FDA Drug recall D-0502-2025
LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal…
- FDA Drug
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal… by Tailstorm Health, citing lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0502-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-02 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Tailstorm Health |
| Distribution | US |
Product
LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0037-0.
Reason
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Identifiers
| code_info | Lot #s: 2503004, Exp. 3/23/2026; 2503005, Exp. 3/25/2026 |
|---|
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-0502-2025%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.