Has Novartis Pharmaceuticals Corp. had product recalls?

Yes, 1 recall on file. See the full history below for each one.

Is this FDA enforcement data for Novartis Pharmaceuticals Corp. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Novartis Pharmaceuticals Corp. had?

Argus HQ has recorded 1 FDA events for Novartis Pharmaceuticals Corp.: 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 Novartis Pharmaceuticals Corp.?

The most recent FDA event Argus HQ has on file for Novartis Pharmaceuticals Corp. is dated 2023-09-27, with a severity rating of "critical" 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.

Regulatory Record: Novartis Pharmaceuticals Corp.

FDA action counts

Total FDA actions	1
Warning letters	0
Recalls	1
Approval records	0
Form 483 inspection citations	0
Most recent action	September 27, 2023

The short version: Argus HQ has recorded 1 FDA events for Novartis Pharmaceuticals Corp.: 0 warning letters, 1 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2023-09-27 to 2023-09-27. The most severe rating Argus HQ has assigned across this history is "critical". 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. Novartis Pharmaceuticals Corp. 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 2023-09-27, Argus HQ recorded an FDA recall for Novartis Pharmaceuticals Corp., rated "critical" severity in Argus HQ's classification: Novartis Pharmaceuticals Corp. — Class I recall: SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bott…. 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

Has Novartis Pharmaceuticals Corp. had product recalls?: Yes, 1 recall on file. See the full history below for each one.
Is this FDA enforcement data for Novartis Pharmaceuticals Corp. official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has Novartis Pharmaceuticals Corp. had?: Argus HQ has recorded 1 FDA events for Novartis Pharmaceuticals Corp.: 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 Novartis Pharmaceuticals Corp.?: The most recent FDA event Argus HQ has on file for Novartis Pharmaceuticals Corp. is dated 2023-09-27, with a severity rating of "critical" 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.

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Novartis Pharmaceuticals Corp. — Class I recall: SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bott… →

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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 27, 2023

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2023). Regulatory Record: Novartis Pharmaceuticals Corp.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/novartis-pharmaceuticals-corp

MLA

"Regulatory Record: Novartis Pharmaceuticals Corp.." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/company/novartis-pharmaceuticals-corp.

Chicago

Argus HQ Research. "Regulatory Record: Novartis Pharmaceuticals Corp.." Digital Empire Holdings LLC. Accessed July 17, 2026. https://argushq.ai/company/novartis-pharmaceuticals-corp.

BibTeX

@misc{argushq_argushq_ai_company_novartis_pharmaceuticals_corp_2023,
  title = {Regulatory Record: Novartis Pharmaceuticals Corp.},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/novartis-pharmaceuticals-corp},
  note = {Accessed: July 17, 2026}
}

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