Astellas Tacrolimus and Tacrolimus Extended-Release capsules - recalled due to Bottles may contain empty capsules., USA

United States

Astellas Pharma US, Inc. is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules to the consumer level. These products are being recalled because bottles may contain empty capsules. The product was distributed nationwide to wholesale and retail outlets across the USA.

Risk Statement: Transplant patients who consume empty PROGRAF or ASTAGRAF XL capsules may experience initiation of rejection of the transplanted organ, tissue, or cells, due to underimmunosuppression. In the case of life-sustaining organ transplants such as a heart transplant (for which there is no permanent substitute such as hemodialysis in the case of a failed kidney transplant), if the transplant fails, the consequences of rejection initiated by ingesting empty capsules may be fatal. To date, Astellas has not received any reports of adverse events related to this recall.

PROGRAF and ASTAGRAF XL are immunosuppressive medicines, used in conjunction with other medicines, to help prevent organ transplant rejection. PROGRAF is used in people who have had kidney, heart, liver, or lung transplants, and ASTAGRAF XL is indicated for use in people with kidney transplants.

The affected lot numbers and expiration dates are:
- PROGRAF® (tacrolimus)
0.5 mg capsules
100 capsules per bottle
NDC: 0469-0607-73
LOT NO.: 0E3353D
EXP. DATE: 03/2026

- ASTAGRAF XL® (tacrolimus extended-release capsules)
0.5 mg capsules
30 capsules per bottle
NDC: 0469-0647-73
LOT NO.: 0R3092A
EXP. DATE: 03/2026

Patients who have an affected lot should not use it and return it for a full refund.

Company name: Astellas Pharma US, Inc.
Brand name: Astellas
Product recalled: Tacrolimus and Tacrolimus Extended-Release capsules
Reason of the recall: Bottles may contain empty capsules.
FDA Recall date: December 24, 2024