RecallRadar

FDA Drug recall D-0728-2026

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius K…

On 2026-07-29 the FDA classified a Class II recall of Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius K… by Fresenius Kabi Usa, citing presence of Particulate Matter: Hair was found in products.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0728-2026
ClassificationClass II
Statusongoing
Initiated2026-07-16
Published2026-07-29
Last updated2026-09-13 11:52 UTC
CompanyFresenius Kabi Usa
DistributionUS

Product

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01

Reason

Presence of Particulate Matter: Hair was found in products

Identifiers

ndc63323-492-04
ndc63323-492-27
ndc63323-492-09
ndc63323-492-57
ndc63323-492-07
ndc63323-492-37
ndc63323-492-03
ndc63323-492-31
ndc63323-491-01
ndc63323-491-57
ndc63323-495-09
ndc63323-495-27
ndc63323-495-04
ndc63323-495-07
ndc63323-485-01
ndc63323-485-27
ndc63323-485-03
ndc63323-485-57
ndc63323-486-01
ndc63323-486-17
ndc63323-486-02
ndc63323-486-27
ndc63323-486-05
ndc63323-486-57
ndc63323-484-57
ndc63323-489-02
ndc63323-489-27
ndc63323-489-03
ndc63323-489-21
ndc63323-489-01
ndc63323-489-17
ndc63323-488-07
ndc63323-488-37
ndc63323-488-03
ndc63323-488-31
ndc63323-488-01
ndc63323-488-17
ndc63323-481-01
ndc63323-481-57
ndc63323-483-03
ndc63323-483-27
ndc63323-483-01
ndc63323-483-57
ndc63323-482-01
ndc63323-482-17
ndc63323-482-03
ndc63323-482-27
ndc63323-482-05
ndc63323-482-57
ndc63323-487-01
ndc63323-487-17
ndc63323-487-07
ndc63323-487-37
ndc63323-487-03
ndc63323-487-31
code_infoLot #: 6130235, Exp. Date 02/2027

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-0728-2026%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.