Glycopyrrolate oral solution recalled after failing impurity and degradation specifications
Novadoz Pharmaceuticals is recalling three lots of Glycopyrrolate Oral Solution, 1 mg/5 mL, after they failed impurities and degradation specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites failed impurity and degradation specifications with no stated clinical consequence.
Plain-English summary
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz (473 mL), Rx only, manufactured by MSN Pharmaceuticals Inc. of Piscataway, New Jersey and distributed by Novadoz Pharmaceuticals LLC, under NDC 72205-070-72, is being recalled.
The reason given in the enforcement record is failed impurities and degradation specifications.
The record's quantity field reads 'N/A'. The recall covers lots CB2505159A and CB2505160A, expiry 04/2027, and lot CB2505161A, expiry 05/2027. Distribution was nationwide in the US. The FDA has classified the action as Class III, its least serious category.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- NOVADOZ PHARMACEUTICALS LLC
- Category
- Drug — Anticholinergic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot # CB2505159A
- CB2505160A
- Exp Date: 04/2027
- Lot # CB2505161A
- Exp Date: 05/2027
Distribution
Distributed nationwide across the United States.
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