Glycopyrrolate recall — Class II (D-0370-2025) · pharmaranks
Class IIOngoing
Glycopyrrolate recall
FDA recall D-0370-2025 · initiated Mar 31, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Leaking/damaged syringes.
Details
Product
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
Recalling company
Denver Solutions, LLC DBA Leiters Health
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide in the U.S.A
Initiated
Mar 31, 2025
FDA report date
Apr 30, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.