--- title: "Astellas Pharma US Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Astellas Pharma US Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/astellas-pharma-us-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Astellas Pharma US Inc. recall records **2** reported ongoing 3 records in this archive. Latest source date Dec 24, 2024. 1 published notices do not supply a closure status. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Dec 24, 2024 FDA company announcement ### [Astellas: Tacrolimus and Tacrolimus Extended-Release capsules](https://isitonrecall.com/recall/fdapress-709bad7a0dc5c11d-astellas-tacrolimus-and-tacrolimus-extended-release-capsules/) Bottles may contain empty capsules. Not supplied Published notice; closure not supplied Distribution: No other formulations or doses of the product are impacted, and sufficient supply of unaffected stock is available to replace the recalled lots. Product was distributed nationwi... [Official source for Astellas: Tacrolimus and Tacrolimus Extended-Release capsules](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) Dec 23, 2024 FDA drug enforcement ### [Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0...](https://isitonrecall.com/recall/fda-drug-d-0210-2025-astagraf-xl-tacrolimus-extended-release-capsules-0-5-mg-30-count-bottles-rx-only-product-of-japan-di/) Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules Class I Reported ongoing Distribution: Nationwide in the USA [Official source for Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0210-2025%22) Dec 23, 2024 FDA drug enforcement ### [Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.](https://isitonrecall.com/recall/fda-drug-d-0211-2025-prograf-tacrolimus-capsules-usp-0-5-mg-100-count-bottle-rx-only-product-of-japan-distributed-by-aste/) Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules Class I Reported ongoing Distribution: Nationwide in the USA [Official source for Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distribu...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0211-2025%22) ## Reasons in these listed records - Bottles may contain empty capsules. - Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules These examples come from this result page and are not a ranking of every recall reason. ## Checking Astellas Pharma US Inc. ### Is there a recall on astellas pharma us inc. right now? This archive contains 3 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Astellas Pharma US Inc.](https://isitonrecall.com/check/?q=Astellas%20Pharma%20US%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)