FDAClass IIJuly 9, 2025

LIDOcaine HCl Injection recall: Sterility Concern

LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal &…

Why was LIDOcaine HCl Injection recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #s: 2502004, Exp. 2/18/27; 2503003, Exp. 3/19/27

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 &…
Recalling firm
Tailstorm Health INC
Quantity
29,700 vials
Distribution
Nationwide in the US
Recall date
July 9, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls