The liquid dietary supplement, taken for erectile dysfunction, contains Tadalafil, making the product an unapproved drug for which safety and efficacy have not been established.
The company says it has not received any reports of adverse events related to this recall.
The recalled product is packaged in an 8.5- fl. oz., bottle. The following lots are being recalled:
- LOT: ZD-160-18 EXP: 09-07-2019,
- LOT: ZD-078-19 EXP: 27-04-2020,
- LOT: ZD-159-17 EXP: 31-05-2018.
It was distributed nationwide to retail stores and through the internet beginning in April, 2019.
What to do
Fitoterapia USA is notifying its customers by mail and email and arranging for return of all recalled products.
Consumers with questions may contact the firm by email at info@fitoterapiausa.com.