CLASS II ONGOING Drug recall · Reported 17 Jul 2024 · FDA Enforcement Report
Lidocaine HCL Injection, USP 2% 200mg/ (20mg/mL) recalled
Tailstorm Health is recalling Lidocaine HCL Injection, USP 2% 200mg/ (20mg/mL) and Epinephrine HCl 1:200 Dose Vial, distributed nationwide in the US. The recall was initiated on 3 Jul 2024 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-0594-2024
- FDA event ID
- 94930
- Recalling firm
- Tailstorm Health, Chandler, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jul 2024
- FDA classified
- 10 Jul 2024
- Reported
- 17 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 3 Jul 2024 | Recall initiated by company | |
| 10 Jul 2024 | Classified by FDA | +7 days |
| 17 Jul 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: reduced efficacy for epinephrine
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Subpotent Drug: reduced efficacy for epinephrine
Which lots are affected?
Lot Number: 2311003, Expiration Date: 11/13/2024
Where was it sold?
Nationwide in the USA
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.
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 | LIDOcaine HCl Injection, USP, 10mg/mL recalled by Tailstorm Health | 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 |
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 |