FDA Recall D-0499-2025

Tailstorm Health INC · Phoenix, AZ

Class II Ongoing 346 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot #s: 2502005, Exp. 2/20/26; 2502006, Exp 2/23/2026

Quantity: 975 vials

Reason for recall

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Recall record

Recall number: D-0499-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: Nationwide in the US
Recall initiated: 2025-06-02
Classified by FDA Center: 2025-06-30
FDA published: 2025-07-09
Recalling firm: Tailstorm Health INC
Firm location: Phoenix, AZ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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