Budesonide inhalation ampoules recalled after leakage and empty ampoule complaint
Budesonide Inhalation Suspension 0.5 mg/2 mL is being recalled for lack of assurance of sterility after a market complaint was received for leakage and an empty ampoule. 13,680 ampoules affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: an inhalation medicine with no assurance of sterility after a leakage complaint, with no infection or injury reported in the source.
Plain-English summary
Budesonide Inhalation Suspension, 0.5 mg/2 mL, 30 single-dose ampules per carton, five per pouch, prescription only, manufactured by Cipla Ltd. of Pithampur, India for Cipla USA, Inc., is being recalled. The action covers 13,680 ampoules.
The stated reason is a lack of assurance of sterility: a market complaint was received for leakage and an empty ampoule. The FDA classified the action as Class II. The source does not report any infection or injury.
The affected batch is 4IA0505, expiring 09/2026. Distribution was nationwide in the USA.
Patients holding the affected batch should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the manufacturer.
The recalled product
- Product
- BUDESONIDE (BUDESONIDE)
- Brand
- BUDESONIDE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Inhalation suspension
- Affected units
- 13,680
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # 4IA0505
- Exp 09/31/2026
Distribution
Distributed nationwide across the United States.
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