← FDA ENFORCEMENT
D-0725-2026Class II

Fresenius Kabi USA, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Fresenius Kabi USA, LLC
Product type
Drug
Status
Ongoing
Report date
2026-07-29
Distribution
Nationwide within in the USA
Firm state
IL
Product quantity
59,425 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of Particulate Matter: Hair was found in product

Product 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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →