Medication Monitor



Generic Name (Trade Name—Company)
Notes
April 25, 2019

No generic name

(Aphrodisiac capsules—SD Import)
Dietary supplement containing undeclared sildenafil poses health risk

SD Import is voluntarily recalling all lots of aphrodisiac capsules to the consumer level. An FDA analysis found the product is tainted with sildenafil, an FDA-approved active pharmaceutical ingredient (API) used to treat erectile dysfunction. Presence of the sildenafil renders the capsules an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Consumers with diabetes, hypertension, high cholesterol, or heart disease often take nitrates; consumption of undeclared sildenafil along with nitrates could result in a drop in blood pressure that is life-threatening and could result in serious adverse health consequences. 

Aphrodisiac capsules are marketed as a dietary supplement for men for sexual enhancement and are packaged in a cardboard box with 12 plastic packs in a box (UPC Code 644118128135). The product was distributed nationwide to retail stores and a variety of online websites.

SD Imports is notifying its distributors and customers by e-mail and arranging for return of all recalled products.

The company indicated that, to date, it has not received any reports of adverse events related to this recall.