Astellas Pharma US, Inc., a leading name in life sciences, has announced a voluntary recall of one lot of Prograf® 0.5mg (tacrolimus) and one lot of Astagraf XL® 0.5mg (tacrolimus extended-release) capsules. 

The recall, conducted at the consumer level, was initiated after reports indicated that bottles might contain empty capsules. This precautionary measure reflects Astellas’ commitment to ensuring patient safety and product quality.

Prograf and Astagraf XL are immunosuppressive medications prescribed to organ transplant recipients to prevent rejection. Any disruption in their effectiveness, such as the presence of empty capsules, poses a significant risk. Transplant patients who unknowingly consume empty capsules could experience underimmunosuppression, leading to organ rejection. For patients relying on life-sustaining organ transplants, such as heart transplants, the consequences could be fatal. While Astellas has confirmed that no adverse events have been reported so far, the recall underscores the gravity of the potential risk.

The affected medications are from specific lots with expiration dates in March 2026. Prograf® 0.5mg capsules (Lot No. 0E3353D) and Astagraf XL® 0.5mg capsules (Lot No. 0R3092A) were distributed nationwide to wholesale and retail outlets. Other formulations and dosages of these medications remain unaffected, and sufficient stock of unaffected products is available to ensure uninterrupted patient care.

Astellas is actively notifying its customers about the recall through official communication channels and arranging for the return of the impacted products. Patients who believe they have received the affected medication are urged to contact their healthcare provider immediately for further guidance. Physicians and pharmacists can reach Astellas Medical Information for assistance.

The U.S. Food and Drug Administration (FDA) is overseeing the recall process. Patients and healthcare providers are encouraged to report any adverse reactions or quality issues to the FDA’s MedWatch Adverse Event Reporting program.

Astellas Pharma, renowned for its contributions to healthcare innovation, has reiterated its commitment to delivering transformative therapies in areas such as oncology, immunology, and women’s health. The company’s prompt action in recalling the affected products reflects its focus on maintaining patient trust and safety.

For more information on Astellas Pharma and its healthcare initiatives, patients and providers can visit the company’s official website. The recall highlights the critical importance of rigorous quality control measures in the pharmaceutical industry to safeguard public health.