Recall Record

Rosenberg, TX, United States

Seatex LLC recalls

2 recalls recorded since 2018, most recently on 19 February 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0

Terminated Class II Drugs

Recall started
19 February 2024
Terminated
15 August 2025
Reason
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Distribution
Nationwide in the US and Puerto Rico
Initiated
Voluntary: Firm initiated
Recall numbers
D-0357-2024, D-0360-2024, D-0359-2024, D-0356-2024, D-0358-2024

Ongoing Class II Drugs

Recall started
19 April 2023
Reason
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Distribution
FL, GA, TX
Initiated
Voluntary: Firm initiated
Recall number
D-0562-2023

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.