Fentanyl Transdermal System (Alvogen) – Product Mix-Up (2019)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47.
Brand
Alvogen, Inc
Lot Codes / Batch Numbers
Lot#: 180060, Exp 05/2020, 180073, Exp 06/2020.
Products Sold
Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.
Alvogen, Inc is recalling FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: due to Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 5. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026