Compounded lidocaine with epinephrine vials lack assurance of sterility
Lidocaine HCl Sterile Injection 1% with epinephrine 1:100,000, compounded by Medivant Healthcare, is being recalled for lack of assurance of sterility. 2,825 vials affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where sterility of an injectable cannot be assured, a risk of harm with no injuries reported in the source.
Plain-English summary
Lidocaine HCl Sterile Injection, USP, 100 mg/10 mL, 1% with epinephrine 1:100,000, for infiltration and nerve block including caudal and epidural use, in 10 mL sterile single-dose vials marked for office use only, compounded by Medivant Healthcare of Chandler, Arizona, is being recalled. The recalling firm is Tailstorm Health INC. The action covers 2,825 vials.
The stated reason is lack of assurance of sterility: a recent FDA inspection revealed concerns with the sterile manufacturing process. The FDA classified the action as Class II.
Affected lots are 2503004, expiring 3/23/2026, and 2503005, expiring 3/25/2026. Distribution was nationwide in the US.
Facilities should identify affected stock using the lot numbers above, quarantine it, and follow the instructions issued by the firm.
The recalled product
- 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
- Manufacturer
- Tailstorm Health INC
- Category
- Drug — Compounded injectable
- Affected units
- 2,825
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #s: 2503004
- Exp. 3/23/2026
- 2503005
- Exp. 3/25/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Tailstorm Health INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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