Elevated risk U.S. Food and Drug Administration

Astellas Tacrolimus and Tacrolimus Extended-Release capsules recall: Bottles may contain empty capsules

Recall published 1+ years ago

Bottles may contain empty capsules.

Astellas Prescription & OTC drugs — recalled prescription & otc drugsAstellas Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Drug safety concern

A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

What the notice says: Transplant patients who consume empty PROGRAF or ASTAGRAF XL capsules may experience initiation of rejection of the transplanted organ, tissue, or cells, due to underimmunosuppression.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
December 23, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Astellas
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Tacrolimus and Tacrolimus Extended-Release capsules

What the company announced

FOR IMMEDIATE RELEASE – NORTHBROOK, IL, Dec. 23, 2024 – Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, "Astellas") is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules to the consumer level. These products are being recalled because bottles may contain empty capsules.

Risk Statement

Transplant patients who consume empty PROGRAF or ASTAGRAF XL capsules may experience initiation of rejection of the transplanted organ, tissue, or cells, due to underimmunosuppression. In the case of life sustaining organ transplants such as a heart transplant (for which there is no permanent substitute such as hemodialysis in the case of a failed kidney transplant) if the transplant fails, the consequences of rejection initiated by ingesting empty capsules may be fatal. To date, Astellas has not received any reports of adverse events related to this recall.

PROGRAF and ASTAGRAF XL are immunosuppressive medicines, used in conjunction with other medicines, to help prevent organ transplant rejection. PROGRAF is used in people who have had kidney, heart, liver, or lung transplants and ASTAGRAF XL is indicated for use in people with kidney transplants.

The affected lot numbers and expiration dates are:

  • PRODUCT DESCRIPTION: PROGRAF® (tacrolimus) 0.5 mg capsules 100 capsules per bottle · NDC: 0469-0607-73 · LOT NO.: 0E3353D · EXP. DATE: 03/2026
  • PRODUCT DESCRIPTION: ASTAGRAF XL® (tacrolimus extended- release capsules) 0.5 mg capsules 30 capsules per bottle · NDC: 0469-0647-73 · LOT NO.: 0R3092A · EXP. DATE: 03/2026

No other formulations or doses of the product are impacted, and sufficient supply of unaffected stock is available to replace the recalled lots. Product was distributed nationwide to wholesale and retail outlets.

Astellas is notifying its customers via a drug recall notification letter and is arranging for the return of impacted product. Wholesalers or pharmacists with questions about the recall process should contact 1-877-575-3437 during office hours 9 am to 5 pm (EST), Monday through Friday.

Patients that have an affected lot should contact their physician or healthcare provider. Patients and physicians with questions should contact Astellas Medical Information at 1-800-727-7003 During office hours from 9 am to 5:30 pm EST, Monday through Friday.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About PROGRAF® 0.5mg (tacrolimus)

Please see the accompanying Patient Information and full Prescribing Information , including Boxed Warning.

About ASTAGRAF XL® 0.5mg (tacrolimus)

Please see the Medication Guide and full Prescribing Information , including Boxed Warning .

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com .

Cautionary Notes

In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 0E3353D
  • 0R3092A

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 03/2026

NDC number

On the carton and again on the bottle or blister label.

  • 0469-0607-73
  • 0469-0647-73

Package size

Match the net weight or the piece count on the front of the pack.

  • 0.5 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Astellas — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

  1. Check the lot number on your pack against the codes listed above.
  2. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  3. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  4. Keep the carton; the lot number is often printed only on the outer pack.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.

Company contact: Astellas Pharma US, Inc. — Consumers: Astellas Medical Information, 1-800-727-7003 — Media: US Commercial Communications, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Astellas prescription & otc drugs recalled?

Bottles may contain empty capsules. Transplant patients who consume empty PROGRAF or ASTAGRAF XL capsules may experience initiation of rejection of the transplanted organ, tissue, or cells, due to underimmunosuppression.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 0E3353D, 0R3092A; best-by date 03/2026. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The notice says: Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of…

Where was the recalled product sold?

It was distributed nationwide.

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