January 2025 FDA Recall Fentanyl System by Alvogen, Inc
D-0245-2025 - Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

This Class I drug recall was voluntarily initiated by Alvogen, Inc on January 31, 2025 for the product Fentanyl System. The FDA reported the reason for recall as defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0245-2025

Reason for Recall
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Initiated
01-31-2025
Reported
02-26-2025
Quantity
112,128 cartons (5 pouches/carton)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96222
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Alvogen, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# : 108319, Exp: 04/30/2027

Affected Packages Involved in this Recall

47781-423-11 Fentanyl System
47781-423-47 Fentanyl System
47781-424-11 Fentanyl System
47781-424-47 Fentanyl System
47781-426-11 Fentanyl System
47781-426-47 Fentanyl System
47781-427-11 Fentanyl System
47781-427-47 Fentanyl System
47781-428-11 Fentanyl System
47781-428-47 Fentanyl System