Why it was recalled
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #s: 2502005, Exp. 2/20/26; 2502006, Exp 2/23/2026
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0499-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 2, 2025
- FDA report date
- Jul 9, 2025
- Quantity
- 975 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tailstorm Health INC
Original FDA data
Every field from FDA enforcement report D-0499-2025, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96996
- Address
- 24416 N 19th Ave Ste 200
- Code information
- Lot #s: 2502005, Exp. 2/20/26; 2502006, Exp 2/23/2026
- Postal code
- 85085-1400
- Report date
- Jul 9, 2025
- Product type
- Drugs
- Recall number
- D-0499-2025
- Classification
- Class II
- Recalling firm
- Tailstorm Health INC
- Product quantity
- 975 vials
- Reason for recall
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jun 2, 2025
- Center classification date
- Jun 30, 2025