FDA Drugs recall ·
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0245-2025
- Date
- (initiated January 31, 2025)
- Company / brand
- Alvogen, Inc
44 Whippany Rd Ste 300, Morristown, NJ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 112,128 cartons (5 pouches/carton)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 108319, Exp: 04/30/2027
Distribution
USA Nationwide
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0245-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.