Astellas Pharma US, Inc. has issued a recall for one lot of PROGRAF 0.5mg (tacrolimus) and one lot of ASTAGRAF XL 0.5mg (tacrolimus extended-release) capsules. These products are being recalled because the bottles may contain empty capsules.
Transplant patients who consume empty PROGRAF or ASTAGRAF XL capsules may experience 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. 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:
PRODUCT DESCRIPTION | NDC | LOT NO. | EXP. DATE |
PROGRAF® (tacrolimus) | 0469-0607-73 | 0E3353D | 03/2026 |
ASTAGRAF XL® (tacrolimus extended- | 0469-0647-73 | 0R3092A | 03/2026 |
No other formulations or doses of the product are impacted, and sufficient supply of unaffected stock is available to replace the recalled lots. The product was distributed nationwide to wholesale and retail outlets.
What to do
Astellas is notifying its customers via a drug recall notification letter and is arranging for the return of the impacted product. Wholesalers or pharmacists with questions about the recall process should contact 1-877-575-3437 during office hours 9 am to 5 pm EST, Monday through Friday.
Patients who have an affected lot should contact their physician or healthcare provider. Patients and physicians with questions should contact Astellas Medical Information at 1-800-727-7003 During office hours from 9 am to 5:30 pm EST, Monday through Friday.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.