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.
FDA recall notice · announced February 26, 2025 · Alvogen
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The 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.
Reason for recall
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Notes
Distribution: USA Nationwide
Lot/code information: Lot #: 108319, Exp: 04/30/2027
Quantity: 112,128 cartons (5 pouches/carton)
Status: Ongoing
Products in this recall event:
- 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 (D-0245-2025)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.