BUPIVAcaine HCL Sterile injection recalled over sterility concerns

Recall date

June 2, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Tailstorm Health INC recalls BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose V…

Recall number

D-0499-2025

FDA classification

Class II

Brand / firm

Tailstorm Health INC

Sold / distributed

Nationwide in the US

Why it was recalled

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.