Glycopyrrolate Solution
FDA Recall NDC 68094-073
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Glycopyrrolate (NDC 68094-073). A significant event, classified as Not Yet Classified, was initiated on Jul 14, 2026 by Precision Dose, Inc.. The reported reason for this action was: "Due to an out-of-specification result for an unidentified impurity detected during routine stability testing."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
July 2026 Not Yet Classified Recall: Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.
Recall Number
Not Yet Classified Ongoing
Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.
Jul 14, 2026
Jul 29, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99388
Classification
Not Yet Classified
Enforcement Status
Ongoing
Recalling Firm
Precision Dose Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
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).
Batch or Lot Expiration Information
Lot# 506033, Exp Date: 11/30/2026.
Affected Packages Involved in this Recall
68094-073-01Product
68094-073-58Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
