Recalls / Class I
Class ID-0245-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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 name
- Fentanyl System
- Generic name
- Fentanyl
- Active ingredient
- Fentanyl
- Route
- Transdermal
- NDCs
- 47781-423, 47781-424, 47781-426, 47781-427, 47781-428
- FDA application
- ANDA202097
- Affected lot / code info
- Lot #: 108319, Exp: 04/30/2027
Why it was recalled
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Recalling firm
- Firm
- Alvogen, Inc
- Manufacturer
- ALVOGEN
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 44 Whippany Rd Ste 300, N/A, Morristown, New Jersey 07960-4558
Distribution
- Quantity
- 112,128 cartons (5 pouches/carton)
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-01-31
- FDA classified
- 2025-02-20
- Posted by FDA
- 2025-02-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0245-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.