Recall Record

Portland, OR, United States

Today The World recalls

1 recall recorded since 2018, most recently on 6 February 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1

Ongoing Class I Drugs

Recall started
6 February 2024
Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Distribution
Product distributed nationwide within the United States.
Initiated
Voluntary: Firm initiated
Recall numbers
D-0345-2024, D-0344-2024, D-0343-2024

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.