Compounded Lidocaine-Epinephrine Injectable Recalled Nationwide for Subpotent Epinephrine
Tailstorm Health Inc is recalling a compounded lidocaine-epinephrine injection nationwide due to subpotent epinephrine component. The recall affects 12,525 vials of lot number 2311003.
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 FDA Class II recall involves subpotency of epinephrine in a compounded injectable drug without reported illnesses or injuries. The product represents a risk of reduced therapeutic effect in emergency situations, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tailstorm Health Inc is recalling compounded Lidocaine HCL Injection, USP 2% with Epinephrine HCl 1:200,000 in 10 mL single-dose vials. The product, manufactured by Medivant Healthcare in Chandler, Arizona, has NDC 81483-0038-0.
The recall was initiated due to subpotency of the epinephrine component, meaning the epinephrine has reduced efficacy compared to what is specified on the label. This could result in lower-than-expected therapeutic effect when the product is used.
The recall affects 12,525 10 mL vials distributed nationwide in the USA under lot number 2311003 with an expiration date of November 13, 2024. Healthcare providers and patients who have this product should stop using it and contact their healthcare provider. The product should be returned to the pharmacy or manufacturer.
The recalled product
- Product
- 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
- Manufacturer
- TAILSTORM HEALTH INC
- Category
- Drug — Injectable / Compounded
- Hazard
- subpotency
- reduced-efficacy
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 (2)
- Lot Number: 2311003
- Expiration Date: 11/13/2024
Distribution
Distributed nationwide across the United States.
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