Cipla USA recalls 0.5mg/2ml Budesonide inhaler ampules due to leakage and empty ampoules. Stop using if you have the specific batch.
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Cipla USA is recalling Budesonide Inhalation Suspension ampules because they may leak or become empty. This could lead to improper medication delivery and potential health risks.
The ampules may leak or become empty, which could cause medication to be delivered incorrectly. This might lead to improper treatment or ineffective use of the inhaler.
Prescription users of Budesonide Inhalation Suspension 0.5mg/2ml ampules. Those with the specific batch number (4IA0505) are most at risk.
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.
Look for the NDC code 69097-319-86 (pouch) or 69097-319-87 (carton) and batch number 4IA0505.
The recall is due to potential leakage and empty ampules, so it is not safe to use the specific batch number 4IA0505.
Check for NDC code 69097-319-86 (pouch) or 69097-319-87 (carton) and batch number 4IA0505.
The recall does not specify a remedy, so contact Cipla USA for guidance.
We’ve drafted a message you can send Cipla USA to request your refund or repair — edit it as you like.
Subject: Recall D-0541-2025 — Cipla USA Cipla USA Hello, I own a Cipla USA that is covered by recall D-0541-2025 from Cipla USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
