Alvogen issues nationwide recall of fentanyl patches due to packaging defect

U.S.-based pharmaceutical company Alvogen has issued a voluntary nationwide recall for one lot of its Fentanyl Transdermal System 25 mcg/h patches due to a potential packaging defect.

The recall affects Lot 108319, which has an expiration date of April 2027. According to the company, some product pouches may contain multiple patches stacked together, posing a risk of accidental overdose and life-threatening respiratory depression.

The patches, used for managing severe and persistent pain in opioid-tolerant patients, were manufactured by Kindeva Drug Delivery L.P. in Northridge, California and distributed by Alvogen.

The company has received one report of a serious adverse event related to the issue. Those at higher risk from the defect include first-time users, children, and the elderly. Alvogen has urged pharmacies to stop dispensing the affected lot and is working with distributors and customers to arrange returns and replacements.

Patients currently using a patch from the recalled lot are advised to remove it immediately and consult their healthcare provider. Unused patches should be returned to the point of purchase for a replacement. Consumers experiencing adverse reactions are encouraged to report incidents to the FDA’s MedWatch program.