The Recall Desk
HighFDA (Drugs)·D-0498-2025·Announced 2025-07-09

[pending] LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, Fo

Pending LLM rewrite. Source: FDA_DRUG D-0498-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

The recalled product

Product
LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 8522
Manufacturer
Tailstorm Health INC

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: 2502004
  • Exp. 2/18/27
  • 2503003
  • Exp. 3/19/27

Distribution

Distributed nationwide across the United States.