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…
- FDA Drug
- Class II
- ongoing
- Published 2026-07-29
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
| Agency | FDA Drug |
|---|---|
| Recall number | D-0728-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-16 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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
| ndc | 63323-492-04 |
|---|---|
| ndc | 63323-492-27 |
| ndc | 63323-492-09 |
| ndc | 63323-492-57 |
| ndc | 63323-492-07 |
| ndc | 63323-492-37 |
| ndc | 63323-492-03 |
| ndc | 63323-492-31 |
| ndc | 63323-491-01 |
| ndc | 63323-491-57 |
| ndc | 63323-495-09 |
| ndc | 63323-495-27 |
| ndc | 63323-495-04 |
| ndc | 63323-495-07 |
| ndc | 63323-485-01 |
| ndc | 63323-485-27 |
| ndc | 63323-485-03 |
| ndc | 63323-485-57 |
| ndc | 63323-486-01 |
| ndc | 63323-486-17 |
| ndc | 63323-486-02 |
| ndc | 63323-486-27 |
| ndc | 63323-486-05 |
| ndc | 63323-486-57 |
| ndc | 63323-484-57 |
| ndc | 63323-489-02 |
| ndc | 63323-489-27 |
| ndc | 63323-489-03 |
| ndc | 63323-489-21 |
| ndc | 63323-489-01 |
| ndc | 63323-489-17 |
| ndc | 63323-488-07 |
| ndc | 63323-488-37 |
| ndc | 63323-488-03 |
| ndc | 63323-488-31 |
| ndc | 63323-488-01 |
| ndc | 63323-488-17 |
| ndc | 63323-481-01 |
| ndc | 63323-481-57 |
| ndc | 63323-483-03 |
| ndc | 63323-483-27 |
| ndc | 63323-483-01 |
| ndc | 63323-483-57 |
| ndc | 63323-482-01 |
| ndc | 63323-482-17 |
| ndc | 63323-482-03 |
| ndc | 63323-482-27 |
| ndc | 63323-482-05 |
| ndc | 63323-482-57 |
| ndc | 63323-487-01 |
| ndc | 63323-487-17 |
| ndc | 63323-487-07 |
| ndc | 63323-487-37 |
| ndc | 63323-487-03 |
| ndc | 63323-487-31 |
| code_info | Lot #: 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.