Novartis controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2026
Novartis recalls Diovan valsartan batch over dissolution specification failure
Recall announced
Novartis recalled a specific batch of its Diovan (valsartan) blood pressure drug after it failed to meet dissolution specifications, potentially reducing effectiveness. The FDA classified the notice as a Class II recall, warning of possible temporary or medically reversible adverse health consequences. The affected batch, marked AV5913C, consists of 90-count 160-mg tablets expiring June 2027, manufactured by Pantheon Manufacturing Services in Greenville, North Carolina and distributed nationwide in the US.
Company response
Recall — Novartis
Novartis made the recall on August 4.
Source excerpt
The batch that is being recalled has AV5913C on the packaging and include packages of 90 160-mg tablets with an expiration date of June 2027.
The valsartan drug was made by Novartis under the brand name Diovan and has been recalled as it does not meet dissolution specifications.
The US Food and Drug Administration has determined the notice as a Class II recall, which means exposure to the drug may lead to “temporary or medically reversible adverse health consequences.”
2020
Novartis recalled Sandimmune and Neoral 100 mg blister packages
Recall announced
Novartis recalled specified 100 mg Sandimmune and Neoral prescription drug blister packages because the packaging did not meet child-resistant requirements, posing a poisoning risk if young children swallowed the contents. No incidents or injuries were reported. Consumers were advised to secure the products and contact the firm for a free child-resistant pouch.
Source excerpt
Name of Product: Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages
Distributor: Novartis Pharmaceuticals Corporation, of East Hanover, N.J.
WASHINGTON, March 18, 2020 /PRNewswire/ -- https://cpsc.gov/Recalls/2020/Novartis-Recalls-100-mg-Sandimmune-and-Neoral-Prescription-Drug-Blister-Packages-Due-to-Failure-to-Meet-ChildResistant-Packaging-Requirement-Risk-of-Poisoning
2020
Novartis agrees to settle U.S. fraud lawsuit
Settlement
Novartis agreed to pay $678 million to settle a civil fraud lawsuit. The U.S. government accused the company of illegally providing doctors with cash payments and other perks to induce them to prescribe its drugs; the settlement resolves charges under the False Claims Act and an anti-kickback statute.
Company response
Refund or compensation — Novartis
Novartis has agreed to pay $678 million to settle a civil fraud lawsuit.
Source excerpt
The U.S. government accused the Swiss drugmaker of illegally providing doctors with cash payments and other perks to induce them to prescribe its cardiovascular and diabetes drugs.
Novartis has agreed to pay $678 million to settle a civil fraud lawsuit.
The U.S. Department of Justice announced the settlement late on Wednesday to resolve charges that Novartis violated the federal False Claims Act and an anti-kickback statute.
2020
Federal Court fines GSK and Novartis over Osteo Gel marketing
Fine or penalty
The Federal Court ordered GlaxoSmithKline to pay $1.5 million and Novartis to pay $3 million after the companies admitted breaching Australian consumer law through their marketing of Osteo Gel between 2012 and 2017. The court found that the marketing misled consumers about the product's effectiveness compared with Emulgel.
Company response
Apology — GSK
In an affidavit, GSK's head of legal Navaneetha Dilipumakanth apologised for the company's conduct and admitted it had "fallen short of the standards expected of it under the Australian Consumer Law".
Apology — GSK
In an affidavit, GSK's head of legal Navaneetha Dilipumakanth apologised for the company's conduct
Source excerpt
GSK and Novartis admitted they had breached Australian consumer law with their marketing of Osteo Gel between 2012 and 2017.
In an affidavit, GSK's head of legal Navaneetha Dilipumakanth apologised for the company's conduct and admitted it had "fallen short of the standards expected of it under the Australian Consumer Law".
The parties also agreed on the question of penalties and Federal Court Justice Robert Bromwich today ordered GSK pay a fine of $1.5 million and Novartis pay $3 million.
2013
United States allegations concerning payments to doctors
The United States government brought litigation alleging that Novartis used improper payments and other inducements over an extended period to influence prescribing. The allegations concerned commercial conduct and compliance with healthcare-marketing rules.
1990
Toms River contamination controversy
A former Ciba-Geigy chemical plant in Toms River, New Jersey, was associated with groundwater contamination and investigations into elevated childhood cancer incidence. The site became a United States Superfund location; later monitoring reported improved conditions and continuing water testing.
1986
Sandoz chemical spill
A fire at a Sandoz storage facility near Basel caused pesticide-contaminated water to enter the Rhine, killing substantial aquatic life and prompting major environmental criticism and regulatory scrutiny. The incident predates Novartis but forms part of the corporate history inherited through the Sandoz merger.