Class II · Moderate risk
Trelegy Ellipta
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Anoro Ellipta
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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
Affected NDC
0173-0869-10
Compare with the code on your package — it is the most precise check available.
Drug: Vilanterol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Anoro Ellipta umeclidinium bromide and vilanterol trifenatate NDC 00173-0869 |
UMECLIDINIUM BROMIDE 62.5 ug/1; VILANTEROL TRIFENATATE 25 ug/1 | Powder Respiratory (inhalation) |
GlaxoSmithKline LLC | Rx |
- Recalling firm
- GlaxoSmithKline LLC
- NDC code
- 0173-0869-10
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0160-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Vilanterol recalls
See all
Class II · Moderate risk
Trelegy Ellipta
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by GlaxoSmithKline LLC
All 2023 recalls
Class III · Low risk
Tivicay PD
Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
Class III · Low risk
Tivicay (dolutegravir)
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Elevated number of units with out of specification results for leak rate
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
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