Drug recall: Sandimmune Oral Solution Voluntary Recalled: Novartis

It's important to note that the drug recall is limited to the consumer level and does not affect any other formulations of Sandimmune.

Drug product Recall
Drug Recall

Drug recall

Novartis, a renowned pharmaceutical company, has recently initiated a voluntary drug recall of two lots of its 100mg/mL Sandimmune oral solution (cyclosporine oral solution, USP) in the United States due to reported crystallisation issues in some bottles.

Reasons Behind the Drug Recall

Drug Recall FDA
Picture: Pixabay

The drug recall stems from concerns about crystal formation, which could lead to incorrect dosages being administered to patients.

This is a critical issue as the proper dosage is paramount in ensuring the efficacy of the medication.

Impact on Dosages

Crystallisation of cyclosporine in the Sandimmune oral solution may result in non-uniform distribution of the drug in the product.

This poses a significant risk of under-dosing or over-dosing, both of which can have severe consequences for patients.

Scope of the Drug Recall

It’s important to note that the drug recall is limited to the consumer level and does not affect any other formulations of Sandimmune.

Distributors and healthcare providers are actively being notified to prevent further distribution of the affected lots.

Notification to Distributors and Healthcare Providers

In response to the issue, Novartis is taking proactive measures to inform distributors and healthcare providers about the drug recall.

This ensures that the affected lots are swiftly removed from circulation, preventing potential harm to patients.

Product Details

The Sandimmune oral solution, available in 50mL bottles, is primarily used for the prophylaxis of organ rejection in patients with allogeneic liver, kidney, and heart transplants.

Additionally, it can be employed for chronic rejection in patients who have already received immunosuppressive agents.

Concerns About Crystallisation

The company has highlighted the risk associated with cyclosporine crystallisation. This occurrence could result in the uneven distribution of the drug, compromising its effectiveness.

Potential Health Risks

Novartis has underscored the potential health risks associated with incorrect dosages.

Under-dosing may lead to lower exposures and decreased efficacy, ultimately increasing the risk of graft rejection and loss in transplant patients.

Conversely, over-dosing may result in long-term cyclosporine toxicity.

Absence of Reported Adverse Events

As of now, Novartis has not received any reports of drug-linked adverse events associated with the recalled lots.

However, the company is urging consumers with bottles from the affected lots to contact their healthcare providers promptly.

Consumer Action

For individuals who possess bottles from the recalled lots, it is crucial to reach out to their healthcare providers.

Prompt communication with healthcare professionals will facilitate the necessary steps to address potential issues arising from the drug recall.

Previous Recalls by Novartis

This recent drug recall follows a similar action taken by Novartis in September 2023 when another lot of 100mg/mL Sandimmune Oral Solution was recalled for the same reason.

This pattern underscores the company’s commitment to ensuring the safety and efficacy of its products.

Company Response

Novartis is actively addressing the situation by recalling the affected lots and communicating transparently about the issue.

The company’s swift response demonstrates its dedication to patient safety and regulatory compliance.

Ensuring Drug Safety

The incident raises broader questions about the pharmaceutical industry’s responsibility in ensuring the safety of its products.

It highlights the need for rigorous quality control measures to prevent issues that could potentially harm patients.

The Impact on Transplant Patients

Transplant patients, who rely on medications like Sandimmune to prevent organ rejection, are particularly vulnerable to dosage inaccuracies.

The potential consequences underscore the importance of pharmaceutical companies maintaining the highest standards in manufacturing and distribution.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.


  1. Q: How do I know if my Sandimmune oral solution is from the recalled lots?
    • A: Check the lot number on the bottle and compare it to the information provided by Novartis. If in doubt, contact your healthcare provider.
  2. Q: What should I do if I have a bottle from the recalled lots?
    • A: Reach out to your healthcare provider immediately for guidance and potential replacement.
  3. Q: Are there alternative medications available for transplant patients during the recall?
    • A: Your healthcare provider will guide you on suitable alternatives based on your medical history and condition.
  4. Q: Has Novartis provided any compensation or assistance for affected consumers?
    • A: Details about compensation or assistance can be obtained by contacting Novartis directly or through your healthcare provider.
  5. Q: How often does Novartis conduct quality checks on its pharmaceutical products?
    • A: Novartis follows rigorous quality control measures, but specific timelines for checks may vary. The company is committed to continuous improvement in its processes.

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