Alvogen, Inc drug recall: Fentanyl Transdermal System CII
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96222
- Recall initiated
- Jan 31, 2025
- Classified by FDA
- Feb 20, 2025
- Posted in Enforcement Report
- Feb 26, 2025
- Recalling firm
- Alvogen, Inc
- Firm location
- Morristown, NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jan 31, 2025. FDA classified it 20 days later, on Feb 20, 2025. Distribution reported by FDA: USA Nationwide Alvogen, Inc has 10 recalls in our records.
Recalled products (1)
D-0245-2025 Class I Ongoing
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.
Codes / lots: Lot #: 108319, Exp: 04/30/2027
Quantity: 112,128 cartons (5 pouches/carton)
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 96222
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.