[pending] BUDESONIDE (BUDESONIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0541-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
The recalled product
- Product
- BUDESONIDE (BUDESONIDE)
- Brand
- BUDESONIDE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Drugs
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
- 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 category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27