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

Recall date

January 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0245-2025

FDA classification

Class I

Brand / firm

Alvogen, Inc

Sold / distributed

USA Nationwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.