Bupivacaine with epinephrine sterile injection recalled for sterility manufacturing concerns
Tailstorm Health is recalling bupivacaine HCL with epinephrine sterile injections due to FDA-identified concerns with the sterile manufacturing process that could affect product sterility.
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: FDA Class II recall for a sterile injectable with manufacturing process concerns that could compromise sterility. Although no illnesses or injuries have been reported, the inherent risk of sterile process failure in an injectable anesthetic product qualifies as a risk-of-harm scenario without reported injury.
Plain-English summary
Tailstorm Health Inc is recalling BUPIVAcaine HCL Sterile injection with epinephrine (0.5%, 50 mg/10 mL) distributed nationwide. The recall affects 975 vials across two lot numbers: 2502005 (exp. 2/20/26) and 2502006 (exp. 2/23/26).
A recent FDA inspection identified concerns with the sterile manufacturing process. The product is a single-dose vial intended for nerve block, caudal, and epidural anesthesia and is compounded by Medivant Healthcare in Chandler, Arizona.
Healthcare facilities and medical professionals currently using this product should cease use immediately and contact Tailstorm Health Inc or Medivant Healthcare for further guidance on product disposition and replacement options.
The recalled product
- Product
- BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S
- Manufacturer
- Tailstorm Health INC
- Category
- Drug — Injectable / Anesthetic
- Hazard
- sterility-failure
- contamination
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: 2502005
- Exp. 2/20/26
- 2502006
- Exp 2/23/2026
Distribution
Distributed nationwide across the United States.
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