Antidepressant Under Class I Recall After Product Mix-Up

A Class I recall has been issued for more than 14,368 bottles of trazodone hydrochloride tablets distributed throughout the United States by AvKare Inc. According to the December 23, 2020, US Food and Drug Administration (FDA) Enforcement Report, the antidepressant was inadvertently packaged together with the erectile dysfunction drug sildenafil at a third-party facility.  

The recall affects 1000-count bottles of trazodone hydrochloride tablets, 100 mg (NDC 42291-834-10) from lot 36783 (Exp. 6/22). 

AvKare voluntarily initiated the recall December 7, 2020. On December 16, 2020, the FDA designated the recall Class I, warning use of the recalled product could cause serious adverse health consequences or death. As of December 9, 2020, AvKare had not received any reports of adverse events related to the product mix-up but warned sildenafil could interact with nitrates found in some prescription drugs, lowering blood pressure to dangerous levels.  

Trazodone hydrochloride is a prescription medication indicated for the treatment of patients with major depressive disorder.

—Jolynn Tumolo