Class II · Moderate risk
Ketamine 10 Mg/Ml Inj Sol Syr
Lack of Assurance of Sterility
Is Ketamine recalled?
Yes — there is an active recall. 8 ongoing FDA recalls mention Ketamine (46 total). Check the affected lots below.
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 on record
none so far in 2026; 46 on record, newest first
Class II · Moderate risk
Ketamine 50 Mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine HCl USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Ketamine HCl Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Ketamine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Ketamine HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL…
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine 20 mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine 100mg/mL 1mL fill 3 mL syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe
Lack of Assurance of Sterility
Class II · Moderate risk
All ketamine and amitriptyline Products
Lack of Processing Controls
Class II · Moderate risk
Ketamine Hydrochloride Injection
Defective Container: There were customer complaints of cracked and leaking glass vials.
Class II · Moderate risk
Ketamine 50 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
Ketamine 100 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
ketamine HCl Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
ketamine HCl Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
ketamine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
ketamine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
ketamine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Keto 10%-Gabap 10%-Ketamine 2% Cream
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Ketamine 100 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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