CLASS II ONGOING Drug recall · Reported 30 Jul 2025 · FDA Enforcement Report
Budesonide Inhalation Suspension, 5mg/-dose ampules per, five recalled
Cipla USA is recalling Budesonide Inhalation Suspension, 5mg/-dose ampules per, five per, distributed nationwide in the US. The recall was initiated on 30 Jun 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0541-2025
- FDA event ID
- 97170
- Recalling firm
- Cipla USA, Warren, NJ
- Brand
- Budesonide
- Manufacturer
- Cipla USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jun 2025
- FDA classified
- 22 Jul 2025
- Reported
- 30 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Inhalers & Asthma Medication
Timeline
| 30 Jun 2025 | Recall initiated by company | |
| 22 Jul 2025 | Classified by FDA | +22 days |
| 30 Jul 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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)
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Budesonide Inhalation Suspension, 5mg/-dose ampules per, five per recalled?
Yes. Cipla USA recalled Budesonide Inhalation Suspension, 5mg/-dose ampules per, five per on 30 Jun 2025. The recall is Class II and its status is Ongoing. Recall number D-0541-2025.
Why was it recalled?
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Which lots are affected?
Batch # 4IA0505, Exp 09/31/2026
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cipla USA
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
Other Budesonide recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Extended-Release Tablets 9mg recalledBudesonide | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Budesonide Extended-Release Tablets, 9 mg recalled | Golden State Medical Supply | Potency & Assay | IL |
| Drug | CLASS II | Budesonide Inhalation Suspension 25mg/, For Inhalation Only recalledBudesonide | CIPLA | Sterility | Nationwide |
| Drug | CLASS II | Budesonide and Formoterol Fumarate Dihydrate Inhalation recalledBudesonide And Formoterol Fumarate Dihydrate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |