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# Novartis Recalls Sandimmune Lot
- URL: https://www.fdaweb.com/novartis-recalls-sandimmune-lot/
- Published: 2023-09-11T12:00:00.000Z
- Updated: 2026-09-14T18:55:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155298

Novartis has recalled one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/ml due to crystal formation observed in some bottles, which could affect dosing. The drug is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The affected lot number is FX001691 (expiration date 12/2025).

“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,” a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-nationwide-recall-one-lot-sandimmuner-oral-solution-cyclosporine-oral?ref=fdaweb.com) says. “There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients.”