Recall
FDAHealthJuly 16, 2026

Fresenius Kabi USA, LLC — 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:

⚠️ Presence of Particulate Matter: Hair was found in product

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
July 16, 2026

Nationwide within in the USA

What's affected?

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
UPC
0363323578046
Lot code
6134349

Additional details

Lot #: 6134349, 6134620 Exp. Date 11/2026

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 59,425 vials.

View original FDA notice →

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