Reported Feb 26, 2025 · Ongoing

Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed…

Alvogen, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alvogen, Inc · 44 Whippany Rd Ste 300 · Morristown, NJ · 07960-4558

Is this the product you have?

  • Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only
  • Distributed byAlvogen, Inc., Pine Brook, NJ 07058
  • Manufactured byKindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47
Lot codes and dates
  • Lot #: 108319
  • Exp04/30/2027
Amount recalled
112,128 cartons (5 pouches/carton)

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:06 PM UTC

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