Fresenius Kabi Usa, Llc: Glycopyrrolate Injection, Usp, 1 Mg Per
Recall Summary Fresenius Kabi is recalling Glycopyrrolate Injection (a medication used during anesthesia and surgery) because hair was found in some vials. The recall affects multiple-dose vials distributed nationwide across all U.S. states and Washington, D.C. This is classified as a Class II recall, meaning use of the product could cause adverse health effects.
- Recalling firm
- 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-07-16
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/8820eca5-608b-46f9-a25e-b7072392d004