Cardinal Health Recalls Budesonide and Formoterol Inhalers for Temperature Excursions
Cardinal Health Inc. is recalling 905 units of Budesonide and Formoterol Fumarate Dihydrate inhalers due to intermittent temperature exposure during storage.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations (temperature excursions) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 905 units of Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol (80/4.5 mcg). The product is a prescription-only medication manufactured for AstraZeneca Pharmaceuticals LP. The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage.
The affected units are identified by lot code 2000655C00. The recall is classified as FDA Class II. The product was distributed in Florida, Georgia, and South Carolina.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is limited to the specific lot number and distribution states listed above.
The recalled product
- Product
- BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE)
- Brand
- BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Inhalation Aerosol
- Affected units
- 905
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 (1)
- 2000655C00
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 198 products in this recall →Related recalls
Same manufacturer · Cardinal Health Inc.
See all →- HighEnoxaparin syringe bags recalled after being labeled with the wrong strength
FDA (Drugs) · 2025-09-03
- ModerateXolair auto-injectors exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateRecombinate antihemophilic factor vials exposed to temperatures outside labeled storage
FDA (Drugs) · 2025-08-13
- ModerateXolair 75 mg syringes exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateWegovy injection recalled due to temperature exposure during shipping
FDA (Drugs) · 2025-05-07
Same hazard · temperature excursion
See all →- ModerateCyclophosphamide injection vials recalled after a transportation temperature excursion
FDA (Drugs) · 2025-09-24
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30