Recall Record

Sacramento, CA, United States

Boulla LLC recalls

1 recall recorded since 2018, most recently on 4 November 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
4 November 2024
Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Distribution
Nationwide within the United States
Initiated
Voluntary: Firm initiated
Recall numbers
D-0086-2025, D-0083-2025, D-0084-2025, D-0085-2025

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.