Anoro Ellipta inhalation powder recalled for failed release testing defect
GlaxoSmithKline is recalling 67,508 Anoro Ellipta inhalers nationwide because coarse particle mass failed release testing and was found out of specification. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: FDA Class III recalls are typically scored 1 or 2 per the rubric. This recall involves a manufacturing defect (out-of-specification particle mass) with no reported illnesses or injuries. The hazard was identified through failed release testing, not adverse patient events.
Plain-English summary
GlaxoSmithKline LLC is recalling 67,508 Anoro Ellipta (umeclidinium bromide and vilanterol trifenatate) inhalers distributed nationwide in the USA and Puerto Rico. The recalled inhalers are from Lot 7Y9S with an expiration date of June 2025. This recall involves the 62.5 mcg/25 mcg inhalation powder formulation.
The recall is being issued because failed release testing identified that coarse particle mass for umeclidinium was out of specification. When coarse particle mass in an inhalation product is out of specification, the drug may not be delivered properly to the lungs, which could affect its intended therapeutic effect.
Patients currently using Anoro Ellipta from the recalled lot should contact their healthcare provider or pharmacist for guidance. Do not discard the medication without consulting a healthcare professional first, as the underlying respiratory condition still requires treatment.
The FDA is classifying this as a Class III recall. No illnesses or injuries have been reported to date.
The recalled product
- Product
- ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE)
- Brand
- ANORO ELLIPTA
- Manufacturer
- GlaxoSmithKline LLC
- Affected units
- 67,508
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)
- Lot #: 7Y9S. Exp June 2025
Distribution
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