Drug FDA Class I Ongoing Quality
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.
Alvogen, Inc Published Feb 26, 2025
Risk level
Class IDangerous or defective — could cause serious health problems or death.
Severity score 85/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Alvogen, Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Affected products (1)
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.
FENTANYL SYSTEM · 112,128 cartons (5 pouches/carton)
NDC: 47781-423, 47781-424, 47781-426, 47781-427, 47781-428, 47781-423-11, 47781-423-47, 47781-424-11, 47781-424-47, 47781-426-11, 47781-426-47, 47781-427-11, 47781-427-47, 47781-428-11, 47781-428-47
Code info: Lot #: 108319, Exp: 04/30/2027
Affected areas
Nationwide
Timeline
- InitiatedJan 31, 2025
- PublishedFeb 26, 2025
- Recall number
- D-0245-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.