Fentanyl Transdermal System 25 mcg/h transdermal patches

  • There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch
  • Company: Alvogen, Inc.
  • Drugs
  • FDA
  • January 31, 2025

Product details

  • Fentanyl Transdermal System 25 mcg/h transdermal patches

Company announcement

Alvogen, Inc. is recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches nationwide.

The recall is due to the potential for patches to be multi-stacked in a single product pouch.

Application of a multi-stacked patch could result in serious, life-threatening, or fatal respiratory depression.

Alvogen has received one serious adverse event related to this recall.

The affected lot is Lot 108319 with an expiration date of April 2027.

The recall was announced on January 31, 2025.

Risk:

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.

Impacted states: Nationwide

Products:

- Fentanyl Transdermal System 25 mcg/h transdermal patches

Contact

For more information, call 866-770-3024 or email alvogensmb@continuumindia.com.

View the original FDA notice

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