Astellas Pharma announced two urgent recalls for vital immunosuppressive drugs, Prograf and Astagraf XL, that are used to prevent organ rejection in transplant recipients.
The pharmaceutical company said some capsules in specific lots may be completely empty, posing a fatal risk to patients, reported the Daily Mail UK, who use these medications to maintain the delicate balance required to prevent the immune system from attacking transplanted organs.
Astagraf XL is given to patients after kidney transplants, Prograf is prescribed after kidney, heart, liver, or lung transplants.
Affected lots include Prograf 0.5 mg capsules (Lot No. 0E3353D) and Astagraf XL 0.5 mg capsules (Lot No. 0R3092A), both with a March 2026 expiration, said the Daily Mail UK.
Patients are advised to check the prescription label for an expiration date and to call their healthcare provider if they have the affected capsules.
Wholesalers and pharmacies should contact Astellas at 877-575-3437 and report issues to MedWatch, a program under the Food and Drug Administration (FDA) at 800-332-1088.
While Astellas Pharma issued its own recall, its unclear if the FDA will issue a recall or an investigation on quality control.
Currently the FDA is investigating Taylor Farms, a supplier of onions that were used in McDonald's Quarter Pounder burgers that caused a deadly E. coli outbreak in multiple states. Fast food chains such as Burger King and Taco Bell have responded by removing fresh onions from their menus.
