US-based pharmaceuticals company Alvogen, Inc. announced on Friday that it is recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level.

The recalled lot is Lot 108319 25 mcg/h with expiration date April 2027.

Alvogen is recalling the product as the patches could potentially be multi-stacked, adhered one on top of the other, in a single product pouch. 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. The firm has received one serious adverse event related to this recall to date.

Kindeva Drug Delivery LP, Northridge, California manufactures the transdermal system, which is distributed by Alvogen, Inc. as a private label distributor.