.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 30, 2025
- Initiation Date
- Jun 30, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,680 ampoules
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)
Reason for Recall
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Batch # 4IA0505, Exp 09/31/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0541-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026