Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway
Summary
The FDA issued a Class III for Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by NOVADOZ PHARMACEUTICALS LLC. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0300-2026
Action Date
2026-02-04
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027
Quantity Affected: N/A
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-15
Company
Piscataway, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 35 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NOVADOZ PHARMACEUTICALS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NOVADOZ PHARMACEUTICALS LLC have FDA actions?
This is the only FDA action we have on record for NOVADOZ PHARMACEUTICALS LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0300-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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