CLASS III Drug recall · Reported 3 Jan 2024 · FDA Enforcement Report
Anoro Ellipta (umeclidinium recalled by GlaxoSmithKline
GlaxoSmithKline is recalling Anoro Ellipta (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg, distributed nationwide in the US. The recall was initiated on 12 Dec 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0160-2024
- FDA event ID
- 93565
- Recalling firm
- GlaxoSmithKline, Durham, NC
- Brand
- Anoro Ellipta
- Manufacturer
- GlaxoSmithKline LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Dec 2023
- FDA classified
- 22 Dec 2023
- Reported
- 3 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Inhalers & Asthma Medication
Timeline
| 12 Dec 2023 | Recall initiated by company | |
| 22 Dec 2023 | Classified by FDA | +10 days |
| 3 Jan 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Which lots are affected?
Lot #: 7Y9S. Exp June 2025
Where was it sold?
Distributed Nationwide in the USA and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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