CLASS II ONGOING Drug recall · Reported 9 Jul 2025 · FDA Enforcement Report
KETAmine Hydrochloride Injection, USP, 50 mg/ (10 mg/mL) recalled
Tailstorm Health is recalling KETAmine Hydrochloride Injection, USP, 50 mg/ (10 mg/mL), For IM Use or Slow IV Use, distributed nationwide in the US. The recall was initiated on 2 Jun 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0500-2025
- FDA event ID
- 96996
- Recalling firm
- Tailstorm Health, Phoenix, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jun 2025
- FDA classified
- 30 Jun 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Jun 2025 | Recall initiated by company | |
| 30 Jun 2025 | Classified by FDA | +28 days |
| 9 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Which lots are affected?
Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 96996| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | LIDOcaine HCL Sterile Injection, USP, 100mg/, 1%, (10mg/mL) recalled | Tailstorm Health | Sterility | Nationwide | |
| CLASS II | KETAmine Hydrochloride Injection, USP, 500mg/, (10mg/mL) recalled | Tailstorm Health | Sterility | Nationwide | |
| CLASS II | BUPIVAcaine HCL Sterile injection recalled by Tailstorm Health | Tailstorm Health | Sterility | Nationwide | |
| CLASS II | LIDOcaine HCl Injection, USP, 10mg/mL recalled by Tailstorm Health | Tailstorm Health | Sterility | Nationwide | |
| CLASS II | LIDOcaine HCL Sterile Injection, USP, 20 mg/mL recalled | Tailstorm Health | Sterility | Nationwide |
More recalls from Tailstorm Health
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | LIDOcaine HCL Sterile Injection, USP, 20 mg/mL recalled | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | LIDOcaine HCl Injection, USP, 10mg/mL recalled by Tailstorm Health | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | BUPIVAcaine HCL Sterile injection recalled by Tailstorm Health | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | KETAmine Hydrochloride Injection, USP, 500mg/, (10mg/mL) recalled | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | LIDOcaine HCL Sterile Injection, USP, 100mg/, 1%, (10mg/mL) recalled | Tailstorm Health | Sterility | Nationwide |
Other Ketamine recalls
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketamine Hydrochloride Injectable Solution, 50mg/ml recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | ketamine HCl, 1,000 mg, 1,000 mg per (10 mg per mL) recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS III | Ketamine Hydrochloride, 50mg/ (10mg/mL), Injection recalled | Staq Pharma | Other | Nationwide |
| Drug | CLASS II | KETAmine Hydrochloride Injection, USP, 500mg/, (10mg/mL) recalled | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | ketamine in 0.9% sodium chloride, 50 mg/ (10mg/mL) syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |