ANORO ELLIPTA — Class III drug recall D-0160-2024
Terminated recall by GlaxoSmithKline LLC, reported 2024-01-03, distributed nationwide. Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
| Recall number | D-0160-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GlaxoSmithKline LLC, Durham, NC, United States |
| Recall initiated | 2023-12-12 |
| Classified | 2023-12-22 |
| Reported by FDA | 2024-01-03 |
| Terminated | 2024-09-12 |
| Distributed | Nationwide (US) |
| Quantity | 67,508 inhalers |
| Reason classes | specification failure |
| NDC | 00173-0869, 00173-0869-06, 00173-0869-10, 00173-0869-61 |
| Lot numbers | 7Y9S |
| Expiration dates | 2025-06-20 |
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 for recall
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0160-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.