Class II · Moderate risk
ketamine HCl
Lack of Assurance of Sterility
Ketamine Hydrochloride Injectable Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Affected NDC
73702-0302-31
Compare with the code on your package — it is the most precise check available.
Drug: Ketamine
- Recalling firm
- Wells Pharma of Houston LLC
- NDC code
- 73702-302-31
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0507-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Ketamine recalls
See all
Class III · Low risk
Ketamine Hydrochloride
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
KETAmine Hydrochloride Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
KETAmine Hydrochloride Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
Ketamine HCl 50mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
Other recalls by Wells Pharma of Houston LLC
All 2026 recalls
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
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