What is the most recent FDA action against Macleods Pharmaceuticals Limited?

The most recent FDA event Argus HQ has on file for Macleods Pharmaceuticals Limited is dated 2026-09-30, 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 Macleods Pharmaceuticals Limited 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 Macleods Pharmaceuticals Limited is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Macleods Pharmaceuticals Limited?

1 total: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Macleods Pharmaceuticals Limited?

September 30, 2026. Argus HQ ingests new FDA enforcement records daily.

Macleods Pharmaceuticals Limited — FDA Enforcement History

FDA action counts

Total FDA actions	1
Warning letters	0
Recalls	1
Approval records	0
Form 483 inspection citations	0
Most recent action	September 30, 2026

Key takeaway: Argus HQ has recorded 1 FDA events for Macleods Pharmaceuticals Limited: 0 warning letters, 1 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-09-30 to 2026-09-30. The most severe rating Argus HQ has assigned across this history is "medium". 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. Macleods Pharmaceuticals Limited has 1 FDA event on file. 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.

Enforcement history

On 2026-09-30, Argus HQ recorded an FDA recall for Macleods Pharmaceuticals Limited, rated "medium" severity in Argus HQ's classification: Macleods Pharmaceuticals Limited — Class III recall: Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleo…. 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.

Frequently asked questions

What is the most recent FDA action against Macleods Pharmaceuticals Limited?: The most recent FDA event Argus HQ has on file for Macleods Pharmaceuticals Limited is dated 2026-09-30, 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 Macleods Pharmaceuticals Limited 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 Macleods Pharmaceuticals Limited is observed, this page's event count and history update automatically.
How many FDA actions does Argus HQ track for Macleods Pharmaceuticals Limited?: 1 total: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.
What is the most recent FDA action on file for Macleods Pharmaceuticals Limited?: September 30, 2026. Argus HQ ingests new FDA enforcement records daily.

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Macleods Pharmaceuticals Limited — Class III recall: Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleo… →

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Sep 30, 2026

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Macleods Pharmaceuticals Limited — FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/macleods-pharmaceuticals-limited

MLA

"Macleods Pharmaceuticals Limited — FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/macleods-pharmaceuticals-limited.

Chicago

Argus HQ Research. "Macleods Pharmaceuticals Limited — FDA Enforcement History." Digital Empire Holdings LLC. Accessed October 12, 2026. https://argushq.ai/company/macleods-pharmaceuticals-limited.

BibTeX

@misc{argushq_argushq_ai_company_macleods_pharmaceuticals_limited_2026,
  title = {Macleods Pharmaceuticals Limited — FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/macleods-pharmaceuticals-limited},
  note = {Accessed: October 12, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗