In April 2019, certain fentanyl patches were recalled due to an overdose risk. The recalled pain patches were sold in boxes labeled 12 mcg/h when they actually contained 50 mcg/h.

Fentanyl Pain Patch Recall

In April 2019, Alvogen Inc. recalled 2 lots of Fentanyl Transdermal Patches in boxes labeled 12 mcg/h because some pain patches actually contained 50 mcg/h of fentanyl.

Patients who use the product can suffer an accidental overdose of fentanyl.

What is the Problem?

A small number of 50 mcg/h fentanyl pain patches were sold in cartons labeled as 12 mcg/h. The individual patches were correctly labeled as 50 mcg/h but they were placed in mislabeled cartons.

Fentanyl Patch Overdose

Patients who use a 50 mcg/h patch when they were only prescribed a 12 mcg/h patch can overdose and suffer life-threatening respiratory depression or death. To date, Alvogen Inc. has not received any reports of adverse events related to this recall.

What is the Fentanyl Pain Patch?

Fentanyl patches are also called “opioid pain patches.” Doctors prescribe these patches to patients with severe chronic pain, such as end-stage cancer, to manage severe pain in patients who are tolerant to weaker opioids. Fentanyl is 80-100X stronger than morphine.

What Fentanyl Patches Were Recalled?

3M Drug Delivery Systems, of St. Paul, Minnesota, manufactures the Fentanyl Transdermal System. The product is packaged in cartons of 5 individually wrapped and labeled pouches.

The recalled patches were distributed nationwide to pharmacies. The following lots may contain 50 mcg/h patches:

  • Lot 180060 of Fentanyl Transdermal System, 12 mcg/h, expiration date 05/2020.
  • Lot 180073 of Fentanyl Transdermal System, 12 mcg/h, expiration date 06/2020.

What Should I Do?

Patients who are using a recalled pain patch should immediately take it off and contact their health care provider. Patients with unused patches should return it to point of purchase for replacement.

Questions regarding this recall should be directed to Alvogen Customer Complaints by calling 866-770-3024 or sending an e-mail to from Monday to Friday from 9:00 am to 5:00 pm EST.

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