Fentanyl Patches Recalled Nationwide as Warning Issued

A batch of fentanyl transdermal patches have been recalled nationwide by Alvogen Inc. on Friday as the company warned on Friday that there is potential that they could be multi-stacked leading to life-threatening concerns.

Newsweek has reached out to Alvogen Inc. via online email form for comment on Saturday morning.

Why It Matters

While fentanyl is a strong opioid to treat pain, when used for a long time, it may become habit-forming, causing mental or physical dependence. This comes as the opioid crisis is one of the most urgent public health challenges in the United States.

However, according to the U.S. Food and Drug Administration (FDA), the fentanyl transdermal system is a patch prescribed by health care professionals to be applied to the skin as the patch treats and manages opioid-tolerant patients who need daily, round-the-clock, long-term pain medicine.

What To Know

According to the recall announcement on the FDA’s website, Alvogen, Inc. said it’s voluntarily recalling nationwide one lot of fentanyl patches due to the possibility that the patches could be multi-stacked in a single product pouch.

It’s being warned that the application of a multi-stacked patch could result in serious, life-threatening, or fatal respiratory depression, noting that groups at potential increased risk could include first-time recipients of such patches, children, and the elderly.

The recall affected one lot of Fentanyl Transdermal System, 25 mcg/h, distributed nationwide to the pharmacy and patient level and has a lot number of 108319 with an expiration date 04/2027.

This transdermal system is manufactured by Kindeva Drug Delivery L.P. from Northridge, California, and is distributed by Alvogen, Inc. as a private label distributor.

According to the recall announcement, Alvogen, Inc. is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products.

In addition, pharmacies are requested not to dispense any product subject to the recall.

So far, Alvogen has received one serious adverse event related to this recall.

What People Are Saying

U.S. Food and Drug Administration (FDA) previously said on its website about how to dispose fentanyl patches to prevent accident exposure: “The FDA recommends promptly disposing of used patches by folding them in half with the sticky sides together, and then flushing them down a toilet. Patches should not be placed in the household trash, where children or pets can find them.”

Speaking on the opioid crisis and the impact of harm reduction, Daliah Heller, vice president, Vital Strategies, Public Health Policy, previously told Newsweek: “Harm reduction efforts are succeeding. Over the past year, we began witnessing precipitous declines in overdose for the first time since fentanyl-driven deaths skyrocketed in 2020: deaths are now down nationally by 14% according to the most recent data from CDC.”

She added: “This decline has been attributed in part to harm reduction efforts, including the expanded availability of naloxone for overdose reversal, improved low barrier access to medication treatment in the community, and the adoption of protective practices such as drug checking among people who are using drugs.”

What Happens Next

According to the recall announcement, patients that have the affected lot should immediately remove any patch currently in use and contact their health care provider. Any patients with unused product should return it to point of purchase for replacement.

Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using the product.