Cipla USA, Inc. 2025-07-30 Health serious FDA
Health · FDA · Recall #FDA-D-0541-2025
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per… Recall
Issued July 30, 2025 · Cipla USA, Inc.
In July 2025, Cipla USA, Inc. recalled the Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
What you should do
- 1 Stop using Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Cipla USA, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Cipla USA, Inc.
- Category
- Health
- Recall date
- July 30, 2025
- Units affected
- Not reported
- Sold at
- Distributed Nationwide in the USA
- Recall number
- FDA-D-0541-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Cipla USA, Inc. has 9 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.