Budesonide Inhalation Suspension — Class II drug recall D-0541-2025
Ongoing recall by Cipla USA, Inc., reported 2025-07-30, distributed nationwide. Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
| Recall number | D-0541-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cipla USA, Inc., Warren, NJ, United States |
| Recall initiated | 2025-06-30 |
| Classified | 2025-07-22 |
| Reported by FDA | 2025-07-30 |
| Distributed | Nationwide (US) |
| Quantity | 13,680 ampules |
| Reason classes | sterility, packaging |
| NDC | 69097-0318, 69097-0318-32, 69097-0318-53, 69097-0318-86, 69097-0318-87, 69097-0319, 69097-0319-32, 69097-0319-53, 69097-0319-86, 69097-0319-87, 69097-0321, 69097-0321-32, 69097-0321-53, 69097-0321-86, 69097-0321-87 |
| Lot numbers | 4IA0505 |
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 for recall
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0541-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.