What is the most recent FDA action on file for MYLAN PHARMACEUTICALS INC?

August 5, 2026. Argus HQ ingests new FDA enforcement records daily.

Has MYLAN PHARMACEUTICALS INC had product recalls?

Yes, 1 recall on file. See the full history below for each one.

Is this FDA enforcement data for MYLAN PHARMACEUTICALS INC 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 MYLAN PHARMACEUTICALS INC had?

Argus HQ has recorded 1 FDA events for MYLAN PHARMACEUTICALS INC: 0 warning letters, 1 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.

FDA Actions Against MYLAN PHARMACEUTICALS INC

Here's the summary: Argus HQ has recorded 1 FDA events for MYLAN PHARMACEUTICALS INC: 0 warning letters, 1 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-08-05 to 2026-08-05. The most severe rating Argus HQ has assigned across this history is "high". 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.

FDA action counts

Total FDA actions	1
Warning letters	0
Recalls	1
Approval records	0
Form 483 inspection citations	0
Most recent action	August 5, 2026

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. MYLAN PHARMACEUTICALS INC 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 2026-08-05, Argus HQ recorded an FDA recall for MYLAN PHARMACEUTICALS INC, rated "high" severity in Argus HQ's classification: MYLAN PHARMACEUTICALS INC — Class II recall: Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials…. 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 on file for MYLAN PHARMACEUTICALS INC?: August 5, 2026. Argus HQ ingests new FDA enforcement records daily.
Has MYLAN PHARMACEUTICALS INC had product recalls?: Yes, 1 recall on file. See the full history below for each one.
Is this FDA enforcement data for MYLAN PHARMACEUTICALS INC 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 MYLAN PHARMACEUTICALS INC had?: Argus HQ has recorded 1 FDA events for MYLAN PHARMACEUTICALS INC: 0 warning letters, 1 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.

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MYLAN PHARMACEUTICALS INC — Class II recall: Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials… →

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

Verified from FDA.gov · Last updated: Aug 5, 2026

Cite this record

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

APA

Argus HQ Research (2026). FDA Actions Against MYLAN PHARMACEUTICALS INC. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/mylan-pharmaceuticals-inc

MLA

"FDA Actions Against MYLAN PHARMACEUTICALS INC." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/mylan-pharmaceuticals-inc.

Chicago

Argus HQ Research. "FDA Actions Against MYLAN PHARMACEUTICALS INC." Digital Empire Holdings LLC. Accessed August 13, 2026. https://argushq.ai/company/mylan-pharmaceuticals-inc.

BibTeX

@misc{argushq_argushq_ai_company_mylan_pharmaceuticals_inc_2026,
  title = {FDA Actions Against MYLAN PHARMACEUTICALS INC},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/mylan-pharmaceuticals-inc},
  note = {Accessed: August 13, 2026}
}

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