CLASS II ONGOING Drug recall · Reported 6 May 2026 · FDA Enforcement Report
Ketamine Hydrochloride Injectable Solution, 50mg/ml recalled
Wells Pharma of Houston is recalling Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume:, 5265 Kitty, distributed nationwide in the US. The recall was initiated on 1 Apr 2026 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-0507-2026
- FDA event ID
- 98694
- Recalling firm
- Wells Pharma of Houston, Houston, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Apr 2026
- FDA classified
- 28 Apr 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Apr 2026 | Recall initiated by company | |
| 28 Apr 2026 | Classified by FDA | +27 days |
| 6 May 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations.
Product as listed by the FDA
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Where it was distributed
U.S. Nationwide.
Questions about this recall
Why was it recalled?
cGMP deviations.
Which lots are affected?
120925302312764, Exp Date 04/09/2026, 123125302312879 Exp Date, 05/05/2026, 123125302312880, Exp Date 05/05/2026, 010226302310003, Exp Date 05/06/2026, 010626302310007, Exp Date 05/08/2026, 010626302310008, Exp Date 05/08/2026 020426302310243, Exp Date 06/06/2026.
Where was it sold?
U.S. Nationwide.
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
6 other products · FDA event 98694More recalls from Wells Pharma of Houston
All 8Other Ketamine recalls
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 Hydrochloride Injection, USP, 50 mg/ (10 mg/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 |