Recall Record

Phoenix, AZ, United States

Tailstorm Health INC recalls

3 recalls recorded since 2018, most recently on 2 June 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0

Ongoing Class II Drugs

Recall started
2 June 2025
Reason
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Distribution
Nationwide in the US
Initiated
Voluntary: Firm initiated
Recall numbers
D-0500-2025, D-0502-2025, D-0501-2025, D-0499-2025, D-0498-2025, D-0503-2025

Terminated Class II Drugs

Recall started
6 November 2024
Terminated
28 March 2025
Reason
Lack of Sterility Assurance
Distribution
Nationwide Within U.S.
Initiated
Voluntary: Firm initiated
Recall number
D-0051-2025

Ongoing Class II Drugs

Recall started
3 July 2024
Reason
Subpotent Drug: reduced efficacy for epinephrine
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0594-2024

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.