Fresenius Kabi glycopyrrolate injection recalled for hair 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.
From the FDA notice · Read the official notice ↗ · All Fresenius Kabi recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the 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
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 5 products — see all of them.
Details
- Units affected
- 59,425 vials
- Illnesses reported
- None reported
- Manufactured in
- 3 Corporate Dr, N/A, Lake Zurich, IL, United States
- Classification
- Class II
- Recall number
- D-0725-2026
In the FDA's words
- Description
- 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 Presence of Particulate Matter: Hair was found in product Lot #: 6134349, 6134620 Exp. Date 11/2026 Distribution: Nationwide within in the USA Affected quantity: 59,425 vials
- Hazard
- Presence of Particulate Matter: Hair was found in product
5 products in this recall
Fresenius Kabi Xylocaine, Naropin and more recalled over hair
Fresenius Kabi is recalling five injectable medicine products because hair was found in some vials. The products are Xylocaine (two sizes), Naropin, lidocaine HCl injection and glycopyrrolate injection, all made by Fresenius Kabi in Lake Zurich, Illinois, and sold nationwide. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- 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… (this page)D-0725-2026 · 59,425 vials
- Lidocaine 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 600…D-0726-2026 · 181,225 vials
- Naropin (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, Lake…D-0727-2026 · 92,600 vials
- Xylocaine (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-0728-2026 · 93,250 vials
- Xylocaine (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,…D-0729-2026 · 37,250 vials
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