Class I Recall for Hair Loss Drug

MasterPharm is recalling a single lot of Finasteride Plus 1.25-mg capsules because they contain the antihypertensive medication minoxidil, according to the May 20, 2020, US Food and Drug Administration (FDA) Enforcement Report. The FDA designated the recall Class I, a classification that suggests use of the affected product could cause serious adverse health consequences or death. 

“Consumption of undeclared minoxidil would be expected to result in low blood pressure, rapid heartbeat, and salt and water retention causing swelling. Consequently, patients may be at risk for developing heart failure or other heart damage,” MasterPharm stated in a May 6, 2020, announcement. “Excess fluid between the heart and the sac surrounding the heart has also been reported in association with minoxidil use. MasterPharm LLC has received 33 reports of increased heart rate, retention of water, dizziness, and low blood pressure.” 

The recall affects 30- and 90-count bottles of Finasteride Plus 1.25-mg capsules from lot 02-27-2020:04@11, which has an August 25, 2020, expiration date. The capsules were distributed throughout the United States on a patient-specific prescription basis. MasterPharm is notifying customers by phone, e-mail, and letters. 

MasterPharm initiated the voluntary recall April 14, 2020. The FDA designated the recall Class I on May 19, 2020. 

Finasteride Plus is a compounded prescription medication used to treat hair loss.

—Jolynn Tumolo