How many FDA actions has Amneal Pharmaceuticals of New York, LLC had?

Argus HQ has recorded 1 FDA events for Amneal Pharmaceuticals of New York, LLC: 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.

What is the most recent FDA action against Amneal Pharmaceuticals of New York, LLC?

The most recent FDA event Argus HQ has on file for Amneal Pharmaceuticals of New York, LLC is dated 2026-09-30, with a severity rating of "high" 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 Amneal Pharmaceuticals of New York, 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 Amneal Pharmaceuticals of New York, LLC is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Amneal Pharmaceuticals of New York, LLC?

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

Amneal Pharmaceuticals of New York, LLC — 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 Amneal Pharmaceuticals of New York, LLC: 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 "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.

Enforcement history

On 2026-09-30, Argus HQ recorded an FDA recall for Amneal Pharmaceuticals of New York, LLC, rated "high" severity in Argus HQ's classification: Amneal Pharmaceuticals of New York, LLC — Class II recall: Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcuta…. 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. Amneal Pharmaceuticals of New York, LLC 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.

Frequently asked questions

How many FDA actions has Amneal Pharmaceuticals of New York, LLC had?: Argus HQ has recorded 1 FDA events for Amneal Pharmaceuticals of New York, LLC: 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.
What is the most recent FDA action against Amneal Pharmaceuticals of New York, LLC?: The most recent FDA event Argus HQ has on file for Amneal Pharmaceuticals of New York, LLC is dated 2026-09-30, with a severity rating of "high" 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 Amneal Pharmaceuticals of New York, 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 Amneal Pharmaceuticals of New York, LLC is observed, this page's event count and history update automatically.
How many FDA actions does Argus HQ track for Amneal Pharmaceuticals of New York, LLC?: 1 total: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

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Amneal Pharmaceuticals of New York, LLC — Class II recall: Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcuta… →

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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). Amneal Pharmaceuticals of New York, LLC — FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/amneal-pharmaceuticals-of-new-york-llc

MLA

"Amneal Pharmaceuticals of New York, LLC — FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/amneal-pharmaceuticals-of-new-york-llc.

Chicago

Argus HQ Research. "Amneal Pharmaceuticals of New York, LLC — FDA Enforcement History." Digital Empire Holdings LLC. Accessed October 12, 2026. https://argushq.ai/company/amneal-pharmaceuticals-of-new-york-llc.

BibTeX

@misc{argushq_argushq_ai_company_amneal_pharmaceuticals_of_new_york_llc_2026,
  title = {Amneal Pharmaceuticals of New York, LLC — FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/amneal-pharmaceuticals-of-new-york-llc},
  note = {Accessed: October 12, 2026}
}

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