Recall Record

Ferndale, MI, United States

Ferndale Laboratories, Inc. recalls

1 recall recorded since 2018, most recently on 25 November 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
25 November 2025
Reason
Butyrate tube cracks during actuation, rendering product unusable.
Distribution
Worldwide distribution - US Nationwide and the country of UK.
Initiated
Voluntary: Firm initiated
Recall number
Z-1005-2026

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.