How many FDA actions has Amgen, Inc. had?

Argus HQ has recorded 5 FDA events for Amgen, Inc.: 0 warning letters, 5 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 Amgen, Inc.?

The most recent FDA event Argus HQ has on file for Amgen, Inc. is dated 2026-07-01, 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 Amgen, Inc. 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 Amgen, Inc. is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Amgen, Inc.?

5 total: 0 warning letters, 5 recalls, 0 approval records, and 0 Form 483 inspection citations.

FDA Enforcement History: Amgen, Inc.

Argus HQ has recorded 5 FDA events for Amgen, Inc.: 0 warning letters, 5 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-07-01 to 2026-07-01. 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.

FDA action counts

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

Enforcement history

On 2026-07-01, Argus HQ recorded a FDA recall for Amgen, Inc., rated "high" severity in Argus HQ's classification: Amgen, Inc. — Class II recall: Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Tho… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Amgen, Inc., rated "high" severity in Argus HQ's classification: Amgen, Inc. — Class II recall: Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by:… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Amgen, Inc., rated "high" severity in Argus HQ's classification: Amgen, Inc. — Class II recall: Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by:… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Amgen, Inc., rated "high" severity in Argus HQ's classification: Amgen, Inc. — Class II recall: Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 5551… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Amgen, Inc., rated "high" severity in Argus HQ's classification: Amgen, Inc. — Class II recall: Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by:… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Amgen, Inc. has 5 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).

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Amgen, Inc. has 5 separate FDA recalls on file, more than a single isolated recall event. 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.

Frequently asked questions

How many FDA actions has Amgen, Inc. had?: Argus HQ has recorded 5 FDA events for Amgen, Inc.: 0 warning letters, 5 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 Amgen, Inc.?: The most recent FDA event Argus HQ has on file for Amgen, Inc. is dated 2026-07-01, 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 Amgen, Inc. 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 Amgen, Inc. is observed, this page's event count and history update automatically.
How many FDA actions does Argus HQ track for Amgen, Inc.?: 5 total: 0 warning letters, 5 recalls, 0 approval records, and 0 Form 483 inspection citations.

Every FDA action tied to this company, the week it happens.

Free weekly briefing. Real-time alerts on paid plans.

Compare with

Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai

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 Enforcement History: Amgen, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/company/amgen-inc

MLA

"FDA Enforcement History: Amgen, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/amgen-inc.

Chicago

Argus HQ Research. "FDA Enforcement History: Amgen, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/amgen-inc.

BibTeX

@misc{argushq_argushq_ai_company_amgen_inc_2026,
  title = {FDA Enforcement History: Amgen, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/amgen-inc},
  note = {Accessed: July 13, 2026}
}

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