Compounded ketamine multi-dose vials recalled over sterility assurance concerns
Ketamine Hydrochloride Injection 500 mg/5 mL multi-dose vials compounded by Medivant Healthcare are being recalled for lack of assurance of sterility. 14,725 vials are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: an injectable with no assurance of sterility, where no infection or injury is reported in the source.
Plain-English summary
Ketamine Hydrochloride Injection, USP, 500 mg/5 mL (10 mg/mL), for intramuscular use or slow intravenous use, 5 mL sterile multi-dose vial, prescription only, for office use only, compounded by Medivant Healthcare of Chandler, Arizona, is being recalled. The action covers 14,725 vials.
The stated reason is a lack of assurance of sterility: a recent FDA inspection revealed concerns with the sterile manufacturing process. The FDA classified the action as Class II.
The affected lot is 2502009, expiring 3/2/2026. Distribution was nationwide in the US. The vials are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the lot number above, stop using it, and follow the instructions issued by the compounder.
The recalled product
- 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.
- Manufacturer
- Tailstorm Health INC
- Category
- Drug — Compounded injectable
- Affected units
- 14,725
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 2502009
- Exp. 3/2/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Tailstorm Health INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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