Stop using nowDrug recall · FDA · Published September 15, 2022
Cipla Budesonide Inhaler Recall: Lack of Sterility Risk
Cipla recalls 0.25mg/2mL Budesonide inhalation suspension due to lack of sterility assurance. Affected lots expire 01/2024. Stop using immediately if you have this prescription medication.
“Cipla Budesonide Inhaler Recall: Lack of Sterility Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34324-cipla-budesonide-inhaler-recall-lack-of-sterility-risk. Based on FDA recall #D-1545-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1545-2022%22&limit=1).
The FDA announced on Sept. 15, 2022, that Cipla is recalling Budesonide Inhalation Suspension due to a lack of assurance of sterility. The recall affects 641,160 ampules distributed nationwide.
The product lacks assurance of sterility. The FDA classified the recall as Class II.
Context
GovInfoNow's records show Cipla has had seven other recalls since Dec. 14, 2020. Recent similar recalls include a Sept. 29, 2022, Arformoterol Inhaler recall for sterility risk and an Aug. 22, 2022, Difluprednate Eye Drops recall for contaminated drops. Other recent recalls of similar products include a March 13, 2026, Lanreotide Injection recall for contamination risk and an Oct. 31, 2025, Phytonadione Injectable Emulsion recall for stability issues.
How to tell if you have this one
Check for the product name: Budesonide Inhalation Suspension 0.25mg/2mL. Look for lot numbers GA20080, GA20081, or GA20094 with expiration date 01/2024.
Brand
Cipla
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
Discard the product if you have the recalled lot numbers (GA20080, GA20081, GA20094) and expiration date 01/2024.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1545-2022 (September 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1545-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.