Recall Record

Palmetto, FL, United States

BYL Solutions Inc. recalls

1 recall recorded since 2018, most recently on 30 November 2017. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0

Terminated Class III Drugs

Recall started
30 November 2017
Terminated
11 May 2020
Reason
Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
Distribution
Nationwide
Initiated
Voluntary: Firm initiated
Recall number
D-0414-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.