Alvogen, Inc: Drug Recall

Recall #D-0245-2025 · 01/31/2025

Class I: Dangerous

Recall Details

Recall Number: D-0245-2025
Classification: Class I
Product Type: Drug
Recalling Firm: Alvogen, Inc
Status: Ongoing
Date Initiated: 01/31/2025
Location: Morristown, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product 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.

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.

Distribution Pattern

USA Nationwide

Other Recalls by Alvogen, Inc

Class II: Risk 12/31/2025

Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Class II: Risk 02/06/2023

Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class II: Risk 02/26/2021

Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)

View all recalls by Alvogen, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.