Recall archive / FDA company announcement

Alvogen: Fentanyl Transdermal System 25 mcg/h transdermal patches — FDA announcement Jan 31, 2025

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jan 31, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Fentanyl Transdermal System 25 mcg/h transdermal patches
Reason: There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch
Classification: Not supplied
Recalling firm: Alvogen, Inc.
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: b33d375675ede32a

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal system is manufactured by Kindeva Drug Delivery L.P., Northridge, CA and is distributed by Alvogen, Inc. as a private label distributor.; The product is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an extended treatment period with a daily opioid analgesic in opioid-tolerant patients, and for which alternative treatment options are inadequate, and is packaged in primary cartons of five individually wrapped and labeled pouches. The affected Fentanyl Transdermal System lot is:; Lot 108319 of Fentanyl Transdermal System, 25 mcg/h, expiration date 04/2027.; This lot of Fentanyl Transdermal System was distributed nationwide to the pharmacy and patient level. See image examples for lot 108319 and a multi-stacked patch.

Label field

Details supplied by the agency

Lot, code or applicability

Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal system is manufactured by Kindeva Drug Delivery L.P., Northridge, CA and is distributed by Alvogen, Inc. as a private label distributor.; The product is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an extended treatment period with a daily opioid analgesic in opioid-tolerant patients, and for which alternative treatment options are inadequate, and is packaged in primary cartons of five individually wrapped and labeled pouches. The affected Fentanyl Transdermal System lot is:; Lot 108319 of Fentanyl Transdermal System, 25 mcg/h, expiration date 04/2027.; This lot of Fentanyl Transdermal System was distributed nationwide to the pharmacy and patient level. See image examples for lot 108319 and a multi-stacked patch.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Jan 31, 2025
Company announcement date: Jan 31, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.