LIDOcaine 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 LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal &…

Recall number

D-0503-2025

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

LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.