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# Astellas Recalls Lots of Prograf and Astagraf
- URL: https://www.fdaweb.com/astellas-recalls-lots-of-prograf-and-astagraf/
- Published: 2025-01-03T12:00:00.000Z
- Updated: 2026-09-14T14:50:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158390

FDA says Astellas Pharma has recalled one lot of Prograf 0.5 mg (tacrolimus) and one lot of Astagraf XL 0.5 mg (tacrolimus extended-release capsules) because some bottles shipped to the U.S. may contain empty capsules. The company [said](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/astellas-pharma-us-inc-issues-voluntary-nationwide-recall-one-lot-prografr-05mg-tacrolimus-and-one?ref=fdaweb.com) 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. Astellas had not received any reports of adverse events related to the recall, the notice said.