Class II · Moderate risk
Ketamine Hydrochloride Injectable Solution
cGMP deviations.
ketamine HCl
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56
Affected NDC
71506-0050-56
Compare with the code on your package — it is the most precise check available.
Drug: Ketamine
- Recalling firm
- Fresenius Kabi Compounding, LLC
- NDC code
- 71506-050-56
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0334-2026 · 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 Fresenius Kabi Compounding, LLC
All 2026 recalls
Class II · Moderate risk
vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
thiamine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
acyclovir sodium
Lack of Assurance of Sterility
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