FDA action counts (Argus HQ database)
| Total tracked FDA actions | 7 |
|---|---|
| Recalls | 7 |
| Warning letters | 0 |
| Form 483 inspection citations | 0 |
| Most recent tracked action | July 1, 2026 |
| Most severe rating on file | high |
Recall severity breakdown
Computed from all 7 tracked recalls. FDA classifies each recall Class I (most serious), II, or III on the underlying record; Argus HQ maps that to critical/high/medium/low severity buckets.
| high | 7 (100.0%) |
|---|
Recall velocity by month
Months with at least one tracked recall for Amgen, Inc., oldest to most recent. Gaps indicate months with zero tracked recalls, not missing data.
| Month | Recalls |
|---|---|
| 2025-03 | 2 |
| 2026-07 | 5 |
Recurring recall-reason patterns
Argus HQ keyword-matched the free-text “reason for recall” field on each tracked record into categories below. FDA does not publish a structured reason code for device recalls, so this is Argus HQ’s own pattern analysis, not an official FDA classification — records that don’t match a listed keyword fall into “Other.”
| Other / not pattern-matched | 7 recalls |
|---|
Full recall history (7)
Most recent first. Every row links to its Argus HQ record and FDA.gov source.
Coverage
No independent news coverage was found for Amgen, Inc.’s FDA recall history at the time this page was published — its enforcement record is small enough that it hasn’t drawn trade-press attention. This page is the most complete public record available.
Every FDA action tied to this company, the week it happens.
Free weekly briefing. Real-time alerts on paid plans.
Related enforcement actions
Full FDA history for Amgen, Inc.- Amgen, Inc. — Class II recall: Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by:… →
- Amgen, Inc. — Class II recall: Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 5551… →
- Amgen, Inc. — Class II recall: Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by:… →
- Amgen, Inc. — Class II recall: Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by:… →
- Amgen, Inc. — Class II recall: Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Tho… →
- Amgen, Inc. — Class II recall: Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Onl… →
- Amgen, Inc. — Class II recall: Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL singl… →
Other enforcement deep dives
- Wisconsin Pharmacal Company: FDA enforcement history →
- Philips North America: FDA enforcement history →
- Boston Scientific Corporation: FDA enforcement history →
- Medline Industries, LP: FDA enforcement history →
- Baxter Healthcare Corporation: FDA enforcement history →
- Philips Medical Systems Nederland B.V.: FDA enforcement history →
- Becton Dickinson & Company: FDA enforcement history →
- Zimmer, Inc.: FDA enforcement history →
- ARROW International, LLC: FDA enforcement history →
- Medtronic Perfusion Systems: FDA enforcement history →
- Stryker Sustainability Solutions: FDA enforcement history →
- B. Braun Medical Inc.: FDA enforcement history →
- Fresenius Kabi USA, LLC: FDA enforcement history →
- CareFusion 213, LLC: FDA enforcement history →
- Windstone Medical Packaging, Inc.: FDA enforcement history →
- Siemens Medical Solutions USA, Inc.: FDA enforcement history →
- GE Medical Systems, LLC: FDA enforcement history →
- Olympus Corporation of the Americas: FDA enforcement history →
- Abiomed, Inc.: FDA enforcement history →
- Dabur India Limited: FDA enforcement history →
- AVID Medical, Inc.: FDA enforcement history →
- DePuy (Ireland): FDA enforcement history →
- Wells Pharma of Houston LLC: FDA enforcement history →
- GE Medical Systems Information Technologies Inc: FDA enforcement history →
- Elekta, Inc.: FDA enforcement history →
- Covidien LLC: FDA enforcement history →
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Jul 1, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Amgen, Inc.: FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/enforcement/amgen-inc
"Amgen, Inc.: FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/enforcement/amgen-inc.
Argus HQ Research. "Amgen, Inc.: FDA Enforcement History." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/enforcement/amgen-inc.
@misc{argushq_argushq_ai_enforcement_amgen_inc_2026,
title = {Amgen, Inc.: FDA Enforcement History},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/enforcement/amgen-inc},
note = {Accessed: July 24, 2026}
}