Single Lot of Fentanyl Transdermal System 25 mcg/h Recalled by Alvogen Due to Potential for Over-Delivery

MORRISTOWN, NJ: Consumers are advised that on January 31, 2025, Alvogen, Inc., voluntarily recalled a single lot of its Fentanyl Transdermal System 25 mcg/h transdermal patches because a defect was identified in the product’s delivery system.

Fentanyl Transdermal System 25 mcg/h transdermal patches are indicated to help opioid-tolerant patients manage severe and persistent pain. The product is designed to be administered over an extended period and taken with a daily opioid analgesic. Patients typically undergo this course when no other treatment options are adequate.

Manufactured by Kindeva Drug Delivery L.P. in Northridge, California, and distributed by Alvogen, Inc., as a private label, the transdermal system was found to put users at risk for significant, potentially fatal, health risks. Officials say there is a possibility that within a single product pouch, the patches could adhere to the tops of each other. A user who is then inadvertently applied a multi-stacked 25 mcg/h patch may suffer a “serious, life threatening, or fatal respiratory depression.” Children, elderly individuals, and other first-time recipients of multi-stacked patches are especially prone to this risk.

As of this writing, Alvogen, Inc., has received one report of a major adverse event that can be traced to the recalled product.

Packaged in primary cartons containing five pouches individually wrapped and labeled, the affected lot (Lot 108319) of Fentanyl Transdermal System 25 mcg/h has an expiration date of April 2027 (“04/2027”) and was distributed at the pharmacy and patient level across the U.S. Images of the product, including its primary carton, its individual pouches, and how multi-stacked patches might appear, are included in the FDA announcement.

Since the FDA release, certified letters have been sent out to Alvogen, Inc.’s distributing partners and direct customers. A return and replacement program for products under the affected lot has also been established. While receiving pharmacies have been instructed to cease all distribution of the product, patients who have one in their possession are asked to immediately stop using them. Patients are urged to contact their physician if they are experiencing health problems that may be connected to the drug product. Any unused product should also be brought back to the point of purchase for a replacement.

The Alvogen Customer Complaints department is available to field any recall-related questions at the phone number and email listed in the FDA announcement.

The FDA encourages patients and medical providers alike to report to its MedWatch Adverse Event Reporting program about any adverse reactions or quality issues related to the product.

Have you or a loved one suffered an adverse health outcome that can be traced to the use of a defective medical delivery system? After a traumatic and potentially life-threatening experience, your family deserves justice and fair compensation. Our knowledgeable attorneys at Oliver Law Office (Contact Oliver Law Office) provide personalized support and a broad range of experience in mass tort litigation. We are prepared to learn about your case and help you determine the next course of action. Contact us today at 614-220-9100 or online to book a free, no-risk case evaluation.