FDA Drug recall D-0541-2025
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd
- FDA Drug
- Class II
- ongoing
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class II recall of Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd by Cipla Usa, citing lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0541-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-30 |
| Published | 2025-07-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cipla Usa |
| Distribution | US |
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)
Reason
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Identifiers
| ndc | 69097-318-86 |
|---|---|
| ndc | 69097-318-87 |
| ndc | 69097-318-32 |
| ndc | 69097-318-53 |
| ndc | 69097-319-86 |
| ndc | 69097-319-87 |
| ndc | 69097-319-32 |
| ndc | 69097-319-53 |
| ndc | 69097-321-86 |
| ndc | 69097-321-87 |
| ndc | 69097-321-32 |
| ndc | 69097-321-53 |
| code_info | Batch # 4IA0505, Exp 09/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0541-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.