Recall Record

Zug, Switzerland

BE PHARMACEUTICALS AG recalls

2 recalls recorded since 2018, most recently on 10 January 2024. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0

Terminated Class II Drugs

Recall started
10 January 2024
Terminated
10 June 2025
Reason
Lack of Sterility Assurance: Aseptic process simulation failure.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0262-2024

Terminated Class II Drugs

Recall started
5 September 2023
Terminated
8 April 2025
Reason
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-1148-2023

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.