Class IIIOngoing

Glycopyrrolate Oral Solution recall

FDA recall D-0300-2026 · initiated Dec 15, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Failed Impurities/Degradation Specifications

Details

Product: Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72
Recalling company: NOVADOZ PHARMACEUTICALS LLC
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: US Nationwide.
Initiated: Dec 15, 2025
FDA report date: Feb 4, 2026

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.

Source: openFDA Drug Enforcement record D-0300-2026 ↗

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