FDA Recall D-0245-2025

Alvogen, Inc · Morristown, NJ

Class I — life-threatening Ongoing 468 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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.

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

Quantity: 112,128 cartons (5 pouches/carton)

Reason for recall

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

Recall record

Recall number: D-0245-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2025-01-31
Classified by FDA Center: 2025-02-20
FDA published: 2025-02-26
Recalling firm: Alvogen, Inc
Firm location: Morristown, NJ

Drug identification

Brand name(s): FENTANYL SYSTEM
Generic name(s): FENTANYL
Manufacturer(s): ALVOGEN
NDC(s): 47781-423, 47781-424, 47781-426, 47781-427, 47781-428
Route(s): TRANSDERMAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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