FDA Drug recall D-0160-2024
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Man…
- FDA Drug
- Class III
- terminated
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class III recall of ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Man… by Glaxosmithkline, citing failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0160-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-12-12 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glaxosmithkline |
| Distribution | US |
Product
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
Reason
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Identifiers
| ndc | 0173-0869-10 |
|---|---|
| ndc | 0173-0869-06 |
| ndc | 0173-0869-61 |
| code_info | Lot #: 7Y9S. Exp June 2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0160-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.