What is the most recent FDA action against Sagent Pharmaceuticals?

The most recent FDA event Argus HQ has on file for Sagent Pharmaceuticals is dated 2026-05-27, 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 Sagent Pharmaceuticals 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 Sagent Pharmaceuticals is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Sagent Pharmaceuticals?

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 Sagent Pharmaceuticals?

May 27, 2026. Argus HQ ingests new FDA enforcement records daily.

FDA Actions Against Sagent Pharmaceuticals

Here's the summary: Argus HQ has recorded 1 FDA events for Sagent Pharmaceuticals: 0 warning letters, 1 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-05-27 to 2026-05-27. 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.

FDA action counts

Total FDA actions	1
Warning letters	0
Recalls	1
Approval records	0
Form 483 inspection citations	0
Most recent action	May 27, 2026

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Sagent Pharmaceuticals 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 2026-05-27, Argus HQ recorded an FDA recall for Sagent Pharmaceuticals, rated "medium" severity in Argus HQ's classification: Sagent Pharmaceuticals — Class III recall: Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx…. 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 Sagent Pharmaceuticals?: The most recent FDA event Argus HQ has on file for Sagent Pharmaceuticals is dated 2026-05-27, 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 Sagent Pharmaceuticals 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 Sagent Pharmaceuticals is observed, this page's event count and history update automatically.
How many FDA actions does Argus HQ track for Sagent Pharmaceuticals?: 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 Sagent Pharmaceuticals?: May 27, 2026. Argus HQ ingests new FDA enforcement records daily.

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Sagent Pharmaceuticals — Class III recall: Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx… →

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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.

APA

Argus HQ Research (2026). FDA Actions Against Sagent Pharmaceuticals. Digital Empire LLC. Retrieved from https://argushq.ai/company/sagent-pharmaceuticals

MLA

"FDA Actions Against Sagent Pharmaceuticals." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/sagent-pharmaceuticals.

Chicago

Argus HQ Research. "FDA Actions Against Sagent Pharmaceuticals." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/sagent-pharmaceuticals.

BibTeX

@misc{argushq_argushq_ai_company_sagent_pharmaceuticals_2026,
  title = {FDA Actions Against Sagent Pharmaceuticals},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/sagent-pharmaceuticals},
  note = {Accessed: July 13, 2026}
}

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