Organ Rejection Medications Recalled Over Empty Capsule Contamination

Astellas Pharma US Inc. has issued a Class I recall for both Astagraf XL (tacrolimus extended-release capsules) and Prograf (tacrolimus capsules) due to critical capsule specification failures. The affected Astagraf XL 0.5 mg capsules were distributed in 30-count bottles, totaling 3500 bottles nationwide, while the Prograf 0.5 mg capsules were distributed in 100-count bottles, with 14 340 bottles included in the recall. Both products, manufactured in Japan and distributed by Astellas Pharma from Northbrook, IL, may contain empty capsules, posing a serious health risk.

The recall was prompted by the discovery of empty capsules in both medications, compromising the integrity of proper dosing. Given the drugs’ narrow therapeutic window, the absence of active ingredients could lead to life-threatening consequences, particularly for patients relying on these medications to prevent organ rejection. Astellas voluntarily initiated the recall on December 23, 2024, issuing a press release and notifying consignees across the US. The recall status remains ongoing as of the latest US Food and Drug Administration (FDA) classification update on January 29, 2025.

Both Astagraf XL and Prograf are tacrolimus-based immunosuppressant therapies indicated for the prevention of organ rejection in kidney transplant recipients. Health care professionals and pharmacists should immediately inform patients and other stakeholders of the recall to prevent underdosing incidents. Monitoring and timely substitution of these critical medications are essential to ensure patient safety and transplant success.