Glycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
Precision Dose Inc. is recalling Glycopyrrolate Oral Solution (1 mg/5 mL) because the product failed to meet specifications for impurities and degradation.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II, which indicates a remote possibility of adverse health consequences.
Plain-English summary
Precision Dose Inc. is recalling Glycopyrrolate Oral Solution, 1 mg/5 mL, which is distributed nationwide in the United States.
The recall was initiated because the product failed to meet specifications regarding impurities and degradation.
Consumers and healthcare providers should check their inventory for the affected product and contact the manufacturer for further information.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- Precision Dose Inc.
- Category
- Drug — Oral Solution
- Hazard
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 (2)
- Lot # 506033
- Exp Date: 11/30/2026.
Distribution
Distributed nationwide across the United States.
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