Checked
Class IIDrug recallOngoing
Glycopyrrolate Injection recall
Recalled by Fresenius Kabi USA, LLC of Lake Zurich, IL · FDA report 07/29/2026
Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.
- Class
- Class II
- Moderate
- Status
- Ongoing
- Recall started
- 07/16/2026
- Distribution
- Nationwide
Reason for recall
Presence of Particulate Matter: Hair was found in product
Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Recalled product
- Product
- 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
- Lot and code info
- Lot #: 6134349, 6134620 Exp. Date 11/2026
- Quantity
- 59,425 vials
- Brand names
- GLYCOPYRROLATE
- Recall number
- D-0725-2026
- Event ID
- 99449
- Initiated by
- Voluntary: Firm initiated
Where it was distributed
Nationwide within in the USA
- Nationwide
Recall timeline
- 07/16/2026Firm started the recall
- 07/23/2026FDA classified it as Class II
- 07/29/2026Published in the FDA enforcement report
All products in this recall
5 products under event 99449
- D-0725-2026Glycopyrrolate 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... This page
- D-0726-2026Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL...
- D-0727-2026Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi...
- D-0728-2026Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich...
- D-0729-2026Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich...
More recalls from Fresenius Kabi USA
- Class IDrugOngoing09/02/2026Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by...Fresenius Kabi USA, LLC · Presence of particulate matter:An internal investigation at the...
- Class IDrugOngoing08/26/2026Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular...Fresenius Kabi USA, LLC · Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL...
- Class IIIDrugOngoing06/17/2026Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047...Fresenius Kabi USA, LLC · Failed Impurities/Degradations Specifications
- Class IMedical deviceOngoing06/10/2026LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.Fresenius Kabi USA, LLC · Potential software anomaly that can cause the pump to report a...
- Class IIMedical deviceOngoing06/10/2026The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.Fresenius Kabi USA, LLC · Potential for the Cassette Loading Lever to break.
- Class IMedical deviceOngoing06/10/2026Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004Fresenius Kabi USA, LLC · Fresenius Kabi has been made aware via customer complaints that...
Frequently asked questions
- Why was Glycopyrrolate Injection recalled?
- Presence of Particulate Matter: Hair was found in product
- What does Class II mean?
- Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
- Where was the recalled product sold?
- Nationwide within in the USA
- Is this recall still active?
- The FDA lists the recall as ongoing. The recall is still in progress.
Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 07/29/2026 · Do not rely on openFDA to make decisions regarding medical care