Glycopyrrolate Injection, Solution
FDA Recall NDC 63323-578
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 63323-578). A significant event, classified as Class II, was initiated on Jul 16, 2026 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Presence of Particulate Matter: Hair was found in product"
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
Class II Ongoing
Presence of Particulate Matter: Hair was found in product
Jul 16, 2026
Jul 29, 2026
59,425 vials
Recall Profile & Regulatory Data
Event ID
99449
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within in the USA
Product Description
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
Batch or Lot Expiration Information
Lot# : 6134349, 6134620 Exp. Date 11/2026
Affected Packages Involved in this Recall
63323-578-03Product
63323-578-01Product
63323-578-04Product
63323-578-02Product
63323-578-07Product
63323-578-05Product
63323-578-18Product
63323-578-20Product
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.
