In February 2004, a leading fentanyl supplier, Janssen Pharmaceutica Products, L.P. recalled one lot of fentanyl (brand name: Duragesic) patches because of seal breaches which may allow the drug to leak from the patch. The recall notice warned that "exposure to the Duragesic hydrogel contents could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications." Janssen also later recalled additional lots; a series of Class II Recalls were then initiated in March 2004 due to a potentially life-threatening manufacturing defect. At least one fatality, possibly due to the defect, has been reported to the American FDA.

The 25 mcg/hr Duragesic patches manufactured by ALZA Corporation were also recalled in February 2008 due to a concern that small cuts in the gel reservoir could result in accidental exposure of patients or health care providers to the fentanyl gel. Overexposure in patients, or even slight exposure in non opioid tolerant people, could possibly result in a fatal overdose.