Lidocaine HCL Sterile Injection recalled for sterility assurance concerns
Tailstorm Health INC is recalling Lidocaine HCL Sterile Injection (20 mg/mL) due to FDA inspection findings of concerns with the sterile manufacturing process. The recalled product is distributed nationwide.
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: The FDA classified this as a Class II recall. Lidocaine HCL is an injectable pharmaceutical with a lack of sterility assurance from a manufacturing defect, which poses a serious risk of infection if administered. This meets the threshold for Severe under the rubric.
Plain-English summary
Tailstorm Health INC is recalling Lidocaine HCL Sterile Injection, USP, 20 mg/mL (200 mg/10 mL), in 10 mL sterile single-dose vials. The product is used for infiltration and nerve block procedures, including caudal and epidural use. Lot #2504003 with expiration date 04/03/2027 (NDC 81483-0001-0) is affected. Approximately 4,875 vials have been distributed nationwide in the United States.
The recall was initiated following an FDA inspection that revealed concerns with the sterile manufacturing process, which creates a lack of assurance of sterility for the product.
Consumers and healthcare providers in possession of this product should stop using it and contact Tailstorm Health INC or their supplier for instructions on return or disposal.
The recalled product
- Product
- LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
- Manufacturer
- Tailstorm Health INC
- Affected units
- 4,875
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 #: 2504003
- Exp. 04/03/2027
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.
See all 6 products in this recall →Related recalls
Same manufacturer · Tailstorm Health INC
See all →- HighCompounded preservative-free lidocaine vials lack assurance of sterility
FDA (Drugs) · 2025-07-09
- HighCompounded lidocaine with epinephrine vials lack assurance of sterility
FDA (Drugs) · 2025-07-09
- HighCompounded ketamine injection recalled over lack of sterility assurance concerns
FDA (Drugs) · 2025-07-09
- SevereBupivacaine HCL Sterile Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2025-07-09
- HighCompounded ketamine multi-dose vials recalled over sterility assurance concerns
FDA (Drugs) · 2025-07-09
Same hazard · sterility assurance
See all →- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
Similar recalls
- SevereLidocaine Hydrochloride Injection Recalled for Sterility Assurance
FDA (Drugs) · 2026-07-08
- HighLidocaine Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-06-08
- SevereLidocaine HCl Sterile Buffered Solution Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-02-02
- HighLidocaine HCl injection syringes recalled due to sterility assurance failure
FDA (Drugs) · 2022-07-27
- HighSpectra lidocaine ampules recalled over lack of sterility assurance
FDA (Drugs) · 2026-06-10
- SevereFDA Recalls HCG and Lidocaine Injections Due to Sterility Concerns
FDA (Drugs) · 2015-11-25