“Cipla Budesonide Inhaler Recall: Leakage Risk in Ampules.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32005-cipla-budesonide-inhaler-recall-leakage-risk-in-ampules. Based on FDA recall #D-0541-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0541-2025%22&limit=1).
The FDA announced on June 30, 2025, that Cipla USA, Inc. is recalling Budesonide Inhalation Suspension due to a lack of assurance of sterility. The agency issued recall number D-0541-2025 for the drug distributed nationwide in the United States.
Packaging: 30 single-dose ampules per carton, five per pouch
NDC#: 69097-319-86 (pouch), 69097-319-87 (carton)
Batch #: 4IA0505
Expiration: 09/31/2026
The hazard
The recall addresses a lack of assurance of sterility following a market complaint regarding leakage and an empty ampoule. The FDA classified the recall as Class II.
Context
GovInfoNow's records show Cipla USA, Inc. has had 12 other recalls on record since June 27, 2023. Other recent recalls of similar products include Cipla Cinacalcet Tablets Recall (June 29, 2026), Cipla Lanreotide Injection Recall (March 13, 2026), and Cipla Phytonadione Injectable Emulsion Recall (October 31, 2025).
How to tell if you have this one
Check for the NDC code 69097-319-86 (pouch) or 69097-319-87 (carton) and batch number 4IA0505. The product is sold in prescription-only packages.
Brand
Cipla USA
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the NDC code 69097-319-86 (pouch) or 69097-319-87 (carton) and batch number 4IA0505.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0541-2025 (June 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0541-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.