FDA action counts
| Total FDA actions | 2 |
|---|---|
| Warning letters | 0 |
| Recalls | 2 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | June 17, 2026 |
Enforcement history
On 2026-05-27, Argus HQ recorded a FDA recall for Haleon US Holdings LLC, rated "high" severity in Argus HQ's classification: Haleon US Holdings LLC — Class II recall: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for Haleon US Holdings LLC, rated "critical" severity in Argus HQ's classification: Haleon US Holdings LLC — Class I recall: Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (U… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Haleon US Holdings LLC has 2 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). 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. Counting an FDA record here does not by itself indicate an unresolved problem -- warning letters, recalls, and inspection observations are frequently closed out once a firm completes FDA-required corrective action.
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Haleon US Holdings 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.
Frequently asked questions
- How many FDA actions has Haleon US Holdings LLC had?
- Argus HQ has recorded 2 FDA events for Haleon US Holdings 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 Haleon US Holdings LLC?
- The most recent FDA event Argus HQ has on file for Haleon US Holdings LLC is dated 2026-06-17, with a severity rating of "critical" 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 Haleon US Holdings 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 Haleon US Holdings LLC is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Haleon US Holdings LLC?
- 2 total: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.
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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Haleon US Holdings LLC — FDA Compliance Timeline. Digital Empire LLC. Retrieved from https://argushq.ai/company/haleon-us-holdings-llc
"Haleon US Holdings LLC — FDA Compliance Timeline." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/haleon-us-holdings-llc.
Argus HQ Research. "Haleon US Holdings LLC — FDA Compliance Timeline." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/haleon-us-holdings-llc.
@misc{argushq_argushq_ai_company_haleon_us_holdings_llc_2026,
title = {Haleon US Holdings LLC — FDA Compliance Timeline},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/haleon-us-holdings-llc},
note = {Accessed: July 13, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗