Moderate riskFDA DrugClass II

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

  1. Check vials for lot numbers 6134349 or 6134620 (expiration 11/2026)
  2. Do not use affected vials; quarantine them
  3. Contact Fresenius Kabi or your pharmacy for replacement product
  4. 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.

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