Cardinal Health Recalls Arnuity Ellipta Due to Temperature Excursions
Cardinal Health is recalling 353 Arnuity Ellipta inhalers distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.
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 2/5 (Moderate).
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving potential quality deviations without confirmed harm.
Plain-English summary
Cardinal Health Inc. is recalling 353 units of Arnuity Ellipta (fluticasone furoate) 200 mcg inhalers. The recall affects products with lot code 5U3D that were distributed to Florida, Georgia, and South Carolina.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. This condition may compromise the stability and efficacy of the medication.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for a replacement. The product is a prescription-only medication manufactured by GlaxoSmithKline.
The recalled product
- Product
- ARNUITY ELLIPTA (FLUTICASONE FUROATE)
- Brand
- ARNUITY ELLIPTA
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Inhalation Powder
- Affected units
- 353
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)
- 5U3D
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.
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