CLASS II ONGOING Drug recall · Reported 9 Jul 2025 · FDA Enforcement Report
LIDOcaine HCl Injection, USP, 10mg/mL recalled by Tailstorm Health
Tailstorm Health is recalling LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/ Sterile Single Dose Vial, distributed nationwide in the US. The recall was initiated on 2 Jun 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0498-2025
- FDA event ID
- 96996
- Recalling firm
- Tailstorm Health, Phoenix, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jun 2025
- FDA classified
- 30 Jun 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 2 Jun 2025 | Recall initiated by company | |
| 30 Jun 2025 | Classified by FDA | +28 days |
| 9 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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, 85226, NDC 81483-0000-0.
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Which lots are affected?
Lot #s: 2502004, Exp. 2/18/27; 2503003, Exp. 3/19/27
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 96996This product is part of a recall event; the main page for the event is KETAmine Hydrochloride Injection, USP, 50 mg/ (10 mg/mL) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | KETAmine Hydrochloride Injection, USP, 50 mg/ (10 mg/mL) recalled | Tailstorm Health | Sterility | Nationwide | |
| CLASS II | LIDOcaine HCL Sterile Injection, USP, 100mg/, 1%, (10mg/mL) recalled | Tailstorm Health | Sterility | Nationwide | |
| CLASS II | KETAmine Hydrochloride Injection, USP, 500mg/, (10mg/mL) recalled | Tailstorm Health | Sterility | Nationwide | |
| CLASS II | BUPIVAcaine HCL Sterile injection recalled by Tailstorm Health | Tailstorm Health | Sterility | Nationwide | |
| CLASS II | LIDOcaine HCL Sterile Injection, USP, 20 mg/mL recalled | Tailstorm Health | Sterility | Nationwide |
More recalls from Tailstorm Health
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | LIDOcaine HCL Sterile Injection, USP, 20 mg/mL recalled | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | BUPIVAcaine HCL Sterile injection recalled by Tailstorm Health | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | KETAmine Hydrochloride Injection, USP, 500mg/, (10mg/mL) recalled | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | LIDOcaine HCL Sterile Injection, USP, 100mg/, 1%, (10mg/mL) recalled | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | KETAmine Hydrochloride Injection, USP, 50 mg/ (10 mg/mL) recalled | Tailstorm Health | Sterility | Nationwide |
Other Lidocaine recalls
All 119| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Lidolog Kit, Kit Contains: Lidocaine HCl Injection recalledLidolog Kit | Asclemed USA | Other | TN |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection USP, 1% (10 mg/mL) single dose ampule recalledLidocaine Hydrochloride | Asclemed USA | Sterility | Nationwide |