Glycopyrrolate Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIOngoing
Summary: Fresenius Kabi USA, LLC is recalling 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. Reason: Presence of Particulate Matter: Hair was found in product.
What is being recalled
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
Why
Presence of Particulate Matter: Hair was found in product
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within in the USA
How to tell if yours is affected
Lot #: 6134349, 6134620 Exp. Date 11/2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0725-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 16, 2026 |
| Reported | July 29, 2026 |
| Company | Fresenius Kabi USA, LLC |
| Company location | Lake Zurich, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 59,425 vials |
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