Alvogen Fentanyl Transdermal Patches recalled due to Patches could be Multi-Stacked, USA

United States

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 lot of Fentanyl Transdermal System was distributed nationwide to the pharmacy and patient level.

There is a possibility that the application of a multi-stacked 25 mcg/h patch could result in serious, life-threatening, or fatal respiratory depression. Groups at potentially increased risk could include first-time recipients of such patches, children, and the elderly. To date, Alvogen has received one serious adverse event related to this recall.

The affected Fentanyl Transdermal System lot is:
- Lot 108319 of Fentanyl Transdermal System
- Size: 25 mcg/h
- Expiration date 04/2027.

Patients who have products subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused products should return them to the point of purchase for replacement.

If you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Alvogen, Inc.
Brand name: Alvogen
Product recalled: Fentanyl Transdermal System 25 mcg/h transdermal patches
Reason of the recall: There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch
FDA Recall date: January 31, 2025

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alvogen-issues-voluntary-nationwide-recall-one-lot-fentanyl-transdermal-system-25-mcgh-due-defective