FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Fresenius Kabi glycopyrrolate injection recalled for hair contamination
Nationwide distribution
Fresenius Kabi glycopyrrolate injection recalled for particulate contamination
Hair was found in some vials of Fresenius Kabi glycopyrrolate injection. The affected product is a prescription medication used during anesthesia and medical procedures. Two lots distributed nationwide are involved.
- Check vials for lot numbers 6134349 or 6134620 (expiration 11/2026)
- Do not use affected vials; quarantine them
- Contact Fresenius Kabi or your pharmacy for replacement product
- Notify your healthcare provider if you received an injection from an affected vial
Hazard
Presence of Particulate Matter: Hair was found in product
Sold states
Nationwide within in the USA
Affected count
59,425 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0725-2026More Fresenius Kabi USA, LLC recalls
- FDA-Drug2026-07-29Fresenius Kabi Naropin injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-06-17Fresenius Kabi epinephrine injection recalled for failed impurity specifications
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