KETAmine Hydrochloride Injection recall
FDA recall D-0501-2025 · initiated Jun 2, 2025
Tailstorm Health INC recalled KETAmine Hydrochloride Injection in Jun 2025 — an FDA Class II recall (D-0501-2025) because Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 14,725 vials
Details
- 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.
- Recalling company
- Tailstorm Health INC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Jun 2, 2025
- FDA report date
- Jul 9, 2025
Frequently asked
- Was KETAmine Hydrochloride Injection recalled?
- Tailstorm Health INC recalled KETAmine Hydrochloride Injection in Jun 2025 — an FDA Class II recall (D-0501-2025) because Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was KETAmine Hydrochloride Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0501-2025 was: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Is a recalled KETAmine Hydrochloride Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of KETAmine Hydrochloride Injection are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot: 2502009, Exp. 3/2/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0501-2025.