Notice names this product. Fresenius Kabi USA’s Glycopyrrolate Injection is named in FDA Class II recall D-0725-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Presence of Particulate Matter: Hair was found in product Identifying details: Lot #: 6134349, 6134620 Exp. Date 11/2026. Units affected: 59,425 vials. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
Glycopyrrolate Injection
Company / brand
Fresenius Kabi USA
Lot / serial / date codes
Lot #: 6134349, 6134620 Exp. Date 11/2026
Distribution
Nationwide within in the USA
Agency product description and boundaries
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.