Medications & Supplements/Prescription Drugs

Sandimmune (cyclosporine) Oral Solution Recalled for Crystallization

Agency Publication Date: September 21, 2023

Summary

Novartis Pharmaceuticals Corp. is recalling approximately 1,272 bottles of Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL. The recall was issued after crystals were found to have formed within the liquid medication. If you or someone in your care uses this medication, you should consult with a healthcare provider or pharmacist to discuss your treatment.

Risk

The formation of crystals in the solution can cause the medication to be distributed unevenly, which may lead to a patient receiving too little or too much of the drug. For patients taking cyclosporine to prevent organ transplant rejection, inconsistent dosing can lead to serious health issues, including organ rejection or medication toxicity.

What You Should Do

This recall affects Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, which is packaged in 50 mL bottles labeled with NDC 0078-0110-22.
Identify the affected product by checking the label for lot number FX001691 and an expiration date of 12/31/2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Novartis Pharmaceuticals Corp. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sandimmune Oral Solution (cyclosporine oral solution, USP)

Variants: 100 mg/mL, 50 mL bottle

Lot Numbers:

FX001691 (Exp. 12/31/2025)

NDC:

0078-0110-22

Quantity affected: 1,272 bottles.

Product Images

“Carton Label, Sandimunne, Oral Solution, (Cyclosporine oral solution, USP) 100 mg/mL”

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92975

Status: Active

Manufacturer: Novartis Pharmaceuticals Corp.

Sold By: Pharmacies

Manufactured In: France

Units Affected: 1272 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, which is packaged in 50 mL bottles labeled with NDC 0078-0110-22.

Identify the affected product by checking the label for lot number FX001691 and an expiration date of 12/31/2025.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Novartis Pharmaceuticals Corp. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.