Class IOngoing

Fentanyl Transdermal System CII recall

FDA recall D-0245-2025 · initiated Jan 31, 2025

Most serious — a reasonable probability that use will cause serious harm or death.

Why it was recalled

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

Details

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.
Recalling company: Alvogen Inc
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA Nationwide
Initiated: Jan 31, 2025
FDA report date: Feb 26, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0245-2025 ↗

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