Cardinal Health Recalls Bevespi Aerosphere Due to Temperature Excursions
Cardinal Health is recalling 355 inhalers of Bevespi Aerosphere due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
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, which typically involves a reasonable probability of temporary or medically reversible health consequences. The hazard is a storage deviation (temperature excursion) without reported illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 355 inhalers of Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.
The affected product is identified by the code 6030180A00 and is manufactured for AstraZeneca Pharmaceuticals, LP. The recall covers units distributed in Florida, Georgia, and South Carolina.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- BEVESPI AEROSPHERE (GLYCOPYRROLATE AND FORMOTEROL FUMARATE)
- Brand
- BEVESPI AEROSPHERE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Inhalation Aerosol
- Affected units
- 355
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)
- 6030180A00
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