Class II · Moderate risk
Ketamine Hydrochloride Injectable Solution
cGMP deviations.
Is Ketamine recalled?
Yes — there is an active recall. 8 ongoing FDA recalls mention Ketamine (46 total). Check the affected lots below.
Most common reason: Sterility / contamination (32 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ketamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Ketamine recalls in 2026
2 initiated in 2026, 46 in total — newest first
Class II · Moderate risk
ketamine HCl
Lack of Assurance of Sterility
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.
Class II · Moderate risk
ketamine inj 50 mg per 1 mL
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II · Moderate risk
ketamine in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
ketamine in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
Ketamine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine 50mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Ketamine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine HCl 150 mg
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine Hydrochloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine Hydrochloride Injection
Lack of Assurance of Sterility
Class III · Low risk
Ketamine HCl Injection Solution
Labeling: Incorrect Exp. Date: Incorrect BUD.
Class II · Moderate risk
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I · High risk
Class II · Moderate risk
Ketamine 50 mg Infusion
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use
Lack of Assurance of Sterility.
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