FDAClass IIIJanuary 3, 2024

Anoro Ellipta recall

ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured…

Why was Anoro Ellipta recalled?

Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 7Y9S. Exp June 2025

Product
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured…
Recalling firm
GlaxoSmithKline LLC
Quantity
67,508 inhalers
Distribution
Distributed Nationwide in the USA and Puerto Rico.
Recall date
January 3, 2024
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls