Fresenius Kabi USA, LLC recalls Glycopyrrolate Injection
- Recalling company
- Fresenius Kabi USA, LLC
- 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
- Reason
- Presence of Particulate Matter: Hair was found in product
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 16, 2026
- Reported
- Jul 29, 2026
- Distribution
- Nationwide within in the USA
- Status
- Ongoing
- Quantity
- 59,425 vials
- Lot / codes
- Lot #: 6134349, 6134620 Exp. Date 11/2026
- Company location
- Lake Zurich, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0725-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0725-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.