Recall Record

Brooklyn, NY, United States

Junp Hydration LLC recalls

1 recall recorded since 2018, most recently on 4 February 2022. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1

Terminated Class I Drugs

Recall started
4 February 2022
Terminated
9 June 2022
Reason
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Distribution
Product was distributed nationwide in the USA via Amazon Marketplace
Initiated
Voluntary: Firm initiated
Recall number
D-0557-2022

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.