FDA Actions Against GlaxoSmithKline LLC

FDA action counts

Enforcement history

On 2024-06-12, Argus HQ recorded an FDA recall for GlaxoSmithKline LLC, rated "medium" severity in Argus HQ's classification: GlaxoSmithKline LLC — Class III recall: Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Eac…. On 2024-01-03, Argus HQ recorded an FDA recall for GlaxoSmithKline LLC, rated "medium" severity in Argus HQ's classification: GlaxoSmithKline LLC — Class III recall: ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1…. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. GlaxoSmithKline LLC has 2 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Frequently asked questions

Is this FDA enforcement data for GlaxoSmithKline LLC official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has GlaxoSmithKline LLC had?

Argus HQ has recorded 2 FDA events for GlaxoSmithKline LLC: 0 warning letters, 2 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against GlaxoSmithKline LLC?

The most recent FDA event Argus HQ has on file for GlaxoSmithKline LLC is dated 2024-06-12, with a severity rating of "medium" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for GlaxoSmithKline LLC automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to GlaxoSmithKline LLC is observed, this page's event count and history update automatically.

Related enforcement actions

• GlaxoSmithKline LLC — Class III recall: Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Eac… →
• GlaxoSmithKline LLC — Class III recall: ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1… →

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