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.

Ketamine HCl 50mg per 5mL (10 mg per mL) Recalled by Denver Solutions, LLC DBA Leiters Health Due to Lack of Assurance of Sterility: Leaking/damaged syringes.

Date: March 31, 2025
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

Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11

Quantity: 49,830 syringes

Why Was This Recalled?

Lack of Assurance of Sterility: Leaking/damaged syringes.

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