On September 11, 2023, the U.S. Food and Drug Administration announced Novartis’s voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/ml, in the United States because of observations of crystals in some bottles that could result in incorrect dosing. No other cyclosporine oral solution formulations are affected.

FDA update

Cyclosporine oral solution 100 mg/ml, packaged in 50 ml bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

Novartis said that crystallization is likely to result in nonuniform distribution of the cyclosporine in the product, resulting in under- or overdosing. According to the company, underdosing may result in lower exposures and decrease in efficacy, which could ultimately lead to graft rejection and graft loss in transplant recipients. Overdosing may lead to cyclosporine toxicity with long-term overexposure. To date, Novartis has not received any reports of adverse events related to the recall.

The affected lot is FX001691 (expiration date 12/2025), which was distributed nationwide to wholesalers beginning in April 2023.

Novartis notified distributors via a recall notification letter and is arranging for distributors, retailers, and consumers to return the recalled lot. Novartis also notified healthcare providers who prescribed the product to contact their patients. Consumers who have bottles from the recalled lot should contact their healthcare provider.

Patients who experience an adverse reaction or quality problem involving the product should immediately contact their healthcare provider and Novartis to report the event or finding. Patients or healthcare providers may call the Novartis customer interaction center at 888-NOW-NOVA (888-669-6682) from 8:30 am–5 pm ET, Monday–Friday, or may report an adverse event online or by email to usdrugsafety.operations@novartis.com.

Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.