US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Jul 14, 2026 (2 months ago)

Glycopyrrolate Oral Solution

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Impurities/Degradation Specifications

What was recalled

Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).

Recalling firm
Precision Dose Inc.
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0741-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Glycopyrrolate recalls

See all
Class II · Moderate risk Ongoing

Glycopyrrolate Injection

Reason Presence of Particulate Matter: Hair was found in product

Fresenius Kabi USA, LLC D-0725-2026
Class III · Low risk Ongoing

Glycopyrrolate Oral Solution

Reason Failed Impurities/Degradation Specifications

Novadoz Pharmaceuticals LLC NDC 72205-070-72 D-0300-2026
Class II · Moderate risk Ongoing

Glycopyrrolate

Reason Lack of Assurance of Sterility: Leaking/damaged syringes.

Denver Solutions, LLC DBA Leiters Health NDC 71449-104-11 D-0370-2025
Class II · Moderate risk Terminated

glycopyrrolate 1 mg/5 mL

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. D-0952-2023
Class III · Low risk Terminated

Glycopyrrolate Injection

Reason Labeling: Label Mix-up

HF Acquisition Co LLC NDC 51662-1487-3 D-0870-2023