Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported January 3, 2024
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
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
GlaxoSmithKline LLC recalled ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler … - a low-severity action.
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler … was recalled by GlaxoSmithKline LLC in January 3, 2024. Reason: Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification. Check the official notice for the remedy. Verify recall #D-0160-2024 with the FDA Drug before acting.
The recall
GlaxoSmithKline LLC issued this low-severity FDA Drug recall-Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification.
- Low
- severity level
- Class III
- classification
- January 3, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0160-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0160-2024) was formally reported on January 3, 2024, with the manufacturer initiating the action on December 12, 2023. It is classified under Low severity (Class III), with a current status of Terminated. GlaxoSmithKline LLC is listed as the recalling firm, operating out of Durham, NC. Federal records list the affected scope as 67,508 inhalers.
The documented reason for this recall is: Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification Distribution data in the federal record shows the product reached: Distributed Nationwide in the USA and Puerto Rico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
67,508 inhalers
Related Recalls
6
5 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0160-2024 |
| Date reported | January 3, 2024 |
| Date initiated | December 12, 2023 |
| Recalling firm | GlaxoSmithKline LLC |
| Firm location | Durham, NC |
| Affected scope | 67,508 inhalers |
| Distribution | Distributed Nationwide in the USA and Puerto Rico. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0160-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product 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. Recalled by GlaxoSmithKline LLC. Units affected: 67,508 inhalers.
Why was this product recalled? ▼
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 3, 2024. Severity: Low. Recall number: D-0160-2024.
Where was the recalled product distributed? ▼
Distribution: Distributed Nationwide in the USA and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0160-2024) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 3, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.