FDA Drug recall D-0499-2025
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Ne…
- FDA Drug
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Ne… 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-0499-2025 |
| 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
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.
Reason
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Identifiers
| code_info | Lot #s: 2502005, Exp. 2/20/26; 2502006, Exp 2/23/2026 |
|---|
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-0499-2025%22
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