Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 Recalled by GlaxoSmithKline LLC Due to Failed Release Testing: Coarse Particle Mass for umeclidinium...

Date: December 12, 2023
Company: GlaxoSmithKline LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GlaxoSmithKline LLC directly.

Affected Products

ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10

Quantity: 67,508 inhalers

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GlaxoSmithKline LLC

GlaxoSmithKline LLC has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report