FDA Drugs recall ·
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000… recall
- Recall number
- D-0499-2025
- Date
- (initiated June 2, 2025)
- Company / brand
- Tailstorm Health INC
24416 N 19th Ave Ste 200, Phoenix, AZ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 975 vials
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.
Why was it recalled?
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #s: 2502005, Exp. 2/20/26; 2502006, Exp 2/23/2026
Distribution
Nationwide in the US
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0499-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.