Fentanyl Patches Recalled Due to Multi-Stacked Patches

February 3rd, 2025 (Chicago, IL) – Alvogen Inc. has voluntarily recalled one lot of Fentanyl transdermal patches because they may be stacked and adhered to one another inside single pouches. The affected products were manufactured by Kindeva Drug Delivery L.P. in Northridge, CA, and distributed by Alvogen Inc. as a private label distributor. 

Woman using patches to tend her wounds.

Applying these multi-stacked Fentanyl patches can result in life-threatening or fatal respiratory depression. This is a condition where one’s breathing is slowed and/or shallow, leading to inadequate gas exchange in the lungs. This can result in hypoxemia (low levels of oxygen in the blood) and hypercapnia (high levels of carbon dioxide in the blood) and can result in cardiac arrest or respiratory failure. To date, only one serious adverse reaction has been reported relating to the Fentanyl transdermal patch recall.

Alvogen is contacting distributors and direct customers via certified letter and is arranging for returns and replacements on all recalled products, The distributor has requested that pharmacies not dispense any of the products subject to the recall.

What Lot of Fentanyl Patches Are Included in the Recall?

There is currently one lot of Alvogen Fentanyl patches that has been recalled due to the possibility of the patches being multi-stacked. The cartons of patches are indicated for severe and persistent pain in opioid-tolerant patients, for which alternative treatment options are inadequate. The product is primarily packaged in cartons of 5 individually wrapped pouches. These cartons have a lot code of 108319, and are labeled as Fentanyl Transdermal System, 25mcg/h, with an expiration date of 04/2027. This lot was distributed nationwide to pharmacies and patients.

What Is Fentanyl?

Fentanyl is a synthetic opioid used for pain management in patients with severe chronic pain or pain following surgery. Patients taking this medication should be monitored for possible abuse and misuse. However, when used as directed, and under proper medical supervision, this drug can provide pain relief to those in need. 

Fentanyl is also available through illicit channels. However, obtaining the drug illegally is highly dangerous due to the lack of regulation and quality control. Counterfeit pills may contain lethal doses, increasing the risk of accidental overdose and death. Fentanyl is approximately 100 times more potent than morphine. Just 2mg of fentanyl can be a lethal dose, depending on a person’s body weight. 

Obtaining Fentanyl through legitimate means, such as through a prescription from your doctor, ensures the medication is safe, and the dosage is correct. 

According to the CDC, synthetic opioids, like Fentanyl, are a primary source of overdose in the United States. From January 2020 to January 2021, opioid-related overdoses rose by 38.1%, and overdoses involving synthetic opioids rose 55.6%.

What Are the Symptoms of Fentanyl Overdose?

Symptoms of Fentanyl overdose can include:

  • Slow or no breathing
  • Drowsiness
  • Disorientation
  • Sedation
  • Pinpoint Pupils
  • Skin rash
  • Clammy skin

Seek immediate medical attention if you suspect someone has accidentally been exposed to too much fentanyl. If contact was through the person’s mouth or eyes, and the victim is still conscious, rinse the affected area with cold water immediately. If fentanyl comes into contact with the skin, the individual should avoid touching their face and wash the affected area with soap and water immediately. Do not use hand sanitizer or bleach products to clean skin, as this could increase the absorption of the Fentanyl. 

As soon as the affected area has been rinsed, contact emergency medical services right away. If you have Narcan (naloxone) available, make sure to give it to the affected person if they are exhibiting overdose symptoms. Naloxone/Narcan is a life-saving drug that can reverse the effects of opioids, including fentanyl, during an overdose.

What Should I Do With Unused Recalled Fentanyl Patches?

If you are wearing a patch affected by this recall, you should remove it and contact your health care provider right away. Return any unused product to the point of purchase for a refund or replacement. 

Do not dispose of used or unused Fentanyl patches in the trash. Even after three days of use, these patches may still contain up to 50% of the labeled amount. This could be enough to cause serious harm or death to unsuspecting children, pets, sanitation workers, and others. 

To safely dispose of Fentanyl transdermal patches, remove the patch while wearing nonabsorbent, protective gloves. Fold so that the adhesive sides of the patch are stuck together. Place the patch in a sharps container or another sealed, childproof container, and take the container to a nearby medicine take-back program or speak with your healthcare provider or pharmacist for advice. Be sure to wash your hands thoroughly after handling the pain patches. 

If you are experiencing any adverse reactions after using the recalled fentanyl patches or becoming accidentally exposed to the medication, contact your doctor or local emergency room right away.  You can report adverse events related to the patched to the FDA’s MedWatch Adverse Event Reporting program online, or by mail or fax.

Fentanyl overdose can be fatal. If you suffered injuries or your loved one died after using the recalled patched, you may have legal options. The experienced product liability lawyers at Ankin Law in Chicago are here to help. 

We have over 100 years of combined experience handling cases involving unreasonably dangerous products. Contact us right away for legal assistance. There are no upfront attorney fees, and free consultations are available to help you get started with your claim. 

Chicago personal injury and workers’ compensation attorney Howard Ankin has a passion for justice and a relentless commitment to defending injured victims throughout the Chicagoland area. With decades of experience achieving justice on behalf of the people of Chicago, Howard has earned a reputation as a proven leader in and out of the courtroom. Respected by peers and clients alike, Howard’s multifaceted approach to the law and empathetic nature have secured him a spot as an influential figure in the Illinois legal system.

Years of Experience: More than 30 years
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