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Stop using now Drug recall · FDA · Published December 23, 2024

Astellas Recalls Prograf Capsules Due to Empty Capsule Risk

Astellas Pharma recalls specific lots of Prograf (tacrolimus) capsules because bottles may contain empty capsules, posing a serious medication error risk.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0211-2025DrugAstellas ›
Official FDA recall photos · click to enlarge
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Contact the company

Recalling firmAstellas Pharma US Inc.2375 Waterview Dr · Northbrook, IL 60062-6145
✎ GovInfoNow plain-language explainer

Astellas Pharma US Inc. is recalling one lot of Prograf (tacrolimus) capsules, USP, 0.5 mg in 100-count bottles because the product failed specifications by potentially containing empty capsules. This defect affects NDC 0469-0607-73, Lot# 0E3353D with an expiration date of 03/31/2026. Approximately 14,340 bottles were distributed nationwide in the USA. The recall is classified as Class I, indicating a situation where use could cause serious adverse health consequences or death. Read more at govinfonow.com/recall/32344-astellas-recalls-prograf-capsules-due-to-empty-capsule-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32344-astellas-recalls-prograf-capsules-due-to-empty-capsule-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0211-2025

Cite this page

“Astellas Recalls Prograf Capsules Due to Empty Capsule Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32344-astellas-recalls-prograf-capsules-due-to-empty-capsule-risk. Based on FDA recall #D-0211-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0211-2025%22&limit=1).

Astellas Pharma US Inc. recalled Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottles due to potential empty capsules, the FDA said on Dec. 23, 2024.

How to tell if you have it

  • Brand: Astellas
  • Product: Prograf Tacrolimus Capsules
  • NDC: 0469-0607-73
  • Lot#: 0E3353D
  • Expiration: 03/31/2026

The hazard

Bottles shipped to the USA may contain empty capsules, according to the FDA. The recall is classified as Class I.

Context

GovInfoNow's records show Astellas Pharma US Inc. has 3 other recalls on record since 2013-06-19. Other recent recalls of similar products include Aurobindo Pharma recalls 10mg Dicyclomine Capsules due to empty capsules (2026-07-23), Amneal Estradiol Gel Recall: Defective Empty or Partial Packets (2026-09-08), and ANI Pharmaceuticals Recalls Estradiol Gel Due to Defective Containers (2026-05-12).

How to tell if you have this one

Check your bottle for the National Drug Code (NDC) 0469-0607-73 and Lot# 0E3353D. Verify that the expiration date is 03/31/2026. The product is labeled as 'Rx Only' and distributed by Astellas Pharma US, Inc.

  • Brand
    Astellas
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    Nationwide in the USA
Recall numberProduct, codes & lotsQuantityNDC
D-0210-2025Astagraf 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 0469-0647-73.; Lot# 0R3092A, EXP 03/31/20263,500 30-count bottles0469-0647-73, 0469-0647-11, 0469-0677-73, 0469-0677-11, 0469-0687-73, 0469-0687-11
D-0211-2025Prograf (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.; Lot# 0E3353D, Exp 03/31/202614,340 100-count bottles0469-0607-73, 0469-0617-73, 0469-0617-11, 0469-0657-73, 0469-0657-11, 0469-3016-01, 0469-1230-50, 0469-1330-50
Based on the official FDA remedy

What to do — step by step

  1. Stop taking the medication

    Do not consume any capsules from the affected lot until you have consulted your healthcare provider or pharmacist for guidance on replacement.

  2. Contact your pharmacy

    Inform your pharmacist about the recall so they can verify if your current supply is part of Lot# 0E3353D and arrange for a replacement product.

  3. Consult your doctor

    Speak with your prescribing physician immediately to ensure your treatment plan is adjusted safely while you obtain the correct medication.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Dec 23, 202412. FDA classified it Class I: Jan 29, 202523. Published in FDA’s Enforcement Report: Feb 5, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Aurobindo Pharma recalls 10mg Dicyclomine Capsules due to empty capsules
Aurobindo PharmaAmneal Estradiol Gel Recall: Defective Empty or Partial Packets
Amneal PharmaceuticalsANI Pharmaceuticals Recalls Estradiol Gel Due to Defective Containers
ANI PharmaceuticalsApotex Recalls Paroxetine 37.5mg Due to Dissolution Failure
Apotex Corp.Ajanta Pharma Recalls Ranolazine 1000mg Due to Dissolution Failure
Ajanta Pharma USA Inc

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Keep exploring

Where this comes from

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.

  • Official source: FDA Recall #D-0211-2025 (December 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0211-2025 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA