Ketamine HCl 50mg per recalled over sterility concerns

Recall date

March 31, 2025

Source

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

Official notice title

Denver Solutions, LLC DBA Leiters Health recalls Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewo…

Recall number

D-0373-2025

FDA classification

Class II

Brand / firm

Denver Solutions, LLC DBA Leiters Health

Sold / distributed

Nationwide in the U.S.A

Why it was recalled

Lack of Assurance of Sterility: Leaking/damaged syringes.

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

What was recalled

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