Recall of One Lot of Fentanyl Transdermal System 25 mcg/h Potentially Used in Veterinary Settings

U.S. Food and Drug Administration sent this bulletin at 02/06/2025 05:36 PM EST

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US Food and Drug Administration

Recall of One Lot of Fentanyl Transdermal System 25 mcg/h Potentially Used in Veterinary Settings

**CVM is sharing these announcements because these products may be used in veterinary settings.**

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.

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 potential 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.

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