RecallRadar

FDA Drug recall D-0725-2026

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…

On 2026-07-29 the FDA classified a Class II recall of 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… by Fresenius Kabi Usa, citing presence of Particulate Matter: Hair was found in product.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0725-2026
ClassificationClass II
Statusongoing
Initiated2026-07-16
Published2026-07-29
Last updated2026-09-13 11:52 UTC
CompanyFresenius Kabi Usa
DistributionUS

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

Reason

Presence of Particulate Matter: Hair was found in product

Identifiers

ndc63323-578-03
ndc63323-578-01
ndc63323-578-04
ndc63323-578-02
ndc63323-578-07
ndc63323-578-05
ndc63323-578-18
ndc63323-578-20
code_infoLot #: 6134349, 6134620 Exp. Date 11/2026

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0725-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.