Budesonide Inhalation Suspension recall: Sterility Concern
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ…
Why was Budesonide Inhalation Suspension recalled?
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch # 4IA0505, Exp 09/31/2026
- Product
- Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ…
- Recalling firm
- Cipla USA, Inc.
- Quantity
- 13,680 ampoules
- Distribution
- Distributed Nationwide in the USA
- Recall date
- July 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)