Alvogen, Inc. is recalling 112,128 cartons of Fentanyl Transdermal System (fentanyl), a prescription pain medication. The recall was issued because a manufacturing defect may have caused multiple patches to be stacked and adhered to each other inside a single pouch. Consumers could unknowingly apply more than one patch at a time, which can cause a life-threatening overdose.
Applying multiple fentanyl patches simultaneously delivers an excessively high dose of opioid medication. This poses a critical risk of severe respiratory depression, coma, or fatal overdose.
You have 2 options:
Patches could be multi-stacked, adhered one on top of the other, in a single product pouch. Quantity affected: 112,128 cartons (5 pouches/carton).
Front of box, Fentanyl Transdermal Patches
Lot codes, Fentanyl Transdermal Patches
Front of package, Fentanyl Transdermal Patches
Back of package, Fentanyl Transdermal Patches
Image of Fentanyl Transdermal patches stuck together
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.