KETAmine Hydrochloride Injection — Class II drug recall D-0501-2025
Ongoing recall by Tailstorm Health INC, reported 2025-07-09, distributed nationwide. Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing proce
| Recall number | D-0501-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tailstorm Health INC, Phoenix, AZ, United States |
| Recall initiated | 2025-06-02 |
| Classified | 2025-06-30 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 14,725 vials |
| Reason classes | sterility |
| NDC | 81483-0007-02 |
| Lot numbers | 2502009 |
| Expiration dates | 2026-03-02 |
Product
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.
Reason for recall
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0501-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.