---
title: "Alvogen: Fentanyl Transdermal System 25 mcg/h transdermal patches — FDA announcement Jan 31, 2025 | Is It on Recall"
description: "There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch"
url: https://isitonrecall.com/recall/fdapress-b33d375675ede32a-alvogen-fentanyl-transdermal-system-25-mcg-h-transdermal-patches/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# Alvogen: Fentanyl Transdermal System 25 mcg/h transdermal patches — FDA announcement Jan 31, 2025

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jan 31, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Fentanyl Transdermal System 25 mcg/h transdermal patches
- **Reason**: There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch
- **Classification**: Not supplied
- **Recalling firm**: Alvogen, Inc.
- **Quantity**: Not supplied
- **Agency-reported status**: Company recall announcement
- **Source record identifier**: b33d375675ede32a

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alvogen-issues-voluntary-nationwide-recall-one-lot-fentanyl-transdermal-system-25-mcgh-due-defective)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal system is manufactured by Kindeva Drug Delivery L.P., Northridge, CA and is distributed by Alvogen, Inc. as a private label distributor.; The product is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an extended treatment period with a daily opioid analgesic in opioid-tolerant patients, and for which alternative treatment options are inadequate, and is packaged in primary cartons of five individually wrapped and labeled pouches. The affected Fentanyl Transdermal System lot is:; Lot 108319 of Fentanyl Transdermal System, 25 mcg/h, expiration date 04/2027.; This lot of Fentanyl Transdermal System was distributed nationwide to the pharmacy and patient level. See image examples for lot 108319 and a multi-stacked patch. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Jan 31, 2025
- **Company announcement date**: Jan 31, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Patients that have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alvogen-issues-voluntary-nationwide-recall-one-lot-fentanyl-transdermal-system-25-mcgh-due-defective)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Alvogen, Inc records](https://isitonrecall.com/brand/alvogen-inc/)