FDA action counts
| Total FDA actions | 1 |
|---|---|
| Warning letters | 0 |
| Recalls | 1 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | October 22, 2025 |
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. ASTRAZENECA 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 2025-10-22, Argus HQ recorded an FDA recall for ASTRAZENECA PHARMACEUTICALS, rated "high" severity in Argus HQ's classification: ASTRAZENECA PHARMACEUTICALS — Class II recall: Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe,…. 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
- Does Argus HQ track new FDA actions for ASTRAZENECA 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 ASTRAZENECA PHARMACEUTICALS is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for ASTRAZENECA 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 ASTRAZENECA PHARMACEUTICALS?
- October 22, 2025. Argus HQ ingests new FDA enforcement records daily.
- Has ASTRAZENECA PHARMACEUTICALS had product recalls?
- Yes, 1 recall on file. See the full history below for each one.
Every FDA action tied to this company, the week it happens.
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Related enforcement actions
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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Oct 22, 2025Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2025). ASTRAZENECA PHARMACEUTICALS's Complete FDA Record. Digital Empire LLC. Retrieved from https://argushq.ai/company/astrazeneca-pharmaceuticals
"ASTRAZENECA PHARMACEUTICALS's Complete FDA Record." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/company/astrazeneca-pharmaceuticals.
Argus HQ Research. "ASTRAZENECA PHARMACEUTICALS's Complete FDA Record." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/company/astrazeneca-pharmaceuticals.
@misc{argushq_argushq_ai_company_astrazeneca_pharmaceuticals_2025,
title = {ASTRAZENECA PHARMACEUTICALS's Complete FDA Record},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/astrazeneca-pharmaceuticals},
note = {Accessed: July 17, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗

