Recall Record

Wichita, KS, United States

Fagron Compounding Services recalls

6 recalls recorded since 2018, most recently on 20 March 2026. 5 are listed as ongoing. Status and classification are as published by the FDA.

Recalls6
Ongoing (FDA)5
Terminated or completed1
Class I (FDA)0

Ongoing Class II Drugs

Recall started
20 March 2026
Reason
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Distribution
Nationwide in the U.S.A.
Initiated
Voluntary: Firm initiated
Recall numbers
D-0441-2026, D-0440-2026, D-0439-2026, D-0438-2026, D-0442-2026

Ongoing Class II Drugs

Recall started
20 November 2025
Reason
Incorrect Product Formulation
Distribution
U.S. Nationwide.
Initiated
Voluntary: Firm initiated
Recall number
D-0221-2026

Ongoing Class II Drugs

Recall started
29 August 2025
Reason
Lack of Assurance of Sterility
Distribution
USA nationwide.
Initiated
Voluntary: Firm initiated
Recall number
D-0646-2025

Completed Class II Drugs

Recall started
31 January 2025
Reason
Lack of Assurance of Sterility
Distribution
Distributed in PA
Initiated
Voluntary: Firm initiated
Recall number
D-0225-2025

Ongoing Class II Drugs

Recall started
15 August 2024
Reason
Lack of Assurance of Sterility
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0636-2024

Ongoing Class III Drugs

Recall started
10 November 2023
Reason
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0125-2024

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.