Fentanyl System recalls

Fentanyl System products have been recalled 2 times, most recently on 26 Feb 2025. The recalling company is usually Alvogen. The most common reason is packaging defects.

Total recalls2since 2019
Last 12 months0reported
Class I2100% of total
Ongoing1latest 26 Feb 2025

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 2 100%Class II 0 0%Class III 0 0%

Why fentanyl system is recalled

Companies

Product types

By year

Ongoing fentanyl system recalls

1 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IFentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl SystemAlvogenPackaging DefectsNationwide

All fentanyl system recalls, newest first

2 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IFentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl SystemAlvogenPackaging DefectsNationwide
DrugCLASS IFentanyl Transdermal System, 12 mcg/h, five (12 mcg/h) systems recalledFentanyl SystemAlvogenPackaging DefectsNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.