Astellas recalls 0.5mg Astagraf XL capsules due to potential empty capsules in some shipments. Patients should contact their doctor for guidance on next steps.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astellas is recalling 0.5 mg Astagraf XL (tacrolimus) capsules that may contain empty capsules. This could lead to incorrect dosing if the patient takes the capsule thinking it's filled when it's actually empty.
The capsules may be empty, meaning they contain no medication. If a patient takes an empty capsule, they won't receive the intended dose of tacrolimus, which could affect their treatment.
Patients prescribed Astagraf XL 0.5 mg capsules by a doctor in the U.S. who received the recalled product. Those with the specific lot number or expiration date are most at risk.
Check for the product name 'Astagraf XL', strength 0.5 mg, 30-count bottles, and the lot number 0R3092A with expiration date 03/31/2026. This product was distributed by Astellas Pharma US Inc. in the U.S.
Open the bottle and check if the capsules are empty. If empty, do not take the capsule.
The recall states that some bottles may contain empty capsules, so it's not safe to use without checking.
Check the capsules for emptiness. If empty, do not take them. Contact your doctor for guidance.
Look for the product name 'Astagraf XL', 0.5 mg, 30-count bottles, lot number 0R3092A, and expiration date 03/31/2026.
We’ve drafted a message you can send Astellas to request your refund or repair — edit it as you like.
Subject: Recall D-0210-2025 — Astellas Astellas Hello, I own a Astellas that is covered by recall D-0210-2025 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.
