FDA recall D-0300-2026

NOVADOZ PHARMACEUTICALS LLC · Class III · drug

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

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

US Nationwide.

Key facts

Status: Ongoing
Initiation date: 2025-12-15
Report date: 2026-02-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Piscataway, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0300-2026