How many FDA warning letters has NOVARTIS received?

Argus HQ has not recorded an FDA warning letter for NOVARTIS in our current dataset.

What FDA recalls has NOVARTIS issued?

Argus HQ has recorded 1 FDA recall tied to NOVARTIS.

Is NOVARTIS FDA compliant?

Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 3 approval records for NOVARTIS. Review the linked FDA source records directly before drawing a compliance conclusion.

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company

NOVARTIS

Name: FDA Enforcement Actions Against NOVARTIS
Creator: Argus HQ
License: https://argushq.ai/methodology

Jurisdiction: US

FDA Warning Letter timeline

V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.

fda_approval · anda2026-07-01
SANDOZ — ANDA approval: LIRAGLUTIDE (unspecified)
fda_approval · nda2026-07-01
NOVARTIS — NDA approval: KISQALI (unspecified)
fda_approval · nda2026-07-01
NOVARTIS — NDA approval: KISQALI FEMARA CO-PACK (COPACKAGED) (unspecified)
fda_recall · drug_recall2026-06-24
Sandoz Inc — Class III recall: Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottl…

Frequently asked questions

How many FDA warning letters has NOVARTIS received?: Argus HQ has not recorded an FDA warning letter for NOVARTIS in our current dataset.
What FDA recalls has NOVARTIS issued?: Argus HQ has recorded 1 FDA recall tied to NOVARTIS.
Is NOVARTIS FDA compliant?: Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 3 approval records for NOVARTIS. Review the linked FDA source records directly before drawing a compliance conclusion.

Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.