Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Fentanyl Transdermal System CII Recalled by Alvogen, Inc Due to Defective delivery system - patches could be multi-stacked,...

Date: January 31, 2025
Company: Alvogen, Inc
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alvogen, Inc directly.

Affected Products

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.

Quantity: 112,128 cartons (5 pouches/carton)

Why Was This Recalled?

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Alvogen, Inc

Alvogen, Inc has 21 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report