Fentanyl Transdermal Patches Recalled for Defective Delivery System
Alvogen has recalled Fentanyl Transdermal System patches (25 mcg/h) nationwide due to a manufacturing defect where patches may be stacked together in a single pouch. Patients using affected lots should contact their healthcare provider.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall. The defective delivery system—where multiple patches can be stacked in a single pouch—creates a risk of improper fentanyl dosing, and fentanyl is a potent opioid where incorrect dosing has serious health consequences.
Plain-English summary
Alvogen, Inc. has recalled Fentanyl Transdermal System patches (25 mcg/h) distributed nationwide. The recall affects 112,128 cartons (5 pouches per carton) of Lot #108319, with an expiration date of 04/30/2027.
The patches have a defective delivery system where multiple patches may adhere to one another and be stacked on top of each other within a single product pouch. When patients apply what they believe to be a single patch, they may actually be applying multiple patches, resulting in improper fentanyl dosing.
Patients who may be using affected patches from Lot #108319 should contact their healthcare provider or pharmacy to verify whether they are affected and discuss appropriate next steps. Healthcare providers should check patient records for this lot number and assess whether affected patients need medical evaluation or medication replacement. The product is manufactured by Kindeva Drug Delivery L/P and distributed by Alvogen, Inc.
The recalled product
- Product
- FENTANYL SYSTEM (FENTANYL)
- Brand
- FENTANYL SYSTEM
- Manufacturer
- Alvogen, Inc
- Hazard
- delivery-system-defect
- improper-dosing
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 108319
- Exp: 04/30/2027
Distribution
Distributed nationwide across the United States.
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