Why it was recalled
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 108319, Exp: 04/30/2027
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0245-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jan 31, 2025
- FDA report date
- Feb 26, 2025
- Quantity
- 112,128 cartons (5 pouches/carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alvogen, Inc
Original FDA data
Every field from FDA enforcement report D-0245-2025, exactly as published.
Show all FDA fields
- City
- Morristown
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96222
- Address
- 44 Whippany Rd Ste 300
- Code information
- Lot #: 108319, Exp: 04/30/2027
- Postal code
- 07960-4558
- Report date
- Feb 26, 2025
- Product type
- Drugs
- Recall number
- D-0245-2025
- Classification
- Class I
- Recalling firm
- Alvogen, Inc
- Product quantity
- 112,128 cartons (5 pouches/carton)
- Reason for recall
- Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jan 31, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 20, 2025