FDA Class I Recall: Astagraf XL Immunosuppressant Capsules May Be Empty
Astellas Pharma is recalling Astagraf XL (tacrolimus) due to manufacturing defects; bottles shipped nationwide may contain empty capsules instead of medication.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA's Class I classification mandates a minimum severity score of 4. Empty capsules prevent patients from receiving their prescribed medication dose, creating a significant risk of therapeutic failure.
Plain-English summary
Astellas Pharma US Inc. is recalling Astagraf XL (tacrolimus extended-release capsules, 0.5 mg) due to failed capsule specifications. Bottles shipped to the United States may contain empty capsules instead of the medication.
The affected product is lot number 0R3092A with expiration date 03/31/2026. The recall involves 3,500 30-count bottles distributed nationwide. The FDA has classified this as a Class I recall.
Patients and caregivers with this product should contact their healthcare provider or pharmacy immediately to verify their medication supply and discuss any concerns.
The recalled product
- Product
- ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES)
- Brand
- ASTAGRAF XL
- Manufacturer
- Astellas Pharma US Inc.
- Category
- Drug — Immunosuppressant
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 0R3092A
- EXP 03/31/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Astellas Pharma US Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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