Class I Recall for Immunosuppressant

A Class I recall has been issued for a single lot of Sandimmune Oral Solution (cyclosporine oral solution) because of product crystallization and the subsequent potential for incorrect cyclosporine dosing. The recall appeared in the September 27, 2023, US Food and Drug Administration (FDA) Enforcement Report.

Sandimmune Oral Solution is a prescription medication indicated for the prophylaxis of organ rejection in patients who received kidney, liver, and heart allogeneic transplants. It also can be used to treat chronic rejection in patients previously treated with other immunosuppressive agents.

The FDA’s most significant recall classification, a Class I designation warns use of the affected drug could cause serious adverse health consequences or death.

“Crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in nonuniform distribution of the cyclosporine in the product, resulting in underdosing or overdosing,” recalling firm Novartis Pharmaceuticals Corporation stated in a September 11, 2023, announcement. “There is a reasonable probability that underdosing may result in lower exposures and decrease in efficacy, which could ultimately lead to graft rejection and graft loss in transplant patients. Furthermore, overdosage may manifest itself as cyclosporine toxicity in the long term if overexposure continues.”

The recall affects Sandimmune Oral Solution, 100 mg/mL, in 50-mL bottles (NDC 0078-0110-22), from lot FX001691 (Exp. 12/31/25). The product was manufactured by Delpharm Huningue SAS, Huningue, France, and distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, throughout the US beginning in April 2023.