Recall Record

Elkins Park, PA, United States

ibspot recalls

1 recall recorded since 2018, most recently on 9 October 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 Drugs

Recall started
9 October 2025
Reason
Marketed Without an Approved NDA/ANDA
Distribution
WY and VA
Initiated
Voluntary: Firm initiated
Recall number
D-0098-2026

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.