Bupivacaine HCL Sterile Injection Recalled for Sterility Assurance Concerns
Tailstorm Health Inc. is recalling bupivacaine HCL sterile injection vials nationwide due to FDA inspection findings regarding concerns with the sterile manufacturing process.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug with identified manufacturing process defects affecting sterility assurance. Per the rubric, FDA Class II recalls are scored at 4 (Severe) when there are manufacturing or process integrity concerns with injectable products that could lead to serious adverse health consequences, even without reported illnesses.
Plain-English summary
Tailstorm Health Inc. is recalling bupivacaine HCL sterile injection, USP with epinephrine 1:200,000, 50 mg/10mL, 0.5% (5mg/mL) in 10 mL sterile single-dose vials. The recall affects 975 vials distributed nationwide in the United States.
An FDA inspection identified concerns with the sterile manufacturing process, creating a lack of assurance of sterility for the affected vials. The recalled lot numbers are 2502005 (expiration 2/20/26) and 2502006 (expiration 2/23/2026).
Healthcare providers who have received these vials should stop using them immediately and contact Tailstorm Health Inc. for instructions on return or destruction. Patients who may have received this product should consult with their healthcare provider about the recall.
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…
- Manufacturer
- Tailstorm Health INC
- Category
- Drug — Sterile Injectable
- Affected units
- 975
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.
Part of a larger recall action
This product is one of 6 recalled by Tailstorm Health INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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