Class II · Moderate risk
Glycopyrrolate Injection
Presence of Particulate Matter: Hair was found in product
Is Glycopyrrolate recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Glycopyrrolate (49 total). Check the affected lots below.
Most common reason: Sterility / contamination (21 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Glycopyrrolate. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Glycopyrrolate recalls in 2026
2 initiated in 2026, 49 in total — newest first
Class II · Moderate risk
Glycopyrrolate Oral Solution
Failed Impurities/Degradation Specifications
Class III · Low risk
Glycopyrrolate Oral Solution
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Glycopyrrolate
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
glycopyrrolate 1 mg/5 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class III · Low risk
Glycopyrrolate Injection
Labeling: Label Mix-up
Class III · Low risk
Glycopyrrolate Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Glycopyrrolate Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glycopyrrolate Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glycopyrrolate Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glycopyrrolate Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glycopyrrolate Tablets
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Class II · Moderate risk
Glycopyrrolate Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Glycopyrrolate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate Tablets
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Class III · Low risk
Glycopyrrolate Injection
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Bevespi Aerosphere
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Glycopyrrolate Injection
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Class II · Moderate risk
Glycopyrrolate 1 mg/5mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Glycopyrrolate Tablets
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Class III · Low risk
Glycopyrrolate Injection
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Class II · Moderate risk
Glycopyrrolate Tabs
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
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