Fentanyl System Patch
FDA Recall NDC 47781-428
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Fentanyl System (NDC 47781-428). A significant event, classified as Class I, was initiated on Jan 31, 2025 by Alvogen. The reported reason for this action was: "Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
January 2025 Class I Recall: Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Recall Number
Class I Ongoing
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Jan 31, 2025
Feb 26, 2025
112,128 cartons (5 pouches/carton)
Recall Profile & Regulatory Data
Event ID
96222
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Alvogen, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
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
47781-423-11Product
47781-423-47Product
47781-424-11Product
47781-424-47Product
47781-426-11Product
47781-426-47Product
47781-427-11Product
47781-427-47Product
47781-428-11Product
47781-428-47Product
Class I Terminated
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Apr 19, 2019
May 15, 2019
119,608 cartons
Recall Profile & Regulatory Data
Event ID
82669
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Alvogen, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Aug 14, 2019
Product Description
FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47.
Batch or Lot Expiration Information
Lot# : 180060, Exp 05/2020; 180073, Exp 06/2020.
Affected Packages Involved in this Recall
47781-423-11Product
47781-423-47Product
47781-424-11Product
47781-424-47Product
47781-426-11Product
47781-426-47Product
47781-427-11Product
47781-427-47Product
47781-428-11Product
47781-428-47Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
