Fentanyl Patch (Alvogen) – Defective Delivery System (2025)
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 CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.
Brand
Alvogen, Inc
Lot Codes / Batch Numbers
Lot #: 108319, Exp: 04/30/2027
Products Sold
Lot #: 108319, Exp: 04/30/2027
Alvogen, Inc is recalling Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, R due to Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.. 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
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
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