Budesonide Inhalation Suspension recall
FDA recall D-0541-2025 · initiated Jun 30, 2025
Cipla USA, Inc. recalled Budesonide Inhalation Suspension in Jun 2025 — an FDA Class II recall (D-0541-2025) because Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 13,680 ampoules
Details
- 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)
- Recalling company
- Cipla Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Jun 30, 2025
- FDA report date
- Jul 30, 2025
Frequently asked
- Was Budesonide Inhalation Suspension recalled?
- Cipla USA, Inc. recalled Budesonide Inhalation Suspension in Jun 2025 — an FDA Class II recall (D-0541-2025) because Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Budesonide Inhalation Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0541-2025 was: Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
- Is a recalled Budesonide Inhalation Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Budesonide Inhalation Suspension are affected?
- Distributed: Distributed Nationwide in the USA. The recall covers these lots — Batch # 4IA0505, Exp 09/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0541-2025.