Astellas recalls Prograf (tacrolimus) capsules due to potential empty capsules in some shipments. This may cause medication failure for immunosuppressant therapy. Affected lots shipped to the USA between 2023-2026.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astellas is recalling Prograf (tacrolimus) capsules because some shipments may contain empty capsules. This could lead to medication failure for people taking immunosuppressant therapy.
The capsules may be empty, meaning they contain no medication. This could cause medication failure for people taking immunosuppressant therapy, as the drug is needed to prevent organ rejection after transplants.
People prescribed Prograf for immunosuppressant therapy who have the specific lot numbers listed in the recall. Those with the NDC 0469-0607-73 and lot number 0E3353D are most at risk.
Check for the NDC code 0469-0607-73 and lot number 0E3353D on the bottle. The product was shipped to the USA between 2023 and 2026.
Open the bottle and check if capsules are empty. If empty, do not use the bottle.
The recall is due to potential empty capsules in some shipments, which could cause medication failure for immunosuppressant therapy.
Check for NDC code 0469-0607-73 and lot number 0E3353D on the bottle. The product was shipped to the USA between 2023 and 2026.
Open the bottle and check if capsules are empty. If empty, do not use the bottle.
We’ve drafted a message you can send Astellas to request your refund or repair — edit it as you like.
Subject: Recall D-0211-2025 — Astellas Astellas Hello, I own a Astellas that is covered by recall D-0211-2025 from Astellas. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
