CLASS I ONGOING Drug recall · Reported 5 Feb 2025 · FDA Enforcement Report
Prograf (tacrolimus) capsules, USP, 5 mg recalled by Astellas Pharma US
Astellas Pharma US is recalling Prograf (tacrolimus) capsules, USP, 5 mg, distributed nationwide in the US. The recall was initiated on 23 Dec 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0211-2025
- FDA event ID
- 96008
- Recalling firm
- Astellas Pharma US, Northbrook, IL
- Brand
- Prograf
- Manufacturer
- Astellas Pharma US, Inc.
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 23 Dec 2024
- FDA classified
- 29 Jan 2025
- Reported
- 5 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Packaging Defects
Timeline
| 23 Dec 2024 | Recall initiated by company | |
| 29 Jan 2025 | Classified by FDA | +37 days |
| 5 Feb 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Prograf (tacrolimus) capsules, USP, 5 mg recalled?
Yes. Astellas Pharma US recalled Prograf (tacrolimus) capsules, USP, 5 mg on 23 Dec 2024. The recall is Class I and its status is Ongoing. Recall number D-0211-2025.
Why was it recalled?
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Which lots are affected?
Lot# 0E3353D, Exp 03/31/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Astellas Pharma US
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Astagraf XL (tacrolimus extended-release capsules) 5 mg recalledAstagraf Xl | Astellas Pharma US | Packaging Defects | Nationwide |
| Drug | CLASS II | Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial recalledMycamine | Astellas Pharma US | Other | Nationwide |
| Drug | CLASS II | Tarceva (erlotinib) Tablets, 150 mg recalled by Astellas Pharma US | Astellas Pharma US | Potency & Assay | Nationwide |
| Drug | CLASS II | AmBisome (amphotericin B) liposome for injection, 50mg vial recalled | Astellas Pharma US | Sterility | Nationwide |
Other Tacrolimus recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tacrolimus Capsules, USP 1mg recalled by Dr. Reddy's LaboratoriesTacrolimus | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Tacrolimus Capsules, USP, 5 mg recalled by Dr. Reddy's LaboratoriesTacrolimus | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS III | Tacrolimus Ointment, 1%, For Dermatological Use Only recalledTacrolimus | Glenmark Pharmaceuticals Inc., U | Other | Nationwide |
| Drug | CLASS III | Recalled product recalled by Strides PharmaTacrolimus | Strides Pharma | Other | PA |
| Drug | CLASS III | Tacrolimus Capsules, USP 5mg recalled by Mylan PharmaceuticalsTacrolimus | Mylan Pharmaceuticals | Other | Nationwide |