Glycopyrrolate Liquid
FDA Recall NDC 72205-070
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Glycopyrrolate (NDC 72205-070). A significant event, classified as Class III, was initiated on Dec 15, 2025 by Novadoz Pharmaceuticals Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
December 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications
Dec 15, 2025
Feb 04, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98156
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
NOVADOZ PHARMACEUTICALS LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
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
Batch or Lot Expiration Information
Lot# CB2505159A, CB2505160A, Exp Date: 04/2027
Lot# CB2505161A, Exp Date: 05/2027
Affected Packages Involved in this Recall
72205-070-72Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
