Lidocaine with Epinephrine Injection Recalled Due to Manufacturing Sterility Concerns
Tailstorm Health INC is recalling 2,825 vials of Lidocaine HCL 1% with Epinephrine due to FDA concerns about the sterile manufacturing process. No illnesses have been reported.
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: This is an FDA Class II recall involving a sterile injection product with potential contamination risk due to manufacturing process concerns identified during inspection. No illnesses or injuries have been reported, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Tailstorm Health INC is recalling 2,825 vials of Lidocaine HCL Sterile Injection, USP 1% (100 mg/10 mL) with Epinephrine 1:100,000, 10 mL single-dose vials, due to FDA concerns about the sterile manufacturing process. A recent FDA inspection identified concerns with the sterility assurance of the compounded drug manufactured by Medivant Healthcare in Chandler, Arizona.
The affected lots are #2503004 (expiration 3/23/2026) and #2503005 (expiration 3/25/2026). These vials have been distributed nationwide and are used for infiltration and nerve blocks, including caudal and epidural use, in office settings.
If you have these products, stop using them and contact your healthcare provider or pharmacist. No illnesses or injuries have been reported in connection with this recall.
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 — Sterile Injectable
- Hazard
- sterility-concern
- contamination-risk
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.
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