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.
What this means for you
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.
Related recalls
Same brand · BUDESONIDE
- HighBudesonide inhalation ampules contain black and brown specks and particles
FDA (Drugs) · 2026-06-17
- HighFDA Recalls Budesonide Extended-Release Tablets for Failed Dissolution
FDA (Drugs) · 2024-02-07
- HighInhalation Drug Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-10-05
Same manufacturer · Cipla USA, Inc.
See all →- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- SevereCinacalcet Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2026-07-08
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits
FDA (Drugs) · 2026-07-08
- HighCipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
Same hazard · sterility assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereArrow drainage and thoracentesis kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24