Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Lidocaine HCL 1% (10mg/mL) Recalled by Denver Solutions, LLC DBA Leiters Health Due to Presence of Particulate Matter: glass vials from the...

Date: February 20, 2024
Company: Denver Solutions, LLC DBA Leiters Health
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Denver Solutions, LLC DBA Leiters Health directly.

Affected Products

Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42

Quantity: 40,890 vials

Why Was This Recalled?

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Denver Solutions, LLC DBA Leiters Health

Denver Solutions, LLC DBA Leiters Health has 22 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report