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# Novartis Recalls 2 Sandimmune Lots
- URL: https://www.fdaweb.com/novartis-recalls-2-sandimmune-lots/
- Published: 2023-11-27T12:00:00.000Z
- Updated: 2026-09-14T14:16:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155857

Novartis has recalled two lots of its Sandimmune oral solution (cyclosporine) 100 mg/mL due to crystal formation observed in some bottles, which could result in incorrect dosing. The issue was identified during an investigation of crystallization in a different Sandimmune lot, according to a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-us-nationwide-recall-two-lots-sandimmuner-oral-solution-cyclosporine-oral?utm%5Fmedium=email&utm%5Fsource=govdelivery). The drug is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.

“Crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing,” the notice says. “There is a reasonable probability that under-dosing may result in lower exposures and a decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients. Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if overexposure continues.”

Novartis says it has not received any adverse event reports related to the recall.