FDA action counts
| Total FDA actions | 3 |
|---|---|
| Warning letters | 0 |
| Recalls | 0 |
| Approval records | 3 |
| Form 483 inspection citations | 0 |
| Most recent action | July 1, 2026 |
Enforcement history
On 2026-06-23, Argus HQ recorded a FDA approval for MACLEODS PHARMS LTD, rated "info" severity in Argus HQ's classification: MACLEODS PHARMS LTD — ANDA approval: RIFAPENTINE (unspecified) An FDA approval record reflects FDA clearing a specific drug or biologic application for marketing. On 2026-06-23, Argus HQ recorded a FDA approval for MACLEODS PHARMS LTD, rated "info" severity in Argus HQ's classification: MACLEODS PHARMS LTD — ANDA approval: BUPROPION HYDROCHLORIDE (unspecified) An FDA approval record reflects FDA clearing a specific drug or biologic application for marketing. On 2026-07-01, Argus HQ recorded a FDA approval for MACLEODS PHARMS LTD, rated "info" severity in Argus HQ's classification: MACLEODS PHARMS LTD — ANDA approval: CHLORTHALIDONE (unspecified) An FDA approval record reflects FDA clearing a specific drug or biologic application for marketing. In total, MACLEODS PHARMS LTD has 3 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.
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. With 3 FDA events on file, there is not yet enough history in Argus HQ's database to describe a multi-event pattern beyond the single category involved. 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 MACLEODS PHARMS LTD had?
- Argus HQ has recorded 3 FDA events for MACLEODS PHARMS LTD: 0 warning letters, 0 recalls, 3 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 MACLEODS PHARMS LTD?
- The most recent FDA event Argus HQ has on file for MACLEODS PHARMS LTD is dated 2026-07-01, with a severity rating of "info" 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 PHARMS LTD 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 PHARMS LTD is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for MACLEODS PHARMS LTD?
- 3 total: 0 warning letters, 0 recalls, 3 approval records, and 0 Form 483 inspection citations.
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Related enforcement actions
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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). FDA Enforcement History: MACLEODS PHARMS LTD. Digital Empire LLC. Retrieved from https://argushq.ai/company/macleods-pharms-ltd
"FDA Enforcement History: MACLEODS PHARMS LTD." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/macleods-pharms-ltd.
Argus HQ Research. "FDA Enforcement History: MACLEODS PHARMS LTD." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/macleods-pharms-ltd.
@misc{argushq_argushq_ai_company_macleods_pharms_ltd_2026,
title = {FDA Enforcement History: MACLEODS PHARMS LTD},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/macleods-pharms-ltd},
note = {Accessed: July 13, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗