The Food and Drug Administration (FDA) has announced a recall of specific lots of sildenafil (AvKARE LLC) and trazodone (AvKARE LLC) tablets due to a product mix-up.

AvKARE is voluntarily recalling 1 lot of sildenafil 100 mg tablets and 1 lot of trazodone 100mg tablets due to a product mix-up. The 2 separate products were inadvertently packaged together during bottling at a 3rd party facility.

Sildenafil, the active ingredient in Viagra, is used for the treatment of erectile dysfunction; unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues. Trazodone is indicated for the treatment of major depressive disorder; unintended intake of trazodone may result in adverse health consequences such as somnolence/sedation, dizziness, constipation, and blurred vision.

To date, AvKARE has not received any reports of adverse events related to this recall.

Food and Drug Administration (FDA). AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up [news release]. December 9, 2020. Available at: click here. Accessed December 10, 2020.