Glycopyrrolate 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 Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englew…

Recall number

D-0370-2025

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

Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11