Alvogen, Inc recalls Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed

Recalled February 26, 2025 · FDA recall D-0245-2025 · Alvogen

Hazard

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch. · FDA Class I

Units

112,128 cartons (5 pouches/carton)

Sold at

USA Nationwide

Description

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

Product

Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.

Manufacturer(s)

Alvogen, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →